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TerminatedPhase 1Results posted

Study of TAK-071 in Healthy Participants and Participants With Mild Cognitive Impairment/Mild Alzheimer Disease and Relative Bioavailability (BA) and Food Effect of TAK-071 in Healthy Participants

A Phase 1 Safety, Tolerability, and Pharmacokinetic Study of Escalating Single and Multiple Oral Doses of TAK-071 in Healthy Subjects and Subjects With Mild Cognitive Impairment/Mild Alzheimer Disease and Relative Bioavailability and Food Effect of TAK-071 in Healthy Subjects

Lead sponsor

Takeda

Assets

Donepezil / TAK-071

Listed sites

1

Recruiting sites

-

Enrollment

179

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•Alzheimer's disease•MMSE 18-30

Primary endpoints

•At Least One Treatment-Emergent Adverse Event (TEAE)•Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical•Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02769065
Org study IDTAK-071-1001
RegistryU1111-1176-7435WHO

Timeline

Milestones

Study start2016-05-05actual
Study first posted2016-05-11estimated
Primary completion2017-06-08actual
Study completion2017-06-08actual
Last update posted2019-06-10actual
Results first posted2019-06-10actual

Assets

Drug assets

DonepezilTAK-071

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age18 Years
Maximum age90 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

1. Man or woman who weighs at least 50 kg and has a body mass index (BMI) from 18.0 to 30.0 kg/m^2, inclusive, at Screening. Participants should be aged 18 to 55 years, inclusive (nonelderly at the time of informed consent and first study drug dose) for Cohorts 1 to 12, and 17 to 22; 20 to 55 years, inclusive, for Cohorts 13 to 15; and 55 to 90 years, inclusive, for participants in Cohort 16.

2. For Cohorts 13 to 15 only: First-generation Japanese, defined as having been born in Japan of Japanese parents and Japanese grandparents and living no more than 10 years outside of Japan, with no significant change in lifestyle, including diet, while living outside of Japan.

3. Cohort 16 only: Healthy elderly or participants with MCI or mild AD, who must have Mini Mental State Examination (MMSE) score of 18 to 30, inclusive or 18 to 26 inclusive, respectively, and no biomarker data to contradict this diagnosis. Participants with documented diagnosis of MCI or mild AD must be receiving ongoing donepezil therapy (10 mg) in the evening for a minimum of 21 days prior to Check-in (Day -1) or must consent to take donepezil dose titrated to at least 21 days of treatment with 10 mg QD prior to Check-in

Exclusion criteria

1. Has clinically significant (Cohorts 1 to 15 and 17 to 22) or uncontrolled (Cohort 16) neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal (GI), urologic, immunologic, endocrine, or psychiatric disease or other abnormality (other than the disease being studied), which may impact the ability of the participant to participate or potentially confound the study results.

2. Has a history of type 1 diabetes (Cohorts 1 to 22) or type 2 diabetes (Cohorts 1 to 15, 17 to 22) or hemoglobin A1c >6.5% at Screening. Note: participants with controlled (hemoglobin A1c <7.0% at Screening) type 2 diabetes in Cohort 16 may participate in the study.

3. Has a risk of suicide or suicidal ideation with intent and plan according to the investigator's clinical judgment (affirmative answer to questions 4 and 5 of the ideation section of the Columbia-Suicide Severity Rating Scale) or has made a suicide attempt in the previous 6 months.

4. Cohort 16 only: Any significant neurologic disease (other than suspected incipient or mild AD), such as Parkinson disease, stroke, transient ischemic attack, multi-infarct dementia, Huntington disease, head trauma with clinically significant cognitive sequelae, or chronic central nervous system infection, per investigator discretion.

5. Has current or recent (within 6 months) GI disease that would be expected to influence the absorption of drugs (ie, a history of malabsorption, any surgical intervention known to impact absorption [eg, bariatric surgery or bowel resection], esophageal reflux, peptic ulcer disease, erosive esophagitis, or frequent [more than once per week] occurrence of heartburn).

Endpoints (169)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
113
Other (unclassified)
44
Fluid / digital biomarkers
12

Fluid / digital biomarkers

12 endpoints
Secondary/protocol endpoint

CSF Cmax: Maximum Observed Concentration in Cerebrospinal Fluid (CSF) for TAK-071

Time frame:Pre-dose on Day 1 and at multiple time points (up to 12 hours) post-dose

concentration, descriptive

Secondary/protocol endpoint

CSF Cmax: Maximum Observed Concentration in Cerebrospinal Fluid (CSF) for TAK-071

Time frame:Pre-dose on Day 28 and at multiple time points (up to 36 hours) post-dose

concentration, descriptive

Secondary/protocol endpoint

CSF AUC(0-12): Area Under the CSF Concentration-time Curve From Time 0 to 12 Hours for TAK-071

Time frame:Pre-dose on Day 1 and at multiple time points (up to 12 hours) post-dose

concentration, descriptive

Secondary/protocol endpoint

CSF AUC(0-36): Area Under the CSF Concentration-time Curve From Time 0 to 36 Hours for TAK-071

Time frame:Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose

concentration, descriptive

Secondary/protocol endpoint

Ratio of CSF AUC(0-12) to the Plasma AUC(0-12) for TAK-071

Time frame:Pre-dose on Day 1 and at multiple time points [up to 168 hours] post-dose

concentration, descriptive

Secondary/protocol endpoint

Ratio of CSF AUC(0-36) to the Plasma AUC(0-36) for TAK-071

Time frame:Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose Cohort 9

concentration, descriptive

Secondary/registry result

CSF Cmax: Maximum Observed Concentration in Cerebrospinal Fluid (CSF) for TAK-071

Time frame:Pre-dose on Day 1 and at multiple time points (up to 12 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), ng/mLStandard deviation
SRD: Cohort 3: TAK-071 9 mgn=6 Participants0.0089880.0051582
Secondary/registry result

CSF Cmax: Maximum Observed Concentration in Cerebrospinal Fluid (CSF) for TAK-071

Time frame:Pre-dose on Day 28 and at multiple time points (up to 36 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), ng/mLStandard deviation
MRD: Cohort 9: TAK-071 15 mgn=3 Participants0.011440.0012682
Secondary/registry result

CSF AUC(0-12): Area Under the CSF Concentration-time Curve From Time 0 to 12 Hours for TAK-071

Time frame:Pre-dose on Day 1 and at multiple time points (up to 12 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), h*ng/mLStandard deviation
SRD: Cohort 3: TAK-071 9 mgn=5 Participants13.683.9324
Secondary/registry result

CSF AUC(0-36): Area Under the CSF Concentration-time Curve From Time 0 to 36 Hours for TAK-071

Time frame:Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), h*ng/mLStandard deviation
MRD: Cohort 9: TAK-071 15 mgn=3 Participants360.973.780
Secondary/registry result

Ratio of CSF AUC(0-12) to the Plasma AUC(0-12) for TAK-071

Time frame:Pre-dose on Day 1 and at multiple time points [up to 168 hours] post-dose

concentration, descriptive

Posted result

GroupValue (mean), RatioStandard deviation
SRD: Cohort 3: TAK-071 9 mgn=5 Participants0.0090980.0034530
Secondary/registry result

Ratio of CSF AUC(0-36) to the Plasma AUC(0-36) for TAK-071

Time frame:Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose Cohort 9

concentration, descriptive

Posted result

GroupValue (mean), RatioStandard deviation
MRD: Cohort 9: TAK-071 15 mgn=3 Participants0.011400.0014959

Safety / tolerability / PK

113 endpoints
Primary/protocol endpoint

Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)

Time frame:Day 1 up to Day 41

threshold achievement, event

Primary/protocol endpoint

Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose

Time frame:Day 1 up to Day 41

threshold achievement, event

Primary/protocol endpoint

Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose

Time frame:Day 1 up to Day 41

threshold achievement, event

Primary/protocol endpoint

Tmax: Time of First Occurrence of Cmax for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

concentration, descriptive

Primary/protocol endpoint

Tmax: Time of First Occurrence of Cmax for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1]

Time frame:Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Primary/protocol endpoint

Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 21]

Time frame:Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Primary/protocol endpoint

Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 1]

Time frame:Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose

concentration, descriptive

Primary/protocol endpoint

Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 8]

Time frame:Pre-dose on Day 8 and multiple time points (up to 24 hour) post-dose

concentration, descriptive

Primary/protocol endpoint

Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 28]

Time frame:Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose

concentration, descriptive

Primary/protocol endpoint

Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 1]

Time frame:Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose

concentration, descriptive

Primary/protocol endpoint

Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 8]

Time frame:Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Primary/protocol endpoint

Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 28]

Time frame:Pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Primary/protocol endpoint

Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 1]

Time frame:Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Primary/protocol endpoint

Tmax: Time of First Occurrence of Cmax for TAK-071 Relative Bioavailability and Food Effect

Time frame:Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose

concentration, descriptive

Primary/protocol endpoint

Tmax: Time of First Occurrence of Cmax for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil

Time frame:Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

concentration, descriptive

Primary/protocol endpoint

Cmax: Maximum Observed Plasma Concentration for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

concentration, descriptive

Primary/protocol endpoint

Cmax: Maximum Observed Plasma Concentration for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1]

Time frame:Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Primary/protocol endpoint

Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 21]

Time frame:Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Primary/protocol endpoint

Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 1]

Time frame:Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose

concentration, descriptive

Primary/protocol endpoint

Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 8]

Time frame:Pre-dose on Day 8 and multiple time points (up to 24 hour) post-dose

concentration, descriptive

Primary/protocol endpoint

Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 28]

Time frame:Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose

concentration, descriptive

Primary/protocol endpoint

Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 1]

Time frame:Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose

concentration, descriptive

Primary/protocol endpoint

Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 8]

Time frame:Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Primary/protocol endpoint

Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 28]

Time frame:Pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Primary/protocol endpoint

Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 1]

Time frame:Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Primary/protocol endpoint

Cmax: Maximum Observed Plasma Concentration for TAK-071 Relative Bioavailability and Food Effect

Time frame:Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose

concentration, descriptive

Primary/protocol endpoint

Cmax: Maximum Observed Plasma Concentration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil

Time frame:Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

concentration, descriptive

Primary/protocol endpoint

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

concentration, descriptive

Primary/protocol endpoint

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1]

Time frame:Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Primary/protocol endpoint

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 21]

Time frame:Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Primary/protocol endpoint

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 1]

Time frame:Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose

concentration, descriptive

Primary/protocol endpoint

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 8]

Time frame:Pre-dose on Day 8 and multiple time points (up to 24 hour) post-dose

concentration, descriptive

Primary/registry result

Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)

Time frame:Day 1 up to Day 41

threshold achievement, event

Posted result

GroupValue (number), percentage of participantsReported bounds
SRD: Placebo Cohorts 1-6, 18 and 19n=16 Participants25.0-
SRD: Cohort 1: TAK-071 1 mgn=6 Participants33.3-
SRD: Cohort 2: TAK-071 3 mgn=6 Participants0-
SRD: Cohort 3: TAK-071 9 mgn=6 Participants66.7-
SRD: Cohort 4: TAK-071 20 mgn=6 Participants33.3-
SRD: Cohort 5: TAK-071 40 mgn=6 Participants0-
SRD: Cohort 6: TAK-071 80 mgn=6 Participants16.7-
MRD: Placebo Cohorts 7-9n=6 Participants50.0-
MRD: Cohort 7: TAK-071 3 mgn=6 Participants16.7-
MRD: Cohort 8: TAK-071 9 mgn=6 Participants16.7-
MRD: Cohort 9: TAK-071 15 mgn=6 Participants50.0-
MRD: TAK-071 Placebo Cohorts 10-12+Donepeziln=6 Participants33.3-
MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mgn=6 Participants33.3-
MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mgn=6 Participants50.0-
MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mgn=6 Participants50.0-
MRD: Placebo Cohorts 13-15n=3 Participants66.7-
MRD: Cohort 13: TAK-071 3 mgn=5 Participants40.0-
MRD: Cohort 14: TAK-071 9 mgn=5 Participants40.0-
MRD: Cohort 15: TAK-071 15 mgn=5 Participants60.0-
Bioavailability (BA)/Food Effect: Cohort 17 Regimen An=12 Participants16.7-
BA/Food Effect: Cohort 17 Regimen Bn=12 Participants8.3-
BA/Food Effect: Cohort 17 Regimen Cn=12 Participants8.3-
SRD: Cohort 18: TAK-071 120 mgn=6 Participants0-
SRD: Cohort 19: TAK-071 160 mgn=6 Participants33.3-
SRD: TAK-071 Placebo+Donepezil Placebon=9 Participants44.4-
SRD: TAK-071 Placebo+Donepeziln=9 Participants55.6-
SRD: Cohort 20: TAK-071 40 mg+Donepeziln=5 Participants80.0-
SRD: Cohort 21: TAK-071 60 mg+Donepeziln=6 Participants100-
SRD: Cohort 22: TAK-071 80 mg+Donepeziln=6 Participants83.3-
Primary/protocol endpoint

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 28]

Time frame:Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose

concentration, descriptive

Primary/protocol endpoint

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 1]

Time frame:Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose

concentration, descriptive

Primary/registry result

Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose

Time frame:Day 1 up to Day 41

threshold achievement, event

Posted result

GroupValue (number), percentage of participantsReported bounds
SRD: Placebo Cohorts 1-6, 18 and 19Systolic Blood Pressure (SBP), Supine, <85 mmHgn=16 Participants0-
SBP, Supine, >180 mmHgn=16 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=16 Participants0-
SBP, 5 min Supine, >180 mmHgn=16 Participants0-
SBP, 1 min Standing, <85 mmHgn=16 Participants0-
SBP, 1 min Standing, >180 mmHgn=16 Participants0-
SBP, 3 min Standing, <85 mmHgn=16 Participants0-
SBP, 3 min Standing, >180 mmHgn=16 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=16 Participants0-
DBP, Supine, >110 mmHgn=16 Participants0-
DBP, 5 min supine, <50 mmHgn=16 Participants0-
DBP, 5 min Supine, >110 mmHgn=16 Participants0-
DBP, 1 min Standing, <50 mmHgn=16 Participants0-
DBP, 1 min Standing, >110 mmHgn=16 Participants0-
DBP, 3 min Standing, <50 mmHgn=16 Participants0-
DBP, 3 min Standing, >110 mmHgn=16 Participants0-
Pulse, Supine, <50 beats/min (bpm)n=16 Participants6.3-
Pulse, Supine, >120 beats/minn=16 Participants6.3-
Pulse, 5 min Supine, <50 beats/minn=16 Participants25.0-
Pulse, 5 min Supine, >120 beats/minn=16 Participants0-
Pulse, 1 min Standing, <50 beats/minn=16 Participants0-
Pulse, 1 min Standing, >120 beats/minn=16 Participants6.3-
Pulse, 3 min Standing, <50 beats/minn=16 Participants0-
Pulse, 3 min Standing, >120 beats/minn=16 Participants0-
Temperature, <35.6 Celsius (C)n=16 Participants0-
Temperature, >37.7 Cn=16 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=16 Participants12.5-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=16 Participants6.3-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=16 Participants0-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=16 Participants0-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=16 Participants75.0-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=16 Participants75.0-
SRD: Cohort 1: TAK-071 1 mgSystolic Blood Pressure (SBP), Supine, <85 mmHgn=6 Participants0-
SBP, Supine, >180 mmHgn=6 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=6 Participants0-
SBP, 5 min Supine, >180 mmHgn=6 Participants0-
SBP, 1 min Standing, <85 mmHgn=6 Participants0-
SBP, 1 min Standing, >180 mmHgn=6 Participants0-
SBP, 3 min Standing, <85 mmHgn=6 Participants0-
SBP, 3 min Standing, >180 mmHgn=6 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=6 Participants0-
DBP, Supine, >110 mmHgn=6 Participants0-
DBP, 5 min supine, <50 mmHgn=6 Participants0-
DBP, 5 min Supine, >110 mmHgn=6 Participants0-
DBP, 1 min Standing, <50 mmHgn=6 Participants0-
DBP, 1 min Standing, >110 mmHgn=6 Participants0-
DBP, 3 min Standing, <50 mmHgn=6 Participants0-
DBP, 3 min Standing, >110 mmHgn=6 Participants0-
Pulse, Supine, <50 beats/min (bpm)n=6 Participants33.3-
Pulse, Supine, >120 beats/minn=6 Participants0-
Pulse, 5 min Supine, <50 beats/minn=6 Participants0-
Pulse, 5 min Supine, >120 beats/minn=6 Participants0-
Pulse, 1 min Standing, <50 beats/minn=6 Participants0-
Pulse, 1 min Standing, >120 beats/minn=6 Participants0-
Pulse, 3 min Standing, <50 beats/minn=6 Participants0-
Pulse, 3 min Standing, >120 beats/minn=6 Participants0-
Temperature, <35.6 Celsius (C)n=6 Participants0-
Temperature, >37.7 Cn=6 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=6 Participants0-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=6 Participants0-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=6 Participants0-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=6 Participants0-
SRD: Cohort 2: TAK-071 3 mgSystolic Blood Pressure (SBP), Supine, <85 mmHgn=6 Participants0-
SBP, Supine, >180 mmHgn=6 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=6 Participants0-
SBP, 5 min Supine, >180 mmHgn=6 Participants0-
SBP, 1 min Standing, <85 mmHgn=6 Participants0-
SBP, 1 min Standing, >180 mmHgn=6 Participants0-
SBP, 3 min Standing, <85 mmHgn=6 Participants0-
SBP, 3 min Standing, >180 mmHgn=6 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=6 Participants0-
DBP, Supine, >110 mmHgn=6 Participants0-
DBP, 5 min supine, <50 mmHgn=6 Participants0-
DBP, 5 min Supine, >110 mmHgn=6 Participants0-
DBP, 1 min Standing, <50 mmHgn=6 Participants0-
DBP, 1 min Standing, >110 mmHgn=6 Participants0-
DBP, 3 min Standing, <50 mmHgn=6 Participants0-
DBP, 3 min Standing, >110 mmHgn=6 Participants0-
Pulse, Supine, <50 beats/min (bpm)n=6 Participants0-
Pulse, Supine, >120 beats/minn=6 Participants0-
Pulse, 5 min Supine, <50 beats/minn=6 Participants16.7-
Pulse, 5 min Supine, >120 beats/minn=6 Participants0-
Pulse, 1 min Standing, <50 beats/minn=6 Participants0-
Pulse, 1 min Standing, >120 beats/minn=6 Participants0-
Pulse, 3 min Standing, <50 beats/minn=6 Participants0-
Pulse, 3 min Standing, >120 beats/minn=6 Participants0-
Temperature, <35.6 Celsius (C)n=6 Participants16.7-
Temperature, >37.7 Cn=6 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=6 Participants0-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=6 Participants0-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=6 Participants100-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=6 Participants100-
SRD: Cohort 3: TAK-071 9 mgSystolic Blood Pressure (SBP), Supine, <85 mmHgn=6 Participants0-
SBP, Supine, >180 mmHgn=6 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=6 Participants0-
SBP, 5 min Supine, >180 mmHgn=6 Participants0-
SBP, 1 min Standing, <85 mmHgn=6 Participants0-
SBP, 1 min Standing, >180 mmHgn=6 Participants0-
SBP, 3 min Standing, <85 mmHgn=6 Participants0-
SBP, 3 min Standing, >180 mmHgn=6 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=6 Participants0-
DBP, Supine, >110 mmHgn=6 Participants0-
DBP, 5 min supine, <50 mmHgn=6 Participants0-
DBP, 5 min Supine, >110 mmHgn=6 Participants0-
DBP, 1 min Standing, <50 mmHgn=6 Participants0-
DBP, 1 min Standing, >110 mmHgn=6 Participants0-
DBP, 3 min Standing, <50 mmHgn=6 Participants0-
DBP, 3 min Standing, >110 mmHgn=6 Participants0-
Pulse, Supine, <50 beats/min (bpm)n=6 Participants0-
Pulse, Supine, >120 beats/minn=6 Participants0-
Pulse, 5 min Supine, <50 beats/minn=6 Participants0-
Pulse, 5 min Supine, >120 beats/minn=6 Participants0-
Pulse, 1 min Standing, <50 beats/minn=6 Participants0-
Pulse, 1 min Standing, >120 beats/minn=6 Participants0-
Pulse, 3 min Standing, <50 beats/minn=6 Participants0-
Pulse, 3 min Standing, >120 beats/minn=6 Participants0-
Temperature, <35.6 Celsius (C)n=6 Participants0-
Temperature, >37.7 Cn=6 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=6 Participants0-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=6 Participants0-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=6 Participants0-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=6 Participants0-
SRD: Cohort 4: TAK-071 20 mgSystolic Blood Pressure (SBP), Supine, <85 mmHgn=6 Participants0-
SBP, Supine, >180 mmHgn=6 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=6 Participants0-
SBP, 5 min Supine, >180 mmHgn=6 Participants0-
SBP, 1 min Standing, <85 mmHgn=6 Participants16.7-
SBP, 1 min Standing, >180 mmHgn=6 Participants0-
SBP, 3 min Standing, <85 mmHgn=6 Participants0-
SBP, 3 min Standing, >180 mmHgn=6 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=6 Participants0-
DBP, Supine, >110 mmHgn=6 Participants0-
DBP, 5 min supine, <50 mmHgn=6 Participants0-
DBP, 5 min Supine, >110 mmHgn=6 Participants0-
DBP, 1 min Standing, <50 mmHgn=6 Participants0-
DBP, 1 min Standing, >110 mmHgn=6 Participants0-
DBP, 3 min Standing, <50 mmHgn=6 Participants0-
DBP, 3 min Standing, >110 mmHgn=6 Participants0-
Pulse, Supine, <50 beats/min (bpm)n=6 Participants0-
Pulse, Supine, >120 beats/minn=6 Participants0-
Pulse, 5 min Supine, <50 beats/minn=6 Participants33.3-
Pulse, 5 min Supine, >120 beats/minn=6 Participants0-
Pulse, 1 min Standing, <50 beats/minn=6 Participants0-
Pulse, 1 min Standing, >120 beats/minn=6 Participants0-
Pulse, 3 min Standing, <50 beats/minn=6 Participants0-
Pulse, 3 min Standing, >120 beats/minn=6 Participants0-
Temperature, <35.6 Celsius (C)n=6 Participants0-
Temperature, >37.7 Cn=6 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=6 Participants16.7-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=6 Participants0-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=6 Participants100-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=6 Participants100-
SRD: Cohort 5: TAK-071 40 mgSystolic Blood Pressure (SBP), Supine, <85 mmHgn=6 Participants0-
SBP, Supine, >180 mmHgn=6 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=6 Participants0-
SBP, 5 min Supine, >180 mmHgn=6 Participants0-
SBP, 1 min Standing, <85 mmHgn=6 Participants0-
SBP, 1 min Standing, >180 mmHgn=6 Participants0-
SBP, 3 min Standing, <85 mmHgn=6 Participants0-
SBP, 3 min Standing, >180 mmHgn=6 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=6 Participants0-
DBP, Supine, >110 mmHgn=6 Participants0-
DBP, 5 min supine, <50 mmHgn=6 Participants0-
DBP, 5 min Supine, >110 mmHgn=6 Participants0-
DBP, 1 min Standing, <50 mmHgn=6 Participants0-
DBP, 1 min Standing, >110 mmHgn=6 Participants0-
DBP, 3 min Standing, <50 mmHgn=6 Participants0-
DBP, 3 min Standing, >110 mmHgn=6 Participants0-
Pulse, Supine, <50 beats/min (bpm)n=6 Participants16.7-
Pulse, Supine, >120 beats/minn=6 Participants0-
Pulse, 5 min Supine, <50 beats/minn=6 Participants16.7-
Pulse, 5 min Supine, >120 beats/minn=6 Participants0-
Pulse, 1 min Standing, <50 beats/minn=6 Participants16.7-
Pulse, 1 min Standing, >120 beats/minn=6 Participants0-
Pulse, 3 min Standing, <50 beats/minn=6 Participants0-
Pulse, 3 min Standing, >120 beats/minn=6 Participants0-
Temperature, <35.6 Celsius (C)n=6 Participants0-
Temperature, >37.7 Cn=6 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=6 Participants16.7-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=6 Participants0-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=6 Participants100-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=6 Participants100-
SRD: Cohort 6: TAK-071 80 mgSystolic Blood Pressure (SBP), Supine, <85 mmHgn=6 Participants0-
SBP, Supine, >180 mmHgn=6 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=6 Participants0-
SBP, 5 min Supine, >180 mmHgn=6 Participants0-
SBP, 1 min Standing, <85 mmHgn=6 Participants0-
SBP, 1 min Standing, >180 mmHgn=6 Participants0-
SBP, 3 min Standing, <85 mmHgn=6 Participants16.7-
SBP, 3 min Standing, >180 mmHgn=6 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=6 Participants0-
DBP, Supine, >110 mmHgn=6 Participants0-
DBP, 5 min supine, <50 mmHgn=6 Participants0-
DBP, 5 min Supine, >110 mmHgn=6 Participants0-
DBP, 1 min Standing, <50 mmHgn=6 Participants0-
DBP, 1 min Standing, >110 mmHgn=6 Participants0-
DBP, 3 min Standing, <50 mmHgn=6 Participants0-
DBP, 3 min Standing, >110 mmHgn=6 Participants0-
Pulse, Supine, <50 beats/min (bpm)n=6 Participants16.7-
Pulse, Supine, >120 beats/minn=6 Participants0-
Pulse, 5 min Supine, <50 beats/minn=6 Participants16.7-
Pulse, 5 min Supine, >120 beats/minn=6 Participants0-
Pulse, 1 min Standing, <50 beats/minn=6 Participants0-
Pulse, 1 min Standing, >120 beats/minn=6 Participants0-
Pulse, 3 min Standing, <50 beats/minn=6 Participants0-
Pulse, 3 min Standing, >120 beats/minn=6 Participants0-
Temperature, <35.6 Celsius (C)n=6 Participants33.3-
Temperature, >37.7 Cn=6 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=6 Participants0-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=6 Participants33.3-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=6 Participants100-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=6 Participants100-
MRD: Placebo Cohorts 7-9Systolic Blood Pressure (SBP), Supine, <85 mmHgn=6 Participants0-
SBP, Supine, >180 mmHgn=6 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=6 Participants0-
SBP, 5 min Supine, >180 mmHgn=6 Participants0-
SBP, 1 min Standing, <85 mmHgn=6 Participants0-
SBP, 1 min Standing, >180 mmHgn=6 Participants0-
SBP, 3 min Standing, <85 mmHgn=6 Participants0-
SBP, 3 min Standing, >180 mmHgn=6 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=6 Participants16.7-
DBP, Supine, >110 mmHgn=6 Participants0-
DBP, 5 min supine, <50 mmHgn=6 Participants0-
DBP, 5 min Supine, >110 mmHgn=6 Participants0-
DBP, 1 min Standing, <50 mmHgn=6 Participants0-
DBP, 1 min Standing, >110 mmHgn=6 Participants0-
DBP, 3 min Standing, <50 mmHgn=6 Participants0-
DBP, 3 min Standing, >110 mmHgn=6 Participants0-
Pulse, Supine, <50 beats/min (bpm)n=6 Participants16.7-
Pulse, Supine, >120 beats/minn=6 Participants0-
Pulse, 5 min Supine, <50 beats/minn=6 Participants33.3-
Pulse, 5 min Supine, >120 beats/minn=6 Participants0-
Pulse, 1 min Standing, <50 beats/minn=6 Participants0-
Pulse, 1 min Standing, >120 beats/minn=6 Participants0-
Pulse, 3 min Standing, <50 beats/minn=6 Participants0-
Pulse, 3 min Standing, >120 beats/minn=6 Participants0-
Temperature, <35.6 Celsius (C)n=6 Participants50.0-
Temperature, >37.7 Cn=6 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=6 Participants16.7-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=6 Participants16.7-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=6 Participants66.7-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=6 Participants66.7-
MRD: Cohort 7: TAK-071 3 mgSystolic Blood Pressure (SBP), Supine, <85 mmHgn=6 Participants0-
SBP, Supine, >180 mmHgn=6 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=6 Participants0-
SBP, 5 min Supine, >180 mmHgn=6 Participants0-
SBP, 1 min Standing, <85 mmHgn=6 Participants16.7-
SBP, 1 min Standing, >180 mmHgn=6 Participants0-
SBP, 3 min Standing, <85 mmHgn=6 Participants0-
SBP, 3 min Standing, >180 mmHgn=6 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=6 Participants0-
DBP, Supine, >110 mmHgn=6 Participants0-
DBP, 5 min supine, <50 mmHgn=6 Participants0-
DBP, 5 min Supine, >110 mmHgn=6 Participants0-
DBP, 1 min Standing, <50 mmHgn=6 Participants0-
DBP, 1 min Standing, >110 mmHgn=6 Participants0-
DBP, 3 min Standing, <50 mmHgn=6 Participants0-
DBP, 3 min Standing, >110 mmHgn=6 Participants0-
Pulse, Supine, <50 beats/min (bpm)n=6 Participants0-
Pulse, Supine, >120 beats/minn=6 Participants0-
Pulse, 5 min Supine, <50 beats/minn=6 Participants0-
Pulse, 5 min Supine, >120 beats/minn=6 Participants0-
Pulse, 1 min Standing, <50 beats/minn=6 Participants0-
Pulse, 1 min Standing, >120 beats/minn=6 Participants0-
Pulse, 3 min Standing, <50 beats/minn=6 Participants0-
Pulse, 3 min Standing, >120 beats/minn=6 Participants0-
Temperature, <35.6 Celsius (C)n=6 Participants16.7-
Temperature, >37.7 Cn=6 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=6 Participants16.7-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=6 Participants0-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=6 Participants16.7-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=6 Participants100-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=6 Participants100-
MRD: Cohort 8: TAK-071 9 mgSystolic Blood Pressure (SBP), Supine, <85 mmHgn=6 Participants16.7-
SBP, Supine, >180 mmHgn=6 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=6 Participants16.7-
SBP, 5 min Supine, >180 mmHgn=6 Participants0-
SBP, 1 min Standing, <85 mmHgn=6 Participants16.7-
SBP, 1 min Standing, >180 mmHgn=6 Participants0-
SBP, 3 min Standing, <85 mmHgn=6 Participants16.7-
SBP, 3 min Standing, >180 mmHgn=6 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=6 Participants0-
DBP, Supine, >110 mmHgn=6 Participants0-
DBP, 5 min supine, <50 mmHgn=6 Participants16.7-
DBP, 5 min Supine, >110 mmHgn=6 Participants0-
DBP, 1 min Standing, <50 mmHgn=6 Participants0-
DBP, 1 min Standing, >110 mmHgn=6 Participants0-
DBP, 3 min Standing, <50 mmHgn=6 Participants0-
DBP, 3 min Standing, >110 mmHgn=6 Participants0-
Pulse, Supine, <50 beats/min (bpm)n=6 Participants16.7-
Pulse, Supine, >120 beats/minn=6 Participants0-
Pulse, 5 min Supine, <50 beats/minn=6 Participants33.3-
Pulse, 5 min Supine, >120 beats/minn=6 Participants0-
Pulse, 1 min Standing, <50 beats/minn=6 Participants0-
Pulse, 1 min Standing, >120 beats/minn=6 Participants0-
Pulse, 3 min Standing, <50 beats/minn=6 Participants0-
Pulse, 3 min Standing, >120 beats/minn=6 Participants0-
Temperature, <35.6 Celsius (C)n=6 Participants33.3-
Temperature, >37.7 Cn=6 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=6 Participants0-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=6 Participants33.3-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=6 Participants16.7-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=6 Participants100-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=6 Participants100-
MRD: Cohort 9: TAK-071 15 mgSystolic Blood Pressure (SBP), Supine, <85 mmHgn=6 Participants0-
SBP, Supine, >180 mmHgn=6 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=6 Participants0-
SBP, 5 min Supine, >180 mmHgn=6 Participants0-
SBP, 1 min Standing, <85 mmHgn=6 Participants0-
SBP, 1 min Standing, >180 mmHgn=6 Participants0-
SBP, 3 min Standing, <85 mmHgn=6 Participants0-
SBP, 3 min Standing, >180 mmHgn=6 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=6 Participants0-
DBP, Supine, >110 mmHgn=6 Participants0-
DBP, 5 min supine, <50 mmHgn=6 Participants0-
DBP, 5 min Supine, >110 mmHgn=6 Participants0-
DBP, 1 min Standing, <50 mmHgn=6 Participants0-
DBP, 1 min Standing, >110 mmHgn=6 Participants0-
DBP, 3 min Standing, <50 mmHgn=6 Participants0-
DBP, 3 min Standing, >110 mmHgn=6 Participants0-
Pulse, Supine, <50 beats/min (bpm)n=6 Participants0-
Pulse, Supine, >120 beats/minn=6 Participants0-
Pulse, 5 min Supine, <50 beats/minn=6 Participants0-
Pulse, 5 min Supine, >120 beats/minn=6 Participants0-
Pulse, 1 min Standing, <50 beats/minn=6 Participants0-
Pulse, 1 min Standing, >120 beats/minn=6 Participants0-
Pulse, 3 min Standing, <50 beats/minn=6 Participants0-
Pulse, 3 min Standing, >120 beats/minn=6 Participants0-
Temperature, <35.6 Celsius (C)n=6 Participants16.7-
Temperature, >37.7 Cn=6 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=6 Participants0-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=6 Participants0-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=6 Participants0-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=6 Participants0-
MRD: TAK-071 Placebo Cohorts 10-12+DonepezilSystolic Blood Pressure (SBP), Supine, <85 mmHgn=6 Participants0-
SBP, Supine, >180 mmHgn=6 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=6 Participants0-
SBP, 5 min Supine, >180 mmHgn=6 Participants0-
SBP, 1 min Standing, <85 mmHgn=6 Participants0-
SBP, 1 min Standing, >180 mmHgn=6 Participants0-
SBP, 3 min Standing, <85 mmHgn=6 Participants0-
SBP, 3 min Standing, >180 mmHgn=6 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=6 Participants0-
DBP, Supine, >110 mmHgn=6 Participants0-
DBP, 5 min supine, <50 mmHgn=6 Participants0-
DBP, 5 min Supine, >110 mmHgn=6 Participants0-
DBP, 1 min Standing, <50 mmHgn=6 Participants0-
DBP, 1 min Standing, >110 mmHgn=6 Participants0-
DBP, 3 min Standing, <50 mmHgn=6 Participants0-
DBP, 3 min Standing, >110 mmHgn=6 Participants0-
Pulse, Supine, <50 beats/min (bpm)n=6 Participants0-
Pulse, Supine, >120 beats/minn=6 Participants0-
Pulse, 5 min Supine, <50 beats/minn=6 Participants16.7-
Pulse, 5 min Supine, >120 beats/minn=6 Participants0-
Pulse, 1 min Standing, <50 beats/minn=6 Participants0-
Pulse, 1 min Standing, >120 beats/minn=6 Participants16.7-
Pulse, 3 min Standing, <50 beats/minn=6 Participants0-
Pulse, 3 min Standing, >120 beats/minn=6 Participants0-
Temperature, <35.6 Celsius (C)n=6 Participants16.7-
Temperature, >37.7 Cn=6 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=6 Participants50.0-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=6 Participants16.7-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=6 Participants100-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=6 Participants100-
MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mgSystolic Blood Pressure (SBP), Supine, <85 mmHgn=6 Participants0-
SBP, Supine, >180 mmHgn=6 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=6 Participants0-
SBP, 5 min Supine, >180 mmHgn=6 Participants0-
SBP, 1 min Standing, <85 mmHgn=6 Participants16.7-
SBP, 1 min Standing, >180 mmHgn=6 Participants0-
SBP, 3 min Standing, <85 mmHgn=6 Participants16.7-
SBP, 3 min Standing, >180 mmHgn=6 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=6 Participants0-
DBP, Supine, >110 mmHgn=6 Participants0-
DBP, 5 min supine, <50 mmHgn=6 Participants0-
DBP, 5 min Supine, >110 mmHgn=6 Participants0-
DBP, 1 min Standing, <50 mmHgn=6 Participants16.7-
DBP, 1 min Standing, >110 mmHgn=6 Participants0-
DBP, 3 min Standing, <50 mmHgn=6 Participants0-
DBP, 3 min Standing, >110 mmHgn=6 Participants0-
Pulse, Supine, <50 beats/min (bpm)n=6 Participants33.3-
Pulse, Supine, >120 beats/minn=6 Participants0-
Pulse, 5 min Supine, <50 beats/minn=6 Participants33.3-
Pulse, 5 min Supine, >120 beats/minn=6 Participants0-
Pulse, 1 min Standing, <50 beats/minn=6 Participants0-
Pulse, 1 min Standing, >120 beats/minn=6 Participants16.7-
Pulse, 3 min Standing, <50 beats/minn=6 Participants0-
Pulse, 3 min Standing, >120 beats/minn=6 Participants16.7-
Temperature, <35.6 Celsius (C)n=6 Participants33.3-
Temperature, >37.7 Cn=6 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=6 Participants50.0-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=6 Participants33.3-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=6 Participants16.7-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=6 Participants16.7-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=6 Participants100-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=6 Participants100-
MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mgSystolic Blood Pressure (SBP), Supine, <85 mmHgn=6 Participants0-
SBP, Supine, >180 mmHgn=6 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=6 Participants16.7-
SBP, 5 min Supine, >180 mmHgn=6 Participants0-
SBP, 1 min Standing, <85 mmHgn=6 Participants0-
SBP, 1 min Standing, >180 mmHgn=6 Participants0-
SBP, 3 min Standing, <85 mmHgn=6 Participants33.3-
SBP, 3 min Standing, >180 mmHgn=6 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=6 Participants0-
DBP, Supine, >110 mmHgn=6 Participants0-
DBP, 5 min supine, <50 mmHgn=6 Participants0-
DBP, 5 min Supine, >110 mmHgn=6 Participants0-
DBP, 1 min Standing, <50 mmHgn=6 Participants0-
DBP, 1 min Standing, >110 mmHgn=6 Participants0-
DBP, 3 min Standing, <50 mmHgn=6 Participants16.7-
DBP, 3 min Standing, >110 mmHgn=6 Participants0-
Pulse, Supine, <50 beats/min (bpm)n=6 Participants50.0-
Pulse, Supine, >120 beats/minn=6 Participants0-
Pulse, 5 min Supine, <50 beats/minn=6 Participants16.7-
Pulse, 5 min Supine, >120 beats/minn=6 Participants0-
Pulse, 1 min Standing, <50 beats/minn=6 Participants0-
Pulse, 1 min Standing, >120 beats/minn=6 Participants0-
Pulse, 3 min Standing, <50 beats/minn=6 Participants0-
Pulse, 3 min Standing, >120 beats/minn=6 Participants0-
Temperature, <35.6 Celsius (C)n=6 Participants0-
Temperature, >37.7 Cn=6 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=6 Participants50.0-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=6 Participants50.0-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=6 Participants33.3-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=6 Participants100-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=6 Participants100-
MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mgSystolic Blood Pressure (SBP), Supine, <85 mmHgn=6 Participants0-
SBP, Supine, >180 mmHgn=6 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=6 Participants0-
SBP, 5 min Supine, >180 mmHgn=6 Participants0-
SBP, 1 min Standing, <85 mmHgn=6 Participants0-
SBP, 1 min Standing, >180 mmHgn=6 Participants0-
SBP, 3 min Standing, <85 mmHgn=6 Participants0-
SBP, 3 min Standing, >180 mmHgn=6 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=6 Participants0-
DBP, Supine, >110 mmHgn=6 Participants0-
DBP, 5 min supine, <50 mmHgn=6 Participants0-
DBP, 5 min Supine, >110 mmHgn=6 Participants0-
DBP, 1 min Standing, <50 mmHgn=6 Participants0-
DBP, 1 min Standing, >110 mmHgn=6 Participants16.7-
DBP, 3 min Standing, <50 mmHgn=6 Participants0-
DBP, 3 min Standing, >110 mmHgn=6 Participants16.7-
Pulse, Supine, <50 beats/min (bpm)n=6 Participants50.0-
Pulse, Supine, >120 beats/minn=6 Participants0-
Pulse, 5 min Supine, <50 beats/minn=6 Participants16.7-
Pulse, 5 min Supine, >120 beats/minn=6 Participants0-
Pulse, 1 min Standing, <50 beats/minn=6 Participants0-
Pulse, 1 min Standing, >120 beats/minn=6 Participants0-
Pulse, 3 min Standing, <50 beats/minn=6 Participants0-
Pulse, 3 min Standing, >120 beats/minn=6 Participants0-
Temperature, <35.6 Celsius (C)n=6 Participants33.3-
Temperature, >37.7 Cn=6 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=6 Participants16.7-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=6 Participants0-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=6 Participants16.7-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=6 Participants100-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=6 Participants100-
MRD: Placebo Cohorts 13-15Systolic Blood Pressure (SBP), Supine, <85 mmHgn=3 Participants0-
SBP, Supine, >180 mmHgn=3 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=3 Participants0-
SBP, 5 min Supine, >180 mmHgn=3 Participants0-
SBP, 1 min Standing, <85 mmHgn=3 Participants0-
SBP, 1 min Standing, >180 mmHgn=3 Participants0-
SBP, 3 min Standing, <85 mmHgn=3 Participants0-
SBP, 3 min Standing, >180 mmHgn=3 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=3 Participants0-
DBP, Supine, >110 mmHgn=3 Participants0-
DBP, 5 min supine, <50 mmHgn=3 Participants0-
DBP, 5 min Supine, >110 mmHgn=3 Participants0-
DBP, 1 min Standing, <50 mmHgn=3 Participants0-
DBP, 1 min Standing, >110 mmHgn=3 Participants0-
DBP, 3 min Standing, <50 mmHgn=3 Participants0-
DBP, 3 min Standing, >110 mmHgn=3 Participants0-
Pulse, Supine, <50 beats/min (bpm)n=3 Participants0-
Pulse, Supine, >120 beats/minn=3 Participants0-
Pulse, 5 min Supine, <50 beats/minn=3 Participants33.3-
Pulse, 5 min Supine, >120 beats/minn=3 Participants0-
Pulse, 1 min Standing, <50 beats/minn=3 Participants0-
Pulse, 1 min Standing, >120 beats/minn=3 Participants0-
Pulse, 3 min Standing, <50 beats/minn=3 Participants0-
Pulse, 3 min Standing, >120 beats/minn=3 Participants0-
Temperature, <35.6 Celsius (C)n=3 Participants66.7-
Temperature, >37.7 Cn=3 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=3 Participants0-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=3 Participants0-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=3 Participants0-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=3 Participants0-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=3 Participants100-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=3 Participants100-
MRD: Cohort 13: TAK-071 3 mgSystolic Blood Pressure (SBP), Supine, <85 mmHgn=5 Participants0-
SBP, Supine, >180 mmHgn=5 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=5 Participants0-
SBP, 5 min Supine, >180 mmHgn=5 Participants0-
SBP, 1 min Standing, <85 mmHgn=5 Participants0-
SBP, 1 min Standing, >180 mmHgn=5 Participants0-
SBP, 3 min Standing, <85 mmHgn=5 Participants0-
SBP, 3 min Standing, >180 mmHgn=5 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=5 Participants0-
DBP, Supine, >110 mmHgn=5 Participants0-
DBP, 5 min supine, <50 mmHgn=5 Participants0-
DBP, 5 min Supine, >110 mmHgn=5 Participants0-
DBP, 1 min Standing, <50 mmHgn=5 Participants0-
DBP, 1 min Standing, >110 mmHgn=5 Participants0-
DBP, 3 min Standing, <50 mmHgn=5 Participants0-
DBP, 3 min Standing, >110 mmHgn=5 Participants0-
Pulse, Supine, <50 beats/min (bpm)n=5 Participants0-
Pulse, Supine, >120 beats/minn=5 Participants0-
Pulse, 5 min Supine, <50 beats/minn=5 Participants60.0-
Pulse, 5 min Supine, >120 beats/minn=5 Participants0-
Pulse, 1 min Standing, <50 beats/minn=5 Participants0-
Pulse, 1 min Standing, >120 beats/minn=5 Participants0-
Pulse, 3 min Standing, <50 beats/minn=5 Participants0-
Pulse, 3 min Standing, >120 beats/minn=5 Participants0-
Temperature, <35.6 Celsius (C)n=5 Participants40.0-
Temperature, >37.7 Cn=5 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=5 Participants20.0-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=5 Participants20.0-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=5 Participants0-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=5 Participants0-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=5 Participants100-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=5 Participants100-
MRD: Cohort 14: TAK-071 9 mgSystolic Blood Pressure (SBP), Supine, <85 mmHgn=5 Participants0-
SBP, Supine, >180 mmHgn=5 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=5 Participants0-
SBP, 5 min Supine, >180 mmHgn=5 Participants0-
SBP, 1 min Standing, <85 mmHgn=5 Participants0-
SBP, 1 min Standing, >180 mmHgn=5 Participants0-
SBP, 3 min Standing, <85 mmHgn=5 Participants0-
SBP, 3 min Standing, >180 mmHgn=5 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=5 Participants0-
DBP, Supine, >110 mmHgn=5 Participants0-
DBP, 5 min supine, <50 mmHgn=5 Participants0-
DBP, 5 min Supine, >110 mmHgn=5 Participants0-
DBP, 1 min Standing, <50 mmHgn=5 Participants0-
DBP, 1 min Standing, >110 mmHgn=5 Participants0-
DBP, 3 min Standing, <50 mmHgn=5 Participants0-
DBP, 3 min Standing, >110 mmHgn=5 Participants20.0-
Pulse, Supine, <50 beats/min (bpm)n=5 Participants0-
Pulse, Supine, >120 beats/minn=5 Participants0-
Pulse, 5 min Supine, <50 beats/minn=5 Participants40.0-
Pulse, 5 min Supine, >120 beats/minn=5 Participants0-
Pulse, 1 min Standing, <50 beats/minn=5 Participants20.0-
Pulse, 1 min Standing, >120 beats/minn=5 Participants20.0-
Pulse, 3 min Standing, <50 beats/minn=5 Participants20.0-
Pulse, 3 min Standing, >120 beats/minn=5 Participants0-
Temperature, <35.6 Celsius (C)n=5 Participants20.0-
Temperature, >37.7 Cn=5 Participants20.0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=5 Participants40.0-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=5 Participants40.0-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=5 Participants0-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=5 Participants20.0-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=5 Participants100-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=5 Participants100-
MRD: Cohort 15: TAK-071 15 mgSystolic Blood Pressure (SBP), Supine, <85 mmHgn=5 Participants0-
SBP, Supine, >180 mmHgn=5 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=5 Participants0-
SBP, 5 min Supine, >180 mmHgn=5 Participants0-
SBP, 1 min Standing, <85 mmHgn=5 Participants20.0-
SBP, 1 min Standing, >180 mmHgn=5 Participants0-
SBP, 3 min Standing, <85 mmHgn=5 Participants20.0-
SBP, 3 min Standing, >180 mmHgn=5 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=5 Participants0-
DBP, Supine, >110 mmHgn=5 Participants0-
DBP, 5 min supine, <50 mmHgn=5 Participants0-
DBP, 5 min Supine, >110 mmHgn=5 Participants0-
DBP, 1 min Standing, <50 mmHgn=5 Participants0-
DBP, 1 min Standing, >110 mmHgn=5 Participants20.0-
DBP, 3 min Standing, <50 mmHgn=5 Participants0-
DBP, 3 min Standing, >110 mmHgn=5 Participants0-
Pulse, Supine, <50 beats/min (bpm)n=5 Participants0-
Pulse, Supine, >120 beats/minn=5 Participants0-
Pulse, 5 min Supine, <50 beats/minn=5 Participants20.0-
Pulse, 5 min Supine, >120 beats/minn=5 Participants20.0-
Pulse, 1 min Standing, <50 beats/minn=5 Participants0-
Pulse, 1 min Standing, >120 beats/minn=5 Participants40.0-
Pulse, 3 min Standing, <50 beats/minn=5 Participants0-
Pulse, 3 min Standing, >120 beats/minn=5 Participants40.0-
Temperature, <35.6 Celsius (C)n=5 Participants60.0-
Temperature, >37.7 Cn=5 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=5 Participants60.0-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=5 Participants40.0-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=5 Participants20.0-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=5 Participants20.0-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=5 Participants100-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=5 Participants100-
Bioavailability (BA)/Food Effect: Cohort 17 Regimen ASystolic Blood Pressure (SBP), Supine, <85 mmHgn=12 Participants0-
SBP, Supine, >180 mmHgn=12 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=12 Participants0-
SBP, 5 min Supine, >180 mmHgn=12 Participants0-
SBP, 1 min Standing, <85 mmHgn=12 Participants8.3-
SBP, 1 min Standing, >180 mmHgn=12 Participants0-
SBP, 3 min Standing, <85 mmHgn=12 Participants8.3-
SBP, 3 min Standing, >180 mmHgn=12 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=12 Participants0-
DBP, Supine, >110 mmHgn=12 Participants0-
DBP, 5 min supine, <50 mmHgn=12 Participants0-
DBP, 5 min Supine, >110 mmHgn=12 Participants0-
DBP, 1 min Standing, <50 mmHgn=12 Participants8.3-
DBP, 1 min Standing, >110 mmHgn=12 Participants0-
DBP, 3 min Standing, <50 mmHgn=12 Participants0-
DBP, 3 min Standing, >110 mmHgn=12 Participants0-
Pulse, Supine, <50 beats/min (bpm)n=12 Participants16.7-
Pulse, Supine, >120 beats/minn=12 Participants0-
Pulse, 5 min Supine, <50 beats/minn=12 Participants33.3-
Pulse, 5 min Supine, >120 beats/minn=12 Participants0-
Pulse, 1 min Standing, <50 beats/minn=12 Participants0-
Pulse, 1 min Standing, >120 beats/minn=12 Participants0-
Pulse, 3 min Standing, <50 beats/minn=12 Participants0-
Pulse, 3 min Standing, >120 beats/minn=12 Participants0-
Temperature, <35.6 Celsius (C)n=12 Participants25.0-
Temperature, >37.7 Cn=12 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=12 Participants16.7-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=12 Participants16.7-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=12 Participants8.3-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=12 Participants8.3-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=12 Participants100-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=12 Participants100-
BA/Food Effect: Cohort 17 Regimen BSystolic Blood Pressure (SBP), Supine, <85 mmHgn=12 Participants0-
SBP, Supine, >180 mmHgn=12 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=12 Participants0-
SBP, 5 min Supine, >180 mmHgn=12 Participants0-
SBP, 1 min Standing, <85 mmHgn=12 Participants8.3-
SBP, 1 min Standing, >180 mmHgn=12 Participants0-
SBP, 3 min Standing, <85 mmHgn=12 Participants8.3-
SBP, 3 min Standing, >180 mmHgn=12 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=12 Participants0-
DBP, Supine, >110 mmHgn=12 Participants0-
DBP, 5 min supine, <50 mmHgn=12 Participants8.3-
DBP, 5 min Supine, >110 mmHgn=12 Participants0-
DBP, 1 min Standing, <50 mmHgn=12 Participants8.3-
DBP, 1 min Standing, >110 mmHgn=12 Participants0-
DBP, 3 min Standing, <50 mmHgn=12 Participants0-
DBP, 3 min Standing, >110 mmHgn=12 Participants0-
Pulse, Supine, <50 beats/min (bpm)n=12 Participants16.7-
Pulse, Supine, >120 beats/minn=12 Participants0-
Pulse, 5 min Supine, <50 beats/minn=12 Participants41.7-
Pulse, 5 min Supine, >120 beats/minn=12 Participants0-
Pulse, 1 min Standing, <50 beats/minn=12 Participants0-
Pulse, 1 min Standing, >120 beats/minn=12 Participants0-
Pulse, 3 min Standing, <50 beats/minn=12 Participants0-
Pulse, 3 min Standing, >120 beats/minn=12 Participants0-
Temperature, <35.6 Celsius (C)n=12 Participants0-
Temperature, >37.7 Cn=12 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=12 Participants0-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=12 Participants8.3-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=12 Participants0-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=12 Participants0-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=12 Participants100-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=12 Participants100-
BA/Food Effect: Cohort 17 Regimen CSystolic Blood Pressure (SBP), Supine, <85 mmHgn=12 Participants0-
SBP, Supine, >180 mmHgn=12 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=12 Participants8.3-
SBP, 5 min Supine, >180 mmHgn=12 Participants0-
SBP, 1 min Standing, <85 mmHgn=12 Participants0-
SBP, 1 min Standing, >180 mmHgn=12 Participants0-
SBP, 3 min Standing, <85 mmHgn=12 Participants0-
SBP, 3 min Standing, >180 mmHgn=12 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=12 Participants0-
DBP, Supine, >110 mmHgn=12 Participants0-
DBP, 5 min supine, <50 mmHgn=12 Participants0-
DBP, 5 min Supine, >110 mmHgn=12 Participants0-
DBP, 1 min Standing, <50 mmHgn=12 Participants0-
DBP, 1 min Standing, >110 mmHgn=12 Participants0-
DBP, 3 min Standing, <50 mmHgn=12 Participants0-
DBP, 3 min Standing, >110 mmHgn=12 Participants0-
Pulse, Supine, <50 beats/min (bpm)n=12 Participants0-
Pulse, Supine, >120 beats/minn=12 Participants0-
Pulse, 5 min Supine, <50 beats/minn=12 Participants25.0-
Pulse, 5 min Supine, >120 beats/minn=12 Participants0-
Pulse, 1 min Standing, <50 beats/minn=12 Participants0-
Pulse, 1 min Standing, >120 beats/minn=12 Participants0-
Pulse, 3 min Standing, <50 beats/minn=12 Participants0-
Pulse, 3 min Standing, >120 beats/minn=12 Participants0-
Temperature, <35.6 Celsius (C)n=12 Participants8.3-
Temperature, >37.7 Cn=12 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=12 Participants8.3-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=12 Participants0-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=12 Participants0-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=12 Participants0-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=12 Participants100-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=12 Participants100-
SRD: Cohort 18: TAK-071 120 mgSystolic Blood Pressure (SBP), Supine, <85 mmHgn=6 Participants0-
SBP, Supine, >180 mmHgn=6 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=6 Participants0-
SBP, 5 min Supine, >180 mmHgn=6 Participants0-
SBP, 1 min Standing, <85 mmHgn=6 Participants16.7-
SBP, 1 min Standing, >180 mmHgn=6 Participants0-
SBP, 3 min Standing, <85 mmHgn=6 Participants0-
SBP, 3 min Standing, >180 mmHgn=6 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=6 Participants0-
DBP, Supine, >110 mmHgn=6 Participants0-
DBP, 5 min supine, <50 mmHgn=6 Participants0-
DBP, 5 min Supine, >110 mmHgn=6 Participants0-
DBP, 1 min Standing, <50 mmHgn=6 Participants0-
DBP, 1 min Standing, >110 mmHgn=6 Participants0-
DBP, 3 min Standing, <50 mmHgn=6 Participants0-
DBP, 3 min Standing, >110 mmHgn=6 Participants0-
Pulse, Supine, <50 beats/min (bpm)n=6 Participants0-
Pulse, Supine, >120 beats/minn=6 Participants0-
Pulse, 5 min Supine, <50 beats/minn=6 Participants66.7-
Pulse, 5 min Supine, >120 beats/minn=6 Participants0-
Pulse, 1 min Standing, <50 beats/minn=6 Participants0-
Pulse, 1 min Standing, >120 beats/minn=6 Participants0-
Pulse, 3 min Standing, <50 beats/minn=6 Participants0-
Pulse, 3 min Standing, >120 beats/minn=6 Participants0-
Temperature, <35.6 Celsius (C)n=6 Participants0-
Temperature, >37.7 Cn=6 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=6 Participants33.3-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=6 Participants16.7-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=6 Participants16.7-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=6 Participants16.7-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=6 Participants100-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=6 Participants100-
SRD: Cohort 19: TAK-071 160 mgSystolic Blood Pressure (SBP), Supine, <85 mmHgn=6 Participants0-
SBP, Supine, >180 mmHgn=6 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=6 Participants0-
SBP, 5 min Supine, >180 mmHgn=6 Participants0-
SBP, 1 min Standing, <85 mmHgn=6 Participants0-
SBP, 1 min Standing, >180 mmHgn=6 Participants0-
SBP, 3 min Standing, <85 mmHgn=6 Participants16.7-
SBP, 3 min Standing, >180 mmHgn=6 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=6 Participants0-
DBP, Supine, >110 mmHgn=6 Participants0-
DBP, 5 min supine, <50 mmHgn=6 Participants0-
DBP, 5 min Supine, >110 mmHgn=6 Participants0-
DBP, 1 min Standing, <50 mmHgn=6 Participants0-
DBP, 1 min Standing, >110 mmHgn=6 Participants0-
DBP, 3 min Standing, <50 mmHgn=6 Participants0-
DBP, 3 min Standing, >110 mmHgn=6 Participants0-
Pulse, Supine, <50 beats/min (bpm)n=6 Participants0-
Pulse, Supine, >120 beats/minn=6 Participants0-
Pulse, 5 min Supine, <50 beats/minn=6 Participants0-
Pulse, 5 min Supine, >120 beats/minn=6 Participants0-
Pulse, 1 min Standing, <50 beats/minn=6 Participants0-
Pulse, 1 min Standing, >120 beats/minn=6 Participants16.7-
Pulse, 3 min Standing, <50 beats/minn=6 Participants0-
Pulse, 3 min Standing, >120 beats/minn=6 Participants0-
Temperature, <35.6 Celsius (C)n=6 Participants0-
Temperature, >37.7 Cn=6 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=6 Participants16.7-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=6 Participants16.7-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=6 Participants100-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=6 Participants100-
SRD: TAK-071 Placebo+Donepezil PlaceboSystolic Blood Pressure (SBP), Supine, <85 mmHgn=9 Participants0-
SBP, Supine, >180 mmHgn=9 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=9 Participants0-
SBP, 5 min Supine, >180 mmHgn=9 Participants0-
SBP, 1 min Standing, <85 mmHgn=9 Participants0-
SBP, 1 min Standing, >180 mmHgn=9 Participants0-
SBP, 3 min Standing, <85 mmHgn=9 Participants0-
SBP, 3 min Standing, >180 mmHgn=9 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=9 Participants0-
DBP, Supine, >110 mmHgn=9 Participants0-
DBP, 5 min supine, <50 mmHgn=9 Participants0-
DBP, 5 min Supine, >110 mmHgn=9 Participants0-
DBP, 1 min Standing, <50 mmHgn=9 Participants0-
DBP, 1 min Standing, >110 mmHgn=9 Participants0-
DBP, 3 min Standing, <50 mmHgn=9 Participants0-
DBP, 3 min Standing, >110 mmHgn=9 Participants0-
Pulse, Supine, <50 beats/min (bpm)n=9 Participants0-
Pulse, Supine, >120 beats/minn=9 Participants0-
Pulse, 5 min Supine, <50 beats/minn=9 Participants44.4-
Pulse, 5 min Supine, >120 beats/minn=9 Participants0-
Pulse, 1 min Standing, <50 beats/minn=9 Participants0-
Pulse, 1 min Standing, >120 beats/minn=9 Participants11.1-
Pulse, 3 min Standing, <50 beats/minn=9 Participants0-
Pulse, 3 min Standing, >120 beats/minn=9 Participants0-
Temperature, <35.6 Celsius (C)n=9 Participants0-
Temperature, >37.7 Cn=9 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=9 Participants22.2-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=9 Participants0-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=9 Participants0-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=9 Participants0-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=9 Participants88.9-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=9 Participants88.9-
SRD: TAK-071 Placebo+DonepezilSystolic Blood Pressure (SBP), Supine, <85 mmHgn=9 Participants0-
SBP, Supine, >180 mmHgn=9 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=9 Participants0-
SBP, 5 min Supine, >180 mmHgn=9 Participants0-
SBP, 1 min Standing, <85 mmHgn=9 Participants11.1-
SBP, 1 min Standing, >180 mmHgn=9 Participants0-
SBP, 3 min Standing, <85 mmHgn=9 Participants11.1-
SBP, 3 min Standing, >180 mmHgn=9 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=9 Participants0-
DBP, Supine, >110 mmHgn=9 Participants0-
DBP, 5 min supine, <50 mmHgn=9 Participants11.1-
DBP, 5 min Supine, >110 mmHgn=9 Participants0-
DBP, 1 min Standing, <50 mmHgn=9 Participants0-
DBP, 1 min Standing, >110 mmHgn=9 Participants0-
DBP, 3 min Standing, <50 mmHgn=9 Participants11.1-
DBP, 3 min Standing, >110 mmHgn=9 Participants0-
Pulse, Supine, <50 beats/min (bpm)n=9 Participants0-
Pulse, Supine, >120 beats/minn=9 Participants0-
Pulse, 5 min Supine, <50 beats/minn=9 Participants22.2-
Pulse, 5 min Supine, >120 beats/minn=9 Participants0-
Pulse, 1 min Standing, <50 beats/minn=9 Participants0-
Pulse, 1 min Standing, >120 beats/minn=9 Participants0-
Pulse, 3 min Standing, <50 beats/minn=9 Participants0-
Pulse, 3 min Standing, >120 beats/minn=9 Participants0-
Temperature, <35.6 Celsius (C)n=9 Participants0-
Temperature, >37.7 Cn=9 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=9 Participants0-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=9 Participants0-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=9 Participants0-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=9 Participants0-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=9 Participants100-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=9 Participants100-
SRD: Cohort 20: TAK-071 40 mg+DonepezilSystolic Blood Pressure (SBP), Supine, <85 mmHgn=5 Participants0-
SBP, Supine, >180 mmHgn=5 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=5 Participants0-
SBP, 5 min Supine, >180 mmHgn=5 Participants0-
SBP, 1 min Standing, <85 mmHgn=5 Participants0-
SBP, 1 min Standing, >180 mmHgn=5 Participants0-
SBP, 3 min Standing, <85 mmHgn=5 Participants0-
SBP, 3 min Standing, >180 mmHgn=5 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=5 Participants0-
DBP, Supine, >110 mmHgn=5 Participants0-
DBP, 5 min supine, <50 mmHgn=5 Participants0-
DBP, 5 min Supine, >110 mmHgn=5 Participants0-
DBP, 1 min Standing, <50 mmHgn=5 Participants0-
DBP, 1 min Standing, >110 mmHgn=5 Participants0-
DBP, 3 min Standing, <50 mmHgn=5 Participants0-
DBP, 3 min Standing, >110 mmHgn=5 Participants0-
Pulse, Supine, <50 beats/min (bpm)n=5 Participants0-
Pulse, Supine, >120 beats/minn=5 Participants0-
Pulse, 5 min Supine, <50 beats/minn=5 Participants40.0-
Pulse, 5 min Supine, >120 beats/minn=5 Participants0-
Pulse, 1 min Standing, <50 beats/minn=5 Participants0-
Pulse, 1 min Standing, >120 beats/minn=5 Participants20.0-
Pulse, 3 min Standing, <50 beats/minn=5 Participants0-
Pulse, 3 min Standing, >120 beats/minn=5 Participants20.0-
Temperature, <35.6 Celsius (C)n=5 Participants40.0-
Temperature, >37.7 Cn=5 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=5 Participants40.0-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=5 Participants40.0-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=5 Participants20.0-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=5 Participants0-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=5 Participants100-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=5 Participants100-
SRD: Cohort 21: TAK-071 60 mg+DonepezilSystolic Blood Pressure (SBP), Supine, <85 mmHgn=6 Participants0-
SBP, Supine, >180 mmHgn=6 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=6 Participants0-
SBP, 5 min Supine, >180 mmHgn=6 Participants0-
SBP, 1 min Standing, <85 mmHgn=6 Participants0-
SBP, 1 min Standing, >180 mmHgn=6 Participants0-
SBP, 3 min Standing, <85 mmHgn=6 Participants0-
SBP, 3 min Standing, >180 mmHgn=6 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=6 Participants0-
DBP, Supine, >110 mmHgn=6 Participants0-
DBP, 5 min supine, <50 mmHgn=6 Participants0-
DBP, 5 min Supine, >110 mmHgn=6 Participants0-
DBP, 1 min Standing, <50 mmHgn=6 Participants0-
DBP, 1 min Standing, >110 mmHgn=6 Participants0-
DBP, 3 min Standing, <50 mmHgn=6 Participants0-
DBP, 3 min Standing, >110 mmHgn=6 Participants0-
Pulse, Supine, <50 beats/min (bpm)n=6 Participants0-
Pulse, Supine, >120 beats/minn=6 Participants0-
Pulse, 5 min Supine, <50 beats/minn=6 Participants33.3-
Pulse, 5 min Supine, >120 beats/minn=6 Participants0-
Pulse, 1 min Standing, <50 beats/minn=6 Participants0-
Pulse, 1 min Standing, >120 beats/minn=6 Participants0-
Pulse, 3 min Standing, <50 beats/minn=6 Participants0-
Pulse, 3 min Standing, >120 beats/minn=6 Participants0-
Temperature, <35.6 Celsius (C)n=6 Participants0-
Temperature, >37.7 Cn=6 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=6 Participants0-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=6 Participants16.7-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=6 Participants100-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=6 Participants100-
SRD: Cohort 22: TAK-071 80 mg+DonepezilSystolic Blood Pressure (SBP), Supine, <85 mmHgn=6 Participants0-
SBP, Supine, >180 mmHgn=6 Participants0-
SBP, 5 minutes (min) Supine, <85 mmHg,n=6 Participants0-
SBP, 5 min Supine, >180 mmHgn=6 Participants0-
SBP, 1 min Standing, <85 mmHgn=6 Participants0-
SBP, 1 min Standing, >180 mmHgn=6 Participants0-
SBP, 3 min Standing, <85 mmHgn=6 Participants0-
SBP, 3 min Standing, >180 mmHgn=6 Participants0-
Diastolic Blood Pressure (DBP), Supine, <50 mmHgn=6 Participants0-
DBP, Supine, >110 mmHgn=6 Participants0-
DBP, 5 min supine, <50 mmHgn=6 Participants0-
DBP, 5 min Supine, >110 mmHgn=6 Participants0-
DBP, 1 min Standing, <50 mmHgn=6 Participants0-
DBP, 1 min Standing, >110 mmHgn=6 Participants0-
DBP, 3 min Standing, <50 mmHgn=6 Participants0-
DBP, 3 min Standing, >110 mmHgn=6 Participants0-
Pulse, Supine, <50 beats/min (bpm)n=6 Participants0-
Pulse, Supine, >120 beats/minn=6 Participants0-
Pulse, 5 min Supine, <50 beats/minn=6 Participants16.7-
Pulse, 5 min Supine, >120 beats/minn=6 Participants0-
Pulse, 1 min Standing, <50 beats/minn=6 Participants0-
Pulse, 1 min Standing, >120 beats/minn=6 Participants0-
Pulse, 3 min Standing, <50 beats/minn=6 Participants0-
Pulse, 3 min Standing, >120 beats/minn=6 Participants0-
Temperature, <35.6 Celsius (C)n=6 Participants16.7-
Temperature, >37.7 Cn=6 Participants0-
Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHgn=6 Participants16.7-
Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHgn=6 Participants0-
Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHgn=6 Participants0-
Orthostatic Pulse, 1 min Standing-Supine >10 bpmn=6 Participants100-
Orthostatic Pulse, 3 min Standing-Supine >10 bpmn=6 Participants100-
Primary/protocol endpoint

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 8]

Time frame:Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Primary/registry result

Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose

Time frame:Day 1 up to Day 41

threshold achievement, event

Posted result

GroupValue (number), percentage of participantsReported bounds
SRD: Placebo Cohorts 1-6, 18 and 19ECG Mean Heart Rate (HR), <50 beats/minn=16 Participants37.5-
ECG Mean HR, >120 beats/minn=16 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=16 Participants0-
PR Interval, Aggregate, >=200 msecn=16 Participants18.8-
QRS Duration, Aggregate, <=80 msecn=16 Participants31.3-
QRS Duration, Aggregate, >=180 msecn=16 Participants0-
QT Interval, Aggregate, <=50 msecn=16 Participants0-
QT Interval, Aggregate, >=460 msecn=16 Participants12.5-
QTcB Interval, Aggregate, <=50 msecn=16 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=16 Participants0-
QTcF Interval, Aggregate, <=50 msecn=16 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=16 Participants0-
RR Interval, Aggregate, <=600 msecn=16 Participants0-
RR Interval, Aggregate, >=1440 msecn=16 Participants0-
SRD: Cohort 1: TAK-071 1 mgECG Mean Heart Rate (HR), <50 beats/minn=6 Participants33.3-
ECG Mean HR, >120 beats/minn=6 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=6 Participants0-
PR Interval, Aggregate, >=200 msecn=6 Participants0-
QRS Duration, Aggregate, <=80 msecn=6 Participants33.3-
QRS Duration, Aggregate, >=180 msecn=6 Participants0-
QT Interval, Aggregate, <=50 msecn=6 Participants0-
QT Interval, Aggregate, >=460 msecn=6 Participants33.3-
QTcB Interval, Aggregate, <=50 msecn=6 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants16.7-
QTcF Interval, Aggregate, <=50 msecn=6 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants16.7-
RR Interval, Aggregate, <=600 msecn=6 Participants0-
RR Interval, Aggregate, >=1440 msecn=6 Participants16.7-
SRD: Cohort 2: TAK-071 3 mgECG Mean Heart Rate (HR), <50 beats/minn=6 Participants16.7-
ECG Mean HR, >120 beats/minn=6 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=6 Participants0-
PR Interval, Aggregate, >=200 msecn=6 Participants16.7-
QRS Duration, Aggregate, <=80 msecn=6 Participants33.3-
QRS Duration, Aggregate, >=180 msecn=6 Participants0-
QT Interval, Aggregate, <=50 msecn=6 Participants0-
QT Interval, Aggregate, >=460 msecn=6 Participants16.7-
QTcB Interval, Aggregate, <=50 msecn=6 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
QTcF Interval, Aggregate, <=50 msecn=6 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
RR Interval, Aggregate, <=600 msecn=6 Participants0-
RR Interval, Aggregate, >=1440 msecn=6 Participants16.7-
SRD: Cohort 3: TAK-071 9 mgECG Mean Heart Rate (HR), <50 beats/minn=6 Participants16.7-
ECG Mean HR, >120 beats/minn=6 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=6 Participants0-
PR Interval, Aggregate, >=200 msecn=6 Participants0-
QRS Duration, Aggregate, <=80 msecn=6 Participants0-
QRS Duration, Aggregate, >=180 msecn=6 Participants0-
QT Interval, Aggregate, <=50 msecn=6 Participants0-
QT Interval, Aggregate, >=460 msecn=6 Participants0-
QTcB Interval, Aggregate, <=50 msecn=6 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
QTcF Interval, Aggregate, <=50 msecn=6 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
RR Interval, Aggregate, <=600 msecn=6 Participants0-
RR Interval, Aggregate, >=1440 msecn=6 Participants0-
SRD: Cohort 4: TAK-071 20 mgECG Mean Heart Rate (HR), <50 beats/minn=6 Participants33.3-
ECG Mean HR, >120 beats/minn=6 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=6 Participants0-
PR Interval, Aggregate, >=200 msecn=6 Participants16.7-
QRS Duration, Aggregate, <=80 msecn=6 Participants50.0-
QRS Duration, Aggregate, >=180 msecn=6 Participants0-
QT Interval, Aggregate, <=50 msecn=6 Participants0-
QT Interval, Aggregate, >=460 msecn=6 Participants0-
QTcB Interval, Aggregate, <=50 msecn=6 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
QTcF Interval, Aggregate, <=50 msecn=6 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
RR Interval, Aggregate, <=600 msecn=6 Participants0-
RR Interval, Aggregate, >=1440 msecn=6 Participants0-
SRD: Cohort 5: TAK-071 40 mgECG Mean Heart Rate (HR), <50 beats/minn=6 Participants33.3-
ECG Mean HR, >120 beats/minn=6 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=6 Participants0-
PR Interval, Aggregate, >=200 msecn=6 Participants16.7-
QRS Duration, Aggregate, <=80 msecn=6 Participants16.7-
QRS Duration, Aggregate, >=180 msecn=6 Participants0-
QT Interval, Aggregate, <=50 msecn=6 Participants0-
QT Interval, Aggregate, >=460 msecn=6 Participants0-
QTcB Interval, Aggregate, <=50 msecn=6 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
QTcF Interval, Aggregate, <=50 msecn=6 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
RR Interval, Aggregate, <=600 msecn=6 Participants0-
RR Interval, Aggregate, >=1440 msecn=6 Participants0-
SRD: Cohort 6: TAK-071 80 mgECG Mean Heart Rate (HR), <50 beats/minn=6 Participants16.7-
ECG Mean HR, >120 beats/minn=6 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=6 Participants0-
PR Interval, Aggregate, >=200 msecn=6 Participants0-
QRS Duration, Aggregate, <=80 msecn=6 Participants16.7-
QRS Duration, Aggregate, >=180 msecn=6 Participants0-
QT Interval, Aggregate, <=50 msecn=6 Participants0-
QT Interval, Aggregate, >=460 msecn=6 Participants16.7-
QTcB Interval, Aggregate, <=50 msecn=6 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
QTcF Interval, Aggregate, <=50 msecn=6 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
RR Interval, Aggregate, <=600 msecn=6 Participants0-
RR Interval, Aggregate, >=1440 msecn=6 Participants0-
MRD: Placebo Cohorts 7-9ECG Mean Heart Rate (HR), <50 beats/minn=6 Participants33.3-
ECG Mean HR, >120 beats/minn=6 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=6 Participants0-
PR Interval, Aggregate, >=200 msecn=6 Participants0-
QRS Duration, Aggregate, <=80 msecn=6 Participants33.3-
QRS Duration, Aggregate, >=180 msecn=6 Participants0-
QT Interval, Aggregate, <=50 msecn=6 Participants0-
QT Interval, Aggregate, >=460 msecn=6 Participants0-
QTcB Interval, Aggregate, <=50 msecn=6 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
QTcF Interval, Aggregate, <=50 msecn=6 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
RR Interval, Aggregate, <=600 msecn=6 Participants0-
RR Interval, Aggregate, >=1440 msecn=6 Participants0-
MRD: Cohort 7: TAK-071 3 mgECG Mean Heart Rate (HR), <50 beats/minn=6 Participants16.7-
ECG Mean HR, >120 beats/minn=6 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=6 Participants0-
PR Interval, Aggregate, >=200 msecn=6 Participants16.7-
QRS Duration, Aggregate, <=80 msecn=6 Participants16.7-
QRS Duration, Aggregate, >=180 msecn=6 Participants0-
QT Interval, Aggregate, <=50 msecn=6 Participants0-
QT Interval, Aggregate, >=460 msecn=6 Participants0-
QTcB Interval, Aggregate, <=50 msecn=6 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
QTcF Interval, Aggregate, <=50 msecn=6 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
RR Interval, Aggregate, <=600 msecn=6 Participants0-
RR Interval, Aggregate, >=1440 msecn=6 Participants0-
MRD: Cohort 8: TAK-071 9 mgECG Mean Heart Rate (HR), <50 beats/minn=6 Participants33.3-
ECG Mean HR, >120 beats/minn=6 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=6 Participants0-
PR Interval, Aggregate, >=200 msecn=6 Participants0-
QRS Duration, Aggregate, <=80 msecn=6 Participants16.7-
QRS Duration, Aggregate, >=180 msecn=6 Participants0-
QT Interval, Aggregate, <=50 msecn=6 Participants0-
QT Interval, Aggregate, >=460 msecn=6 Participants16.7-
QTcB Interval, Aggregate, <=50 msecn=6 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
QTcF Interval, Aggregate, <=50 msecn=6 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
RR Interval, Aggregate, <=600 msecn=6 Participants0-
RR Interval, Aggregate, >=1440 msecn=6 Participants16.7-
MRD: Cohort 9: TAK-071 15 mgECG Mean Heart Rate (HR), <50 beats/minn=6 Participants33.3-
ECG Mean HR, >120 beats/minn=6 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=6 Participants0-
PR Interval, Aggregate, >=200 msecn=6 Participants0-
QRS Duration, Aggregate, <=80 msecn=6 Participants16.7-
QRS Duration, Aggregate, >=180 msecn=6 Participants0-
QT Interval, Aggregate, <=50 msecn=6 Participants0-
QT Interval, Aggregate, >=460 msecn=6 Participants0-
QTcB Interval, Aggregate, <=50 msecn=6 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
QTcF Interval, Aggregate, <=50 msecn=6 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
RR Interval, Aggregate, <=600 msecn=6 Participants0-
RR Interval, Aggregate, >=1440 msecn=6 Participants0-
MRD: TAK-071 Placebo Cohorts 10-12+DonepezilECG Mean Heart Rate (HR), <50 beats/minn=6 Participants16.7-
ECG Mean HR, >120 beats/minn=6 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=6 Participants0-
PR Interval, Aggregate, >=200 msecn=6 Participants16.7-
QRS Duration, Aggregate, <=80 msecn=6 Participants50.0-
QRS Duration, Aggregate, >=180 msecn=6 Participants0-
QT Interval, Aggregate, <=50 msecn=6 Participants0-
QT Interval, Aggregate, >=460 msecn=6 Participants0-
QTcB Interval, Aggregate, <=50 msecn=6 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
QTcF Interval, Aggregate, <=50 msecn=6 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
RR Interval, Aggregate, <=600 msecn=6 Participants0-
RR Interval, Aggregate, >=1440 msecn=6 Participants0-
MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mgECG Mean Heart Rate (HR), <50 beats/minn=6 Participants33.3-
ECG Mean HR, >120 beats/minn=6 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=6 Participants0-
PR Interval, Aggregate, >=200 msecn=6 Participants16.7-
QRS Duration, Aggregate, <=80 msecn=6 Participants16.7-
QRS Duration, Aggregate, >=180 msecn=6 Participants0-
QT Interval, Aggregate, <=50 msecn=6 Participants0-
QT Interval, Aggregate, >=460 msecn=6 Participants0-
QTcB Interval, Aggregate, <=50 msecn=6 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
QTcF Interval, Aggregate, <=50 msecn=6 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
RR Interval, Aggregate, <=600 msecn=6 Participants0-
RR Interval, Aggregate, >=1440 msecn=6 Participants0-
MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mgECG Mean Heart Rate (HR), <50 beats/minn=6 Participants50.0-
ECG Mean HR, >120 beats/minn=6 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=6 Participants0-
PR Interval, Aggregate, >=200 msecn=6 Participants16.7-
QRS Duration, Aggregate, <=80 msecn=6 Participants16.7-
QRS Duration, Aggregate, >=180 msecn=6 Participants0-
QT Interval, Aggregate, <=50 msecn=6 Participants0-
QT Interval, Aggregate, >=460 msecn=6 Participants0-
QTcB Interval, Aggregate, <=50 msecn=6 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants16.7-
QTcF Interval, Aggregate, <=50 msecn=6 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
RR Interval, Aggregate, <=600 msecn=6 Participants0-
RR Interval, Aggregate, >=1440 msecn=6 Participants0-
MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mgECG Mean Heart Rate (HR), <50 beats/minn=6 Participants33.3-
ECG Mean HR, >120 beats/minn=6 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=6 Participants0-
PR Interval, Aggregate, >=200 msecn=6 Participants16.7-
QRS Duration, Aggregate, <=80 msecn=6 Participants16.7-
QRS Duration, Aggregate, >=180 msecn=6 Participants0-
QT Interval, Aggregate, <=50 msecn=6 Participants0-
QT Interval, Aggregate, >=460 msecn=6 Participants0-
QTcB Interval, Aggregate, <=50 msecn=6 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants16.7-
QTcF Interval, Aggregate, <=50 msecn=6 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
RR Interval, Aggregate, <=600 msecn=6 Participants16.7-
RR Interval, Aggregate, >=1440 msecn=6 Participants0-
MRD: Placebo Cohorts 13-15ECG Mean Heart Rate (HR), <50 beats/minn=3 Participants66.7-
ECG Mean HR, >120 beats/minn=3 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=3 Participants0-
PR Interval, Aggregate, >=200 msecn=3 Participants66.7-
QRS Duration, Aggregate, <=80 msecn=3 Participants33.3-
QRS Duration, Aggregate, >=180 msecn=3 Participants0-
QT Interval, Aggregate, <=50 msecn=3 Participants0-
QT Interval, Aggregate, >=460 msecn=3 Participants0-
QTcB Interval, Aggregate, <=50 msecn=3 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=3 Participants0-
QTcF Interval, Aggregate, <=50 msecn=3 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=3 Participants0-
RR Interval, Aggregate, <=600 msecn=3 Participants0-
RR Interval, Aggregate, >=1440 msecn=3 Participants0-
MRD: Cohort 13: TAK-071 3 mgECG Mean Heart Rate (HR), <50 beats/minn=5 Participants40.0-
ECG Mean HR, >120 beats/minn=5 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=5 Participants0-
PR Interval, Aggregate, >=200 msecn=5 Participants0-
QRS Duration, Aggregate, <=80 msecn=5 Participants40.0-
QRS Duration, Aggregate, >=180 msecn=5 Participants0-
QT Interval, Aggregate, <=50 msecn=5 Participants0-
QT Interval, Aggregate, >=460 msecn=5 Participants20.0-
QTcB Interval, Aggregate, <=50 msecn=5 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=5 Participants0-
QTcF Interval, Aggregate, <=50 msecn=5 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=5 Participants0-
RR Interval, Aggregate, <=600 msecn=5 Participants0-
RR Interval, Aggregate, >=1440 msecn=5 Participants20.0-
MRD: Cohort 14: TAK-071 9 mgECG Mean Heart Rate (HR), <50 beats/minn=5 Participants40.0-
ECG Mean HR, >120 beats/minn=5 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=5 Participants0-
PR Interval, Aggregate, >=200 msecn=5 Participants40.0-
QRS Duration, Aggregate, <=80 msecn=5 Participants20.0-
QRS Duration, Aggregate, >=180 msecn=5 Participants0-
QT Interval, Aggregate, <=50 msecn=5 Participants0-
QT Interval, Aggregate, >=460 msecn=5 Participants20.0-
QTcB Interval, Aggregate, <=50 msecn=5 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=5 Participants20.0-
QTcF Interval, Aggregate, <=50 msecn=5 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=5 Participants0-
RR Interval, Aggregate, <=600 msecn=5 Participants0-
RR Interval, Aggregate, >=1440 msecn=5 Participants20.0-
MRD: Cohort 15: TAK-071 15 mgECG Mean Heart Rate (HR), <50 beats/minn=5 Participants40.0-
ECG Mean HR, >120 beats/minn=5 Participants20.0-
PR Interval, Aggregate, <=80 millisecond (msec)n=5 Participants0-
PR Interval, Aggregate, >=200 msecn=5 Participants20.0-
QRS Duration, Aggregate, <=80 msecn=5 Participants40.0-
QRS Duration, Aggregate, >=180 msecn=5 Participants0-
QT Interval, Aggregate, <=50 msecn=5 Participants0-
QT Interval, Aggregate, >=460 msecn=5 Participants20.0-
QTcB Interval, Aggregate, <=50 msecn=5 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=5 Participants20.0-
QTcF Interval, Aggregate, <=50 msecn=5 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=5 Participants0-
RR Interval, Aggregate, <=600 msecn=5 Participants20.0-
RR Interval, Aggregate, >=1440 msecn=5 Participants0-
Bioavailability (BA)/Food Effect: Cohort 17 Regimen AECG Mean Heart Rate (HR), <50 beats/minn=12 Participants58.3-
ECG Mean HR, >120 beats/minn=12 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=12 Participants0-
PR Interval, Aggregate, >=200 msecn=12 Participants33.3-
QRS Duration, Aggregate, <=80 msecn=12 Participants8.3-
QRS Duration, Aggregate, >=180 msecn=12 Participants0-
QT Interval, Aggregate, <=50 msecn=12 Participants0-
QT Interval, Aggregate, >=460 msecn=12 Participants16.7-
QTcB Interval, Aggregate, <=50 msecn=12 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=12 Participants8.3-
QTcF Interval, Aggregate, <=50 msecn=12 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=12 Participants0-
RR Interval, Aggregate, <=600 msecn=12 Participants0-
RR Interval, Aggregate, >=1440 msecn=12 Participants0-
BA/Food Effect: Cohort 17 Regimen BECG Mean Heart Rate (HR), <50 beats/minn=12 Participants41.7-
ECG Mean HR, >120 beats/minn=12 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=12 Participants0-
PR Interval, Aggregate, >=200 msecn=12 Participants25.0-
QRS Duration, Aggregate, <=80 msecn=12 Participants16.7-
QRS Duration, Aggregate, >=180 msecn=12 Participants0-
QT Interval, Aggregate, <=50 msecn=12 Participants0-
QT Interval, Aggregate, >=460 msecn=12 Participants16.7-
QTcB Interval, Aggregate, <=50 msecn=12 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=12 Participants0-
QTcF Interval, Aggregate, <=50 msecn=12 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=12 Participants0-
RR Interval, Aggregate, <=600 msecn=12 Participants0-
RR Interval, Aggregate, >=1440 msecn=12 Participants0-
BA/Food Effect: Cohort 17 Regimen CECG Mean Heart Rate (HR), <50 beats/minn=12 Participants33.3-
ECG Mean HR, >120 beats/minn=12 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=12 Participants0-
PR Interval, Aggregate, >=200 msecn=12 Participants25.0-
QRS Duration, Aggregate, <=80 msecn=12 Participants16.7-
QRS Duration, Aggregate, >=180 msecn=12 Participants0-
QT Interval, Aggregate, <=50 msecn=12 Participants0-
QT Interval, Aggregate, >=460 msecn=12 Participants8.3-
QTcB Interval, Aggregate, <=50 msecn=12 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=12 Participants0-
QTcF Interval, Aggregate, <=50 msecn=12 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=12 Participants0-
RR Interval, Aggregate, <=600 msecn=12 Participants0-
RR Interval, Aggregate, >=1440 msecn=12 Participants0-
SRD: Cohort 18: TAK-071 120 mgECG Mean Heart Rate (HR), <50 beats/minn=6 Participants66.7-
ECG Mean HR, >120 beats/minn=6 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=6 Participants0-
PR Interval, Aggregate, >=200 msecn=6 Participants0-
QRS Duration, Aggregate, <=80 msecn=6 Participants16.7-
QRS Duration, Aggregate, >=180 msecn=6 Participants0-
QT Interval, Aggregate, <=50 msecn=6 Participants0-
QT Interval, Aggregate, >=460 msecn=6 Participants16.7-
QTcB Interval, Aggregate, <=50 msecn=6 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
QTcF Interval, Aggregate, <=50 msecn=6 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
RR Interval, Aggregate, <=600 msecn=6 Participants0-
RR Interval, Aggregate, >=1440 msecn=6 Participants16.7-
SRD: Cohort 19: TAK-071 160 mgECG Mean Heart Rate (HR), <50 beats/minn=6 Participants0-
ECG Mean HR, >120 beats/minn=6 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=6 Participants0-
PR Interval, Aggregate, >=200 msecn=6 Participants0-
QRS Duration, Aggregate, <=80 msecn=6 Participants50.0-
QRS Duration, Aggregate, >=180 msecn=6 Participants0-
QT Interval, Aggregate, <=50 msecn=6 Participants0-
QT Interval, Aggregate, >=460 msecn=6 Participants0-
QTcB Interval, Aggregate, <=50 msecn=6 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
QTcF Interval, Aggregate, <=50 msecn=6 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
RR Interval, Aggregate, <=600 msecn=6 Participants0-
RR Interval, Aggregate, >=1440 msecn=6 Participants0-
SRD: TAK-071 Placebo+Donepezil PlaceboECG Mean Heart Rate (HR), <50 beats/minn=9 Participants44.4-
ECG Mean HR, >120 beats/minn=9 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=9 Participants0-
PR Interval, Aggregate, >=200 msecn=9 Participants11.1-
QRS Duration, Aggregate, <=80 msecn=9 Participants11.1-
QRS Duration, Aggregate, >=180 msecn=9 Participants0-
QT Interval, Aggregate, <=50 msecn=9 Participants0-
QT Interval, Aggregate, >=460 msecn=9 Participants11.1-
QTcB Interval, Aggregate, <=50 msecn=9 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=9 Participants0-
QTcF Interval, Aggregate, <=50 msecn=9 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=9 Participants0-
RR Interval, Aggregate, <=600 msecn=9 Participants0-
RR Interval, Aggregate, >=1440 msecn=9 Participants11.1-
SRD: TAK-071 Placebo+DonepezilECG Mean Heart Rate (HR), <50 beats/minn=9 Participants22.2-
ECG Mean HR, >120 beats/minn=9 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=9 Participants0-
PR Interval, Aggregate, >=200 msecn=9 Participants11.1-
QRS Duration, Aggregate, <=80 msecn=9 Participants11.1-
QRS Duration, Aggregate, >=180 msecn=9 Participants0-
QT Interval, Aggregate, <=50 msecn=9 Participants0-
QT Interval, Aggregate, >=460 msecn=9 Participants11.1-
QTcB Interval, Aggregate, <=50 msecn=9 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=9 Participants0-
QTcF Interval, Aggregate, <=50 msecn=9 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=9 Participants0-
RR Interval, Aggregate, <=600 msecn=9 Participants0-
RR Interval, Aggregate, >=1440 msecn=9 Participants11.1-
SRD: Cohort 20: TAK-071 40 mg+DonepezilECG Mean Heart Rate (HR), <50 beats/minn=5 Participants60.0-
ECG Mean HR, >120 beats/minn=5 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=5 Participants0-
PR Interval, Aggregate, >=200 msecn=5 Participants20.0-
QRS Duration, Aggregate, <=80 msecn=5 Participants20.0-
QRS Duration, Aggregate, >=180 msecn=5 Participants0-
QT Interval, Aggregate, <=50 msecn=5 Participants0-
QT Interval, Aggregate, >=460 msecn=5 Participants40.0-
QTcB Interval, Aggregate, <=50 msecn=5 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=5 Participants20.0-
QTcF Interval, Aggregate, <=50 msecn=5 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=5 Participants0-
RR Interval, Aggregate, <=600 msecn=5 Participants0-
RR Interval, Aggregate, >=1440 msecn=5 Participants0-
SRD: Cohort 21: TAK-071 60 mg+DonepezilECG Mean Heart Rate (HR), <50 beats/minn=6 Participants33.3-
ECG Mean HR, >120 beats/minn=6 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=6 Participants0-
PR Interval, Aggregate, >=200 msecn=6 Participants0-
QRS Duration, Aggregate, <=80 msecn=6 Participants0-
QRS Duration, Aggregate, >=180 msecn=6 Participants0-
QT Interval, Aggregate, <=50 msecn=6 Participants0-
QT Interval, Aggregate, >=460 msecn=6 Participants0-
QTcB Interval, Aggregate, <=50 msecn=6 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
QTcF Interval, Aggregate, <=50 msecn=6 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
RR Interval, Aggregate, <=600 msecn=6 Participants0-
RR Interval, Aggregate, >=1440 msecn=6 Participants0-
SRD: Cohort 22: TAK-071 80 mg+DonepezilECG Mean Heart Rate (HR), <50 beats/minn=6 Participants50.0-
ECG Mean HR, >120 beats/minn=6 Participants0-
PR Interval, Aggregate, <=80 millisecond (msec)n=6 Participants0-
PR Interval, Aggregate, >=200 msecn=6 Participants16.7-
QRS Duration, Aggregate, <=80 msecn=6 Participants16.7-
QRS Duration, Aggregate, >=180 msecn=6 Participants0-
QT Interval, Aggregate, <=50 msecn=6 Participants0-
QT Interval, Aggregate, >=460 msecn=6 Participants0-
QTcB Interval, Aggregate, <=50 msecn=6 Participants0-
QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
QTcF Interval, Aggregate, <=50 msecn=6 Participants0-
QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msecn=6 Participants0-
RR Interval, Aggregate, <=600 msecn=6 Participants0-
RR Interval, Aggregate, >=1440 msecn=6 Participants0-
Primary/protocol endpoint

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 28]

Time frame:Pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Primary/registry result

Tmax: Time of First Occurrence of Cmax for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

concentration, descriptive

Posted result

GroupValue (median), hoursReported bounds
SRD: Cohort 1: TAK-071 1 mgn=6 Participants1.750-1.48 - 4.00
SRD: Cohort 2: TAK-071 3 mgn=6 Participants4.017-3.00 - 23.95
SRD: Cohort 3: TAK-071 9 mgn=6 Participants10.975-3.00 - 24.00
SRD: Cohort 4: TAK-071 20 mgn=6 Participants8.000-4.02 - 24.02
SRD: Cohort 5: TAK-071 40 mgn=6 Participants9.933-3.00 - 48.00
SRD: Cohort 6: TAK-071 80 mgn=6 Participants24.033-12.02 - 48.07
SRD: Cohort 18: TAK-071 120 mgn=6 Participants22.050-8.00 - 39.95
SRD: Cohort 19: TAK-071 160 mgn=6 Participants24.058-24.00 - 32.00
Primary/protocol endpoint

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 1]

Time frame:Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Primary/registry result

Tmax: Time of First Occurrence of Cmax for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1]

Time frame:Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Posted result

GroupValue (median), hoursReported bounds
MRD: Cohort 7: TAK-071 3 mgn=6 Participants2.500-2.00 - 10.00
MRD: Cohort 8: TAK-071 9 mgn=6 Participants7.000-3.00 - 12.00
Primary/protocol endpoint

AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-071 Relative Bioavailability and Food Effect

Time frame:Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose

concentration, descriptive

Primary/registry result

Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 21]

Time frame:Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Posted result

GroupValue (median), hoursReported bounds
MRD: Cohort 7: TAK-071 3 mgn=6 Participants2.500-2.00 - 6.00
MRD: Cohort 8: TAK-071 9 mgn=6 Participants4.000-2.00 - 12.05
Primary/protocol endpoint

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil

Time frame:Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

concentration, descriptive

Primary/registry result

Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 1]

Time frame:Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), hoursReported bounds
MRD: Cohort 9: TAK-071 15 mgn=6 Participants24.058-3.05 - 24.38
Primary/protocol endpoint

AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points [up to 168 hours] post-dose

concentration, descriptive

Primary/registry result

Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 8]

Time frame:Pre-dose on Day 8 and multiple time points (up to 24 hour) post-dose

concentration, descriptive

Posted result

GroupValue (median), hoursReported bounds
MRD: Cohort 9: TAK-071 15 mgn=6 Participants11.017-2.00 - 23.87
Primary/protocol endpoint

AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants TAK-071 + Donepezil

Time frame:Pre-dose on Day 1 and at multiple time points [up to 168 hours] post-dose

concentration, descriptive

Primary/registry result

Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 28]

Time frame:Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), hoursReported bounds
MRD: Cohort 9: TAK-071 15 mgn=6 Participants3.000-1.00 - 12.00
Primary/registry result

Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 1]

Time frame:Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose

concentration, descriptive

Posted result

GroupValue (median), hoursReported bounds
MRD: Cohort 13: TAK-071 3 mgn=5 Participants4.000-4.00 - 8.00
MRD: Cohort 14: TAK-071 9 mgn=5 Participants6.000-2.00 - 12.00
MRD: Cohort 15: TAK-071 15 mgn=5 Participants12.000-6.00 - 14.00
Primary/registry result

Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 8]

Time frame:Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Posted result

GroupValue (median), hoursReported bounds
MRD: Cohort 13: TAK-071 3 mgn=5 Participants4.000-3.00 - 6.00
MRD: Cohort 14: TAK-071 9 mgn=5 Participants6.000-6.00 - 23.75
MRD: Cohort 15: TAK-071 15 mgn=5 Participants8.000-3.00 - 23.90
Primary/registry result

Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 28]

Time frame:Pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Posted result

GroupValue (median), hoursReported bounds
MRD: Cohort 13: TAK-071 3 mgn=5 Participants4.000-3.00 - 4.00
MRD: Cohort 14: TAK-071 9 mgn=5 Participants3.000-1.50 - 6.05
MRD: Cohort 15: TAK-071 15 mgn=5 Participants3.000-1.50 - 6.00
Primary/registry result

Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 1]

Time frame:Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Posted result

GroupValue (median), hoursReported bounds
MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mgn=6 Participants3.508-2.00 - 8.00
MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mgn=6 Participants4.992-3.00 - 10.00
MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mgn=6 Participants7.000-3.00 - 14.00
Primary/registry result

Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 21]

Time frame:Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Posted result

GroupValue (median), hoursReported bounds
MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mgn=6 Participants3.500-2.00 - 6.00
MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mgn=6 Participants3.008-2.00 - 4.00
MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mgn=6 Participants3.500-1.50 - 6.00
Primary/registry result

Tmax: Time of First Occurrence of Cmax for TAK-071 Relative Bioavailability and Food Effect

Time frame:Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose

concentration, descriptive

Posted result

GroupValue (median), hoursReported bounds
Bioavailability (BA)/Food Effect: Cohort 17 Regimen An=12 Participants4.983-3.00 - 32.00
BA/Food Effect: Cohort 17 Regimen Bn=12 Participants2.000-1.00 - 8.00
BA/Food Effect: Cohort 17 Regimen Cn=12 Participants6.000-1.00 - 24.00
Primary/registry result

Tmax: Time of First Occurrence of Cmax for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil

Time frame:Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

concentration, descriptive

Posted result

GroupValue (median), hoursReported bounds
SRD: Cohort 20: TAK-071 40 mg+Donepeziln=3 Participants26.000-12.05 - 30.17
SRD: Cohort 21: TAK-071 60 mg+Donepeziln=6 Participants26.000-4.02 - 27.00
SRD: Cohort 22: TAK-071 80 mg+Donepeziln=5 Participants30.000-28.00 - 32.00
Primary/registry result

Cmax: Maximum Observed Plasma Concentration for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), ng/mLStandard deviation
SRD: Cohort 1: TAK-071 1 mgn=6 Participants25.655.8589
SRD: Cohort 2: TAK-071 3 mgn=6 Participants65.825.4268
SRD: Cohort 3: TAK-071 9 mgn=6 Participants162.236.548
SRD: Cohort 4: TAK-071 20 mgn=6 Participants328.072.200
SRD: Cohort 5: TAK-071 40 mgn=6 Participants485.7240.47
SRD: Cohort 6: TAK-071 80 mgn=6 Participants901.7210.05
SRD: Cohort 18: TAK-071 120 mgn=6 Participants1292315.30
SRD: Cohort 19: TAK-071 160 mgn=6 Participants1387312.13
Primary/registry result

Cmax: Maximum Observed Plasma Concentration for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1]

Time frame:Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), ng/mLStandard deviation
MRD: Cohort 7: TAK-071 3 mgn=6 Participants74.3318.186
MRD: Cohort 8: TAK-071 9 mgn=6 Participants196.254.668
Primary/registry result

Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 21]

Time frame:Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), ng/mLStandard deviation
MRD: Cohort 7: TAK-071 3 mgn=6 Participants244.566.163
MRD: Cohort 8: TAK-071 9 mgn=6 Participants646.595.032
Primary/registry result

Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 1]

Time frame:Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), ng/mLStandard deviation
MRD: Cohort 9: TAK-071 15 mgn=6 Participants264.870.516
Primary/registry result

Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 8]

Time frame:Pre-dose on Day 8 and multiple time points (up to 24 hour) post-dose

concentration, descriptive

Posted result

GroupValue (mean), ng/mLStandard deviation
MRD: Cohort 9: TAK-071 15 mgn=6 Participants294.257.007
Primary/registry result

Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 28]

Time frame:Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), ng/mLStandard deviation
MRD: Cohort 9: TAK-071 15 mgn=5 Participants936.4173.98
Primary/registry result

Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 1]

Time frame:Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), ng/mLStandard deviation
MRD: Cohort 13: TAK-071 3 mgn=5 Participants78.9810.736
MRD: Cohort 14: TAK-071 9 mgn=5 Participants208.447.773
MRD: Cohort 15: TAK-071 15 mgn=5 Participants278.063.828
Primary/registry result

Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 8]

Time frame:Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), ng/mLStandard deviation
MRD: Cohort 13: TAK-071 3 mgn=5 Participants81.1617.379
MRD: Cohort 14: TAK-071 9 mgn=5 Participants235.437.740
MRD: Cohort 15: TAK-071 15 mgn=5 Participants329.699.889
Primary/registry result

Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 28]

Time frame:Pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), ng/mLStandard deviation
MRD: Cohort 13: TAK-071 3 mgn=5 Participants235.649.242
MRD: Cohort 14: TAK-071 9 mgn=5 Participants680.2181.99
MRD: Cohort 15: TAK-071 15 mgn=5 Participants895.2420.14
Primary/registry result

Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 1]

Time frame:Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), ng/mLStandard deviation
MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mgn=6 Participants79.1212.954
MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mgn=6 Participants194.217.325
MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mgn=6 Participants303.732.371
Primary/registry result

Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 21]

Time frame:Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), ng/mLStandard deviation
MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mgn=6 Participants232.869.277
MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mgn=6 Participants678.067.620
MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mgn=6 Participants970.7228.98
Primary/registry result

Cmax: Maximum Observed Plasma Concentration for TAK-071 Relative Bioavailability and Food Effect

Time frame:Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), ng/mLStandard deviation
Bioavailability (BA)/Food Effect: Cohort 17 Regimen An=12 Participants219.746.986
BA/Food Effect: Cohort 17 Regimen Bn=12 Participants251.041.946
BA/Food Effect: Cohort 17 Regimen Cn=12 Participants242.541.513
Primary/registry result

Cmax: Maximum Observed Plasma Concentration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil

Time frame:Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), ng/mLStandard deviation
SRD: Cohort 20: TAK-071 40 mg+Donepeziln=3 Participants111085.440
SRD: Cohort 21: TAK-071 60 mg+Donepeziln=6 Participants725.8186.03
SRD: Cohort 22: TAK-071 80 mg+Donepeziln=5 Participants532.228.508
Primary/registry result

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), h*ng/mLStandard deviation
SRD: Cohort 1: TAK-071 1 mgn=6 Participants459.3111.88
SRD: Cohort 2: TAK-071 3 mgn=6 Participants119792.810
SRD: Cohort 3: TAK-071 9 mgn=6 Participants3257634.89
SRD: Cohort 4: TAK-071 20 mgn=6 Participants63831162.4
SRD: Cohort 5: TAK-071 40 mgn=6 Participants89054529.9
SRD: Cohort 6: TAK-071 80 mgn=6 Participants163003468.9
SRD: Cohort 18: TAK-071 120 mgn=6 Participants223507203.2
SRD: Cohort 19: TAK-071 160 mgn=6 Participants256608297.7
Primary/registry result

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1]

Time frame:Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), h*ng/mLStandard deviation
MRD: Cohort 7: TAK-071 3 mgn=6 Participants1347302.98
MRD: Cohort 8: TAK-071 9 mgn=6 Participants3550765.01
Primary/registry result

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 21]

Time frame:Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), h*ng/mLStandard deviation
MRD: Cohort 7: TAK-071 3 mgn=6 Participants47831258.0
MRD: Cohort 8: TAK-071 9 mgn=6 Participants125202132.7
Primary/registry result

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 1]

Time frame:Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), h*ng/mLStandard deviation
MRD: Cohort 9: TAK-071 15 mgn=6 Participants53321688.9
Primary/registry result

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 8]

Time frame:Pre-dose on Day 8 and multiple time points (up to 24 hour) post-dose

concentration, descriptive

Posted result

GroupValue (mean), h*ng/mLStandard deviation
MRD: Cohort 9: TAK-071 15 mgn=6 Participants5831998.50
Primary/registry result

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 28]

Time frame:Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), h*ng/mLStandard deviation
MRD: Cohort 9: TAK-071 15 mgn=5 Participants199204563.7
Primary/registry result

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 1]

Time frame:Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), h*ng/mLStandard deviation
MRD: Cohort 13: TAK-071 3 mgn=5 Participants1485271.95
MRD: Cohort 14: TAK-071 9 mgn=5 Participants4201822.67
MRD: Cohort 15: TAK-071 15 mgn=5 Participants55811141.6
Primary/registry result

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 8]

Time frame:Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), h*ng/mLStandard deviation
MRD: Cohort 13: TAK-071 3 mgn=5 Participants1529344.00
MRD: Cohort 14: TAK-071 9 mgn=5 Participants4634787.02
MRD: Cohort 15: TAK-071 15 mgn=5 Participants61101217.2
Primary/registry result

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 28]

Time frame:Pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), h*ng/mLStandard deviation
MRD: Cohort 13: TAK-071 3 mgn=5 Participants44391135.6
MRD: Cohort 14: TAK-071 9 mgn=5 Participants134503024.3
MRD: Cohort 15: TAK-071 15 mgn=5 Participants171208088.8
Primary/registry result

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 1]

Time frame:Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), h*ng/mLStandard deviation
MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mgn=6 Participants1442251.62
MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mgn=6 Participants3636286.83
MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mgn=6 Participants5832921.06
Primary/registry result

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 21]

Time frame:Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), h*ng/mLStandard deviation
MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mgn=6 Participants44671461.6
MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mgn=6 Participants135701647.0
MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mgn=6 Participants192104669.4
Primary/registry result

AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-071 Relative Bioavailability and Food Effect

Time frame:Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), h*ng/mLStandard deviation
Bioavailability (BA)/Food Effect: Cohort 17 Regimen An=12 Participants160104812.0
BA/Food Effect: Cohort 17 Regimen Bn=12 Participants151904576.6
BA/Food Effect: Cohort 17 Regimen Cn=12 Participants166105003.1
Primary/registry result

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil

Time frame:Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), h*ng/mLStandard deviation
SRD: Cohort 20: TAK-071 40 mg+Donepeziln=3 Participants183702361.9
SRD: Cohort 21: TAK-071 60 mg+Donepeziln=6 Participants128102177.9
SRD: Cohort 22: TAK-071 80 mg+Donepeziln=5 Participants94401353.7
Primary/registry result

AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points [up to 168 hours] post-dose

concentration, descriptive

Posted result

GroupValue (mean), h*ng/mLStandard deviation
SRD: Cohort 1: TAK-071 1 mgn=6 Participants1651644.79
SRD: Cohort 2: TAK-071 3 mgn=6 Participants50703802.0
SRD: Cohort 3: TAK-071 9 mgn=6 Participants156405944.7
SRD: Cohort 4: TAK-071 20 mgn=6 Participants309805932.8
SRD: Cohort 5: TAK-071 40 mgn=6 Participants4955033766
SRD: Cohort 6: TAK-071 80 mgn=6 Participants10600019610
SRD: Cohort 18: TAK-071 120 mgn=6 Participants13270046773
SRD: Cohort 19: TAK-071 160 mgn=6 Participants16210069191
Primary/registry result

AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants TAK-071 + Donepezil

Time frame:Pre-dose on Day 1 and at multiple time points [up to 168 hours] post-dose

concentration, descriptive

Posted result

GroupValue (mean), h*ng/mLStandard deviation
SRD: Cohort 20: TAK-071 40 mg+Donepeziln=3 Participants9764022123
SRD: Cohort 21: TAK-071 60 mg+Donepeziln=6 Participants4875012598
SRD: Cohort 22: TAK-071 80 mg+Donepeziln=5 Participants463706094.8
Secondary/protocol endpoint

Terminal Disposition Phase Half-life (t1/2z) for TAK-071 SRD Non-Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

concentration, descriptive

Secondary/protocol endpoint

Terminal Disposition Phase Half-life (t1/2z) for TAK-071 Relative Bioavailability and Food Effect

Time frame:Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose

concentration, descriptive

Secondary/protocol endpoint

Terminal Disposition Phase Half-life (t1/2z) for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil

Time frame:Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose

concentration, descriptive

Secondary/protocol endpoint

Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Non-Japanese Participants

Time frame:Pre-dose on Day 21 and at multiple time points (up to 24 hours) post-dose for Cohorts 7 and 8 and Pre-dose on Day 28 and at multiple time points (up to 36 hours) post-dose for Cohort 9

concentration, descriptive

Secondary/protocol endpoint

Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Japanese Participants

Time frame:Pre-dose on Day 28 and at multiple time points [up to 24 hours] post-dose

concentration, descriptive

Secondary/protocol endpoint

Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Non-Japanese Participants

Time frame:Pre-dose on Day 21 and at multiple time points [up to 24 hours] post-dose

concentration, descriptive

Secondary/protocol endpoint

Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Non-Japanese Participants

Time frame:Pre-dose on Day 21 and at multiple time points [up to 24 hours] post-dose for Cohorts 7 and 8 and Pre-dose on Day 28 and at multiple time points (up to 36 hours) post-dose for Cohort 9

concentration, descriptive

Secondary/protocol endpoint

Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Japanese Participants

Time frame:Pre-dose on Day 28 and at multiple time points [up to 24 hours] post-dose

concentration, descriptive

Secondary/protocol endpoint

Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Non-Japanese Participants

Time frame:Pre-dose on Day 21 and at multiple time points [up to 24 hours] post-dose

concentration, descriptive

Secondary/protocol endpoint

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Donepezil MRD Non-Japanese Participants

Time frame:Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose

time to event, event

Secondary/protocol endpoint

Cmax: Maximum Observed Plasma Concentration for Donepezil MRD Non-Japanese Participants

Time frame:Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Secondary/protocol endpoint

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Donepezil

Time frame:Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Secondary/protocol endpoint

Ratio of Geometric Mean of Cmax for Donepezil After 21 Daily Doses of TAK-071

Time frame:Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Secondary/protocol endpoint

Ratio of Geometric Mean of AUC(0-24) for Donepezil After 21 Daily Doses of TAK-071

Time frame:Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Secondary/registry result

Terminal Disposition Phase Half-life (t1/2z) for TAK-071 SRD Non-Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

concentration, descriptive

Posted result

GroupValue (median), hoursReported bounds
SRD: Cohort 1: TAK-071 1 mgn=6 Participants50.894-30.41 - 57.35
SRD: Cohort 2: TAK-071 3 mgn=6 Participants35.567-23.34 - 132.30
SRD: Cohort 3: TAK-071 9 mgn=6 Participants54.998-24.53 - 106.28
SRD: Cohort 4: TAK-071 20 mgn=6 Participants57.504-41.58 - 84.66
SRD: Cohort 5: TAK-071 40 mgn=6 Participants53.219-22.51 - 99.01
SRD: Cohort 6: TAK-071 80 mgn=6 Participants55.246-32.94 - 68.05
SRD: Cohort 18: TAK-071 120 mgn=6 Participants51.933-32.02 - 84.96
SRD: Cohort 19: TAK-071 160 mgn=6 Participants58.165-32.58 - 87.60
Secondary/registry result

Terminal Disposition Phase Half-life (t1/2z) for TAK-071 Relative Bioavailability and Food Effect

Time frame:Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose

concentration, descriptive

Posted result

GroupValue (median), hoursReported bounds
Bioavailability (BA)/Food Effect: Cohort 17 Regimen An=12 Participants48.804-23.44 - 92.82
BA/Food Effect: Cohort 17 Regimen Bn=12 Participants50.590-23.31 - 94.14
BA/Food Effect: Cohort 17 Regimen Cn=12 Participants49.796-23.35 - 100.82
Secondary/registry result

Terminal Disposition Phase Half-life (t1/2z) for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil

Time frame:Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose

concentration, descriptive

Posted result

GroupValue (median), hoursReported bounds
SRD: Cohort 20: TAK-071 40 mg+Donepeziln=3 Participants42.923-40.47 - 67.70
SRD: Cohort 21: TAK-071 60 mg+Donepeziln=6 Participants33.505-21.92 - 56.08
SRD: Cohort 22: TAK-071 80 mg+Donepeziln=5 Participants50.077-37.37 - 63.32
Secondary/registry result

Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Non-Japanese Participants

Time frame:Pre-dose on Day 21 and at multiple time points (up to 24 hours) post-dose for Cohorts 7 and 8 and Pre-dose on Day 28 and at multiple time points (up to 36 hours) post-dose for Cohort 9

concentration, descriptive

Posted result

GroupValue (mean), RatioStandard deviation
MRD: Cohort 7: TAK-071 3 mgn=6 Participants3.5680.71765
MRD: Cohort 8: TAK-071 9 mgn=6 Participants3.7131.1916
MRD: Cohort 9: TAK-071 15 mgn=5 Participants3.7781.2626
Secondary/registry result

Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Japanese Participants

Time frame:Pre-dose on Day 28 and at multiple time points [up to 24 hours] post-dose

concentration, descriptive

Posted result

GroupValue (mean), RatioStandard deviation
MRD: Cohort 13: TAK-071 3 mgn=5 Participants2.9730.38747
MRD: Cohort 14: TAK-071 9 mgn=5 Participants3.2410.56613
MRD: Cohort 15: TAK-071 15 mgn=5 Participants3.0961.4212
Secondary/registry result

Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Non-Japanese Participants

Time frame:Pre-dose on Day 21 and at multiple time points [up to 24 hours] post-dose

concentration, descriptive

Posted result

GroupValue (mean), RatioStandard deviation
MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mgn=6 Participants3.0990.75130
MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mgn=6 Participants3.7490.55862
MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mgn=6 Participants3.3500.92710
Secondary/registry result

Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Non-Japanese Participants

Time frame:Pre-dose on Day 21 and at multiple time points [up to 24 hours] post-dose for Cohorts 7 and 8 and Pre-dose on Day 28 and at multiple time points (up to 36 hours) post-dose for Cohort 9

concentration, descriptive

Posted result

GroupValue (mean), RatioStandard deviation
MRD: Cohort 7: TAK-071 3 mgn=6 Participants3.2970.59164
MRD: Cohort 8: TAK-071 9 mgn=6 Participants3.5781.2955
MRD: Cohort 9: TAK-071 15 mgn=5 Participants3.5410.86317
Secondary/registry result

Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Japanese Participants

Time frame:Pre-dose on Day 28 and at multiple time points [up to 24 hours] post-dose

concentration, descriptive

Posted result

GroupValue (mean), RatioStandard deviation
MRD: Cohort 13: TAK-071 3 mgn=5 Participants2.9600.26180
MRD: Cohort 14: TAK-071 9 mgn=5 Participants3.3270.74832
MRD: Cohort 15: TAK-071 15 mgn=5 Participants3.2851.5406
Secondary/registry result

Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Non-Japanese Participants

Time frame:Pre-dose on Day 21 and at multiple time points [up to 24 hours] post-dose

concentration, descriptive

Posted result

GroupValue (mean), RatioStandard deviation
MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mgn=6 Participants2.9290.55096
MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mgn=6 Participants3.5270.57233
MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mgn=6 Participants3.2570.95527
Secondary/registry result

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Donepezil MRD Non-Japanese Participants

Time frame:Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose

time to event, event

Posted result

GroupValue (median), hoursReported bounds
MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mgDay -1n=6 Participants3.000-1.00 - 3.00
Day 21n=6 Participants2.508-1.00 - 10.03
MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mgDay -1n=6 Participants3.000-2.00 - 4.00
Day 21n=6 Participants3.500-2.00 - 8.00
MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mgDay -1n=6 Participants3.008-2.00 - 6.00
Day 21n=6 Participants2.500-1.00 - 3.00
Secondary/registry result

Cmax: Maximum Observed Plasma Concentration for Donepezil MRD Non-Japanese Participants

Time frame:Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), ng/mLStandard error
MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mgDay -1n=6 Participants23.073.6855
Day 21n=6 Participants26.582.3659
MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mgDay -1n=6 Participants30.655.9433
Day 21n=6 Participants29.956.4071
MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mgDay -1n=6 Participants22.634.2697
Day 21n=6 Participants25.975.6163
Secondary/registry result

AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Donepezil

Time frame:Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), h*ng/mLStandard deviation
MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mgDay -1n=6 Participants410.179.220
Day 21n=6 Participants472.562.377
MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mgDay -1n=6 Participants543.8113.62
Day 21n=6 Participants567.2135.33
MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mgDay -1n=6 Participants399.596.519
Day 21n=6 Participants430.5111.93
Secondary/registry result

Ratio of Geometric Mean of Cmax for Donepezil After 21 Daily Doses of TAK-071

Time frame:Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Posted result

GroupValue (number), RatioReported bounds
MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mgn=8 Participants1.160-1.072 - 1.256
MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mgn=8 Participants0.969-0.914 - 1.028
MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mgn=8 Participants1.121-1.027 - 1.224
Secondary/registry result

Ratio of Geometric Mean of AUC(0-24) for Donepezil After 21 Daily Doses of TAK-071

Time frame:Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Posted result

GroupValue (number), RatioReported bounds
MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mgn=8 Participants1.155-1.059 - 1.260
MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mgn=8 Participants1.055-0.989 - 1.126
MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mgn=8 Participants1.106-1.014 - 1.207

Other (unclassified)

44 endpoints
Primary/protocol endpoint/low confidence

Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose

Time frame:Day 1 up to Day 41

threshold achievement, improvement

Primary/registry result/low confidence

Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose

Time frame:Day 1 up to Day 41

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participantsReported bounds
SRD: Placebo Cohorts 1-6, 18 and 19Bilirubin (>2.0 mg/dL, >34.2 umol/L)n=16 Participants0-
Creatine Kinase (>5*ULN)n=16 Participants6.3-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=16 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=16 Participants0-
Aspartate Aminotransferase (>3*ULN)n=16 Participants0-
SRD: Cohort 1: TAK-071 1 mgBilirubin (>2.0 mg/dL, >34.2 umol/L)n=6 Participants0-
Creatine Kinase (>5*ULN)n=6 Participants0-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=6 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=6 Participants0-
Aspartate Aminotransferase (>3*ULN)n=6 Participants0-
SRD: Cohort 2: TAK-071 3 mgBilirubin (>2.0 mg/dL, >34.2 umol/L)n=6 Participants0-
Creatine Kinase (>5*ULN)n=6 Participants0-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=6 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=6 Participants0-
Aspartate Aminotransferase (>3*ULN)n=6 Participants0-
SRD: Cohort 3: TAK-071 9 mgBilirubin (>2.0 mg/dL, >34.2 umol/L)n=6 Participants16.7-
Creatine Kinase (>5*ULN)n=6 Participants16.7-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=6 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=6 Participants0-
Aspartate Aminotransferase (>3*ULN)n=6 Participants0-
SRD: Cohort 4: TAK-071 20 mgBilirubin (>2.0 mg/dL, >34.2 umol/L)n=6 Participants0-
Creatine Kinase (>5*ULN)n=6 Participants0-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=6 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=6 Participants0-
Aspartate Aminotransferase (>3*ULN)n=6 Participants0-
SRD: Cohort 5: TAK-071 40 mgBilirubin (>2.0 mg/dL, >34.2 umol/L)n=6 Participants0-
Creatine Kinase (>5*ULN)n=6 Participants0-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=6 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=6 Participants0-
Aspartate Aminotransferase (>3*ULN)n=6 Participants0-
SRD: Cohort 6: TAK-071 80 mgBilirubin (>2.0 mg/dL, >34.2 umol/L)n=6 Participants0-
Creatine Kinase (>5*ULN)n=6 Participants0-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=6 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=6 Participants0-
Aspartate Aminotransferase (>3*ULN)n=6 Participants0-
MRD: Placebo Cohorts 7-9Bilirubin (>2.0 mg/dL, >34.2 umol/L)n=6 Participants0-
Creatine Kinase (>5*ULN)n=6 Participants0-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=6 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=6 Participants0-
Aspartate Aminotransferase (>3*ULN)n=6 Participants0-
MRD: Cohort 7: TAK-071 3 mgBilirubin (>2.0 mg/dL, >34.2 umol/L)n=6 Participants0-
Creatine Kinase (>5*ULN)n=6 Participants0-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=6 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=6 Participants0-
Aspartate Aminotransferase (>3*ULN)n=6 Participants0-
MRD: Cohort 8: TAK-071 9 mgBilirubin (>2.0 mg/dL, >34.2 umol/L)n=6 Participants0-
Creatine Kinase (>5*ULN)n=6 Participants0-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=6 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=6 Participants0-
Aspartate Aminotransferase (>3*ULN)n=6 Participants0-
MRD: Cohort 9: TAK-071 15 mgBilirubin (>2.0 mg/dL, >34.2 umol/L)n=6 Participants0-
Creatine Kinase (>5*ULN)n=6 Participants0-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=6 Participants16.7-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=6 Participants0-
Aspartate Aminotransferase (>3*ULN)n=6 Participants0-
MRD: TAK-071 Placebo Cohorts 10-12+DonepezilBilirubin (>2.0 mg/dL, >34.2 umol/L)n=6 Participants0-
Creatine Kinase (>5*ULN)n=6 Participants0-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=6 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=6 Participants0-
Aspartate Aminotransferase (>3*ULN)n=6 Participants0-
MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mgBilirubin (>2.0 mg/dL, >34.2 umol/L)n=6 Participants0-
Creatine Kinase (>5*ULN)n=6 Participants0-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=6 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=6 Participants16.7-
Aspartate Aminotransferase (>3*ULN)n=6 Participants0-
MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mgBilirubin (>2.0 mg/dL, >34.2 umol/L)n=6 Participants0-
Creatine Kinase (>5*ULN)n=6 Participants0-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=6 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=6 Participants0-
Aspartate Aminotransferase (>3*ULN)n=6 Participants0-
MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mgBilirubin (>2.0 mg/dL, >34.2 umol/L)n=6 Participants0-
Creatine Kinase (>5*ULN)n=6 Participants0-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=6 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=6 Participants0-
Aspartate Aminotransferase (>3*ULN)n=6 Participants0-
MRD: Placebo Cohorts 13-15Bilirubin (>2.0 mg/dL, >34.2 umol/L)n=3 Participants0-
Creatine Kinase (>5*ULN)n=3 Participants0-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=3 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=3 Participants0-
Aspartate Aminotransferase (>3*ULN)n=3 Participants0-
MRD: Cohort 13: TAK-071 3 mgBilirubin (>2.0 mg/dL, >34.2 umol/L)n=5 Participants0-
Creatine Kinase (>5*ULN)n=5 Participants0-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=5 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=5 Participants0-
Aspartate Aminotransferase (>3*ULN)n=5 Participants0-
MRD: Cohort 14: TAK-071 9 mgBilirubin (>2.0 mg/dL, >34.2 umol/L)n=5 Participants0-
Creatine Kinase (>5*ULN)n=5 Participants0-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=5 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=5 Participants0-
Aspartate Aminotransferase (>3*ULN)n=5 Participants0-
MRD: Cohort 15: TAK-071 15 mgBilirubin (>2.0 mg/dL, >34.2 umol/L)n=5 Participants0-
Creatine Kinase (>5*ULN)n=5 Participants0-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=5 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=5 Participants0-
Aspartate Aminotransferase (>3*ULN)n=5 Participants0-
Bioavailability (BA)/Food Effect: Cohort 17 Regimen ABilirubin (>2.0 mg/dL, >34.2 umol/L)n=12 Participants0-
Creatine Kinase (>5*ULN)n=12 Participants8.3-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=12 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=12 Participants0-
Aspartate Aminotransferase (>3*ULN)n=12 Participants0-
BA/Food Effect: Cohort 17 Regimen BBilirubin (>2.0 mg/dL, >34.2 umol/L)n=12 Participants0-
Creatine Kinase (>5*ULN)n=12 Participants0-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=12 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=12 Participants0-
Aspartate Aminotransferase (>3*ULN)n=12 Participants0-
BA/Food Effect: Cohort 17 Regimen CBilirubin (>2.0 mg/dL, >34.2 umol/L)n=12 Participants0-
Creatine Kinase (>5*ULN)n=12 Participants8.3-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=12 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=12 Participants0-
Aspartate Aminotransferase (>3*ULN)n=12 Participants8.3-
SRD: Cohort 18: TAK-071 120 mgBilirubin (>2.0 mg/dL, >34.2 umol/L)n=6 Participants0-
Creatine Kinase (>5*ULN)n=6 Participants0-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=6 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=6 Participants0-
Aspartate Aminotransferase (>3*ULN)n=6 Participants0-
SRD: Cohort 19: TAK-071 160 mgBilirubin (>2.0 mg/dL, >34.2 umol/L)n=6 Participants0-
Creatine Kinase (>5*ULN)n=6 Participants0-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=6 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=6 Participants0-
Aspartate Aminotransferase (>3*ULN)n=6 Participants0-
SRD: TAK-071 Placebo+Donepezil PlaceboBilirubin (>2.0 mg/dL, >34.2 umol/L)n=9 Participants0-
Creatine Kinase (>5*ULN)n=9 Participants0-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=9 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=9 Participants0-
Aspartate Aminotransferase (>3*ULN)n=9 Participants0-
SRD: TAK-071 Placebo+DonepezilBilirubin (>2.0 mg/dL, >34.2 umol/L)n=9 Participants0-
Creatine Kinase (>5*ULN)n=9 Participants0-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=9 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=9 Participants0-
Aspartate Aminotransferase (>3*ULN)n=9 Participants0-
SRD: Cohort 20: TAK-071 40 mg+DonepezilBilirubin (>2.0 mg/dL, >34.2 umol/L)n=5 Participants0-
Creatine Kinase (>5*ULN)n=5 Participants0-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=5 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=5 Participants0-
Aspartate Aminotransferase (>3*ULN)n=5 Participants0-
SRD: Cohort 21: TAK-071 60 mg+DonepezilBilirubin (>2.0 mg/dL, >34.2 umol/L)n=6 Participants0-
Creatine Kinase (>5*ULN)n=6 Participants0-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=6 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=6 Participants0-
Aspartate Aminotransferase (>3*ULN)n=6 Participants0-
SRD: Cohort 22: TAK-071 80 mg+DonepezilBilirubin (>2.0 mg/dL, >34.2 umol/L)n=6 Participants0-
Creatine Kinase (>5*ULN)n=6 Participants0-
Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L)n=6 Participants0-
Prothrombin Intl. Normalized Ratio (>1.5*ULN)n=6 Participants0-
Aspartate Aminotransferase (>3*ULN)n=6 Participants0-
Secondary/protocol endpoint/low confidence

AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

concentration, descriptive

Secondary/protocol endpoint/low confidence

AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese Participants

Time frame:Pre-dose on Day 1 and multiple timepoints (up to 24 hrs) post-dose for Cohorts 7 and 8 and Pre-dose on Day 1 and multiple timepoints (up to 96 hrs) post-dose for Cohort 9

concentration, descriptive

Secondary/protocol endpoint/low confidence

AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Japanese Participants

Time frame:Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose and Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Secondary/protocol endpoint/low confidence

AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese

Time frame:Pre-dose on Day 1 and at multiple time points (up to 24 hours) post-dose

concentration, descriptive

Secondary/protocol endpoint/low confidence

AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 Relative Bioavailability and Food Effect

Time frame:Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose

concentration, descriptive

Secondary/protocol endpoint/low confidence

AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil

Time frame:Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose

concentration, descriptive

Secondary/protocol endpoint/low confidence

CL/F: Apparent Clearance After Extravascular Administration for TAK-071 SRD Non-Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

ratio, descriptive

Secondary/protocol endpoint/low confidence

CL/F: Apparent Clearance After Extravascular Administration for TAK-071 Relative Bioavailability and Food Effect

Time frame:Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose

ratio, descriptive

Secondary/protocol endpoint/low confidence

CL/F: Apparent Clearance After Extravascular Administration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil

Time frame:Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

ratio, descriptive

Secondary/protocol endpoint/low confidence

Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 SRD Non-Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

ratio, descriptive

Secondary/protocol endpoint/low confidence

Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 Relative Bioavailability and Food Effect

Time frame:Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose

ratio, descriptive

Secondary/protocol endpoint/low confidence

Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 SRD Non-Japanese Participants TAK-071 + Donepezil

Time frame:Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

ratio, descriptive

Secondary/protocol endpoint/low confidence

AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points [up to 96 hours] post-dose

descriptive

Secondary/protocol endpoint/low confidence

AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Non-Japanese Participants

Time frame:Pre-dose on Day 1 and 21 and at multiple time points (up to 24 hours) post-dose for Cohorts 7 and 8, and pre-dose on Day 1 and 28 and multiple time points (up to 96 hours) post-dose for Cohort 9

descriptive

Secondary/protocol endpoint/low confidence

AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points (up to 96 hours) post-dose and pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose

descriptive

Secondary/protocol endpoint/low confidence

Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points (up to 96 hours) post-dose

descriptive

Secondary/protocol endpoint/low confidence

Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Non-Japanese Participants

Time frame:Pre-dose on Days 1 and 21 and at multiple time points (up to 24 hours) post-dose for Cohorts 7 and 8 and Pre-dose on Days 1 and 28 and multiple time points (up to 96 hours) post-dose for Cohort 9

descriptive

Secondary/protocol endpoint/low confidence

Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points (up to 96 hours) post-dose and pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose

descriptive

Secondary/protocol endpoint/low confidence

CLR: Renal Clearance for TAK-071 SRD Non-Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points [up to 96 hours] post-dose

descriptive

Secondary/protocol endpoint/low confidence

CLR: Renal Clearance for TAK-071 MRD Non-Japanese Participants

Time frame:Pre-dose on Days 1 and 21 and at multiple time points (up to 24 hours) post-dose for Cohorts 7 and 8 and Pre-dose on Days 1 and 28 multiple time points (up to 96 hours) post-dose for Cohort 9

descriptive

Secondary/protocol endpoint/low confidence

CLR: Renal Clearance for TAK-071 MRD Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points (up to 96 hours) post-dose and pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose

descriptive

Secondary/registry result/low confidence

AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), h*ng/mLStandard deviation
SRD: Cohort 1: TAK-071 1 mgn=6 Participants1220397.35
SRD: Cohort 2: TAK-071 3 mgn=6 Participants39451784.9
SRD: Cohort 3: TAK-071 9 mgn=6 Participants124502466.5
SRD: Cohort 4: TAK-071 20 mgn=6 Participants260103656.6
SRD: Cohort 5: TAK-071 40 mgn=6 Participants4024023644
SRD: Cohort 6: TAK-071 80 mgn=6 Participants9035013944
SRD: Cohort 18: TAK-071 120 mgn=6 Participants11170031926
SRD: Cohort 19: TAK-071 160 mgn=6 Participants13300045126
Secondary/registry result/low confidence

AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese Participants

Time frame:Pre-dose on Day 1 and multiple timepoints (up to 24 hrs) post-dose for Cohorts 7 and 8 and Pre-dose on Day 1 and multiple timepoints (up to 96 hrs) post-dose for Cohort 9

concentration, descriptive

Posted result

GroupValue (mean), h*ng/mLStandard deviation
MRD: Cohort 7: TAK-071 3 mgn=6 Participants1347302.98
MRD: Cohort 8: TAK-071 9 mgn=6 Participants3550765.01
MRD: Cohort 9: TAK-071 15 mgn=6 Participants168804514.9
Secondary/registry result/low confidence

AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Japanese Participants

Time frame:Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose and Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), h*ng/mLStandard deviation
MRD: Cohort 13: TAK-071 3 mgDay 1n=5 Participants3773968.76
Day 8n=5 Participants1529344.00
MRD: Cohort 14: TAK-071 9 mgDay 1n=5 Participants119302764.4
Day 8n=5 Participants4634787.02
MRD: Cohort 15: TAK-071 15 mgDay 1n=5 Participants157903273.2
Day 8n=5 Participants61101217.2
Secondary/registry result/low confidence

AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese

Time frame:Pre-dose on Day 1 and at multiple time points (up to 24 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), h*ng/mLStandard deviation
MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mgn=6 Participants1442251.62
MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mgn=6 Participants3636286.83
MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mgn=6 Participants5832921.06
Secondary/registry result/low confidence

AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 Relative Bioavailability and Food Effect

Time frame:Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), h*ng/mLStandard deviation
Bioavailability (BA)/Food Effect: Cohort 17 Regimen An=12 Participants142103392.5
BA/Food Effect: Cohort 17 Regimen Bn=12 Participants132602983.9
BA/Food Effect: Cohort 17 Regimen Cn=12 Participants146103324.3
Secondary/registry result/low confidence

AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil

Time frame:Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose

concentration, descriptive

Posted result

GroupValue (mean), h*ng/mLStandard deviation
SRD: Cohort 20: TAK-071 40 mg+Donepeziln=3 Participants8565013013
SRD: Cohort 21: TAK-071 60 mg+Donepeziln=6 Participants4597010798
SRD: Cohort 22: TAK-071 80 mg+Donepeziln=5 Participants410704387.9
Secondary/registry result/low confidence

CL/F: Apparent Clearance After Extravascular Administration for TAK-071 SRD Non-Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

ratio, descriptive

Posted result

GroupValue (mean), L/hStandard deviation
SRD: Cohort 1: TAK-071 1 mgn=6 Participants0.72220.36130
SRD: Cohort 2: TAK-071 3 mgn=6 Participants0.79980.36546
SRD: Cohort 3: TAK-071 9 mgn=6 Participants0.64940.24348
SRD: Cohort 4: TAK-071 20 mgn=6 Participants0.66440.12027
SRD: Cohort 5: TAK-071 40 mgn=6 Participants3.8447.3558
SRD: Cohort 6: TAK-071 80 mgn=6 Participants0.77620.13868
SRD: Cohort 18: TAK-071 120 mgn=6 Participants1.0080.36826
SRD: Cohort 19: TAK-071 160 mgn=6 Participants1.1410.45838
Secondary/registry result/low confidence

CL/F: Apparent Clearance After Extravascular Administration for TAK-071 Relative Bioavailability and Food Effect

Time frame:Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose

ratio, descriptive

Posted result

GroupValue (mean), L/hStandard deviation
Bioavailability (BA)/Food Effect: Cohort 17 Regimen An=12 Participants0.69250.27468
BA/Food Effect: Cohort 17 Regimen Bn=12 Participants0.72320.26191
BA/Food Effect: Cohort 17 Regimen Cn=12 Participants0.66630.25695
Secondary/registry result/low confidence

CL/F: Apparent Clearance After Extravascular Administration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil

Time frame:Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

ratio, descriptive

Posted result

GroupValue (mean), L/hStandard deviation
SRD: Cohort 20: TAK-071 40 mg+Donepeziln=3 Participants0.84530.17228
SRD: Cohort 21: TAK-071 60 mg+Donepeziln=6 Participants1.3040.34484
SRD: Cohort 22: TAK-071 80 mg+Donepeziln=5 Participants0.87420.11009
Secondary/registry result/low confidence

Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 SRD Non-Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

ratio, descriptive

Posted result

GroupValue (mean), LStandard deviation
SRD: Cohort 1: TAK-071 1 mgn=6 Participants43.6310.532
SRD: Cohort 2: TAK-071 3 mgn=6 Participants44.965.7176
SRD: Cohort 3: TAK-071 9 mgn=6 Participants48.109.0985
SRD: Cohort 4: TAK-071 20 mgn=6 Participants54.629.8917
SRD: Cohort 5: TAK-071 40 mgn=6 Participants321.0656.95
SRD: Cohort 6: TAK-071 80 mgn=6 Participants59.5411.499
SRD: Cohort 18: TAK-071 120 mgn=6 Participants70.259.1042
SRD: Cohort 19: TAK-071 160 mgn=6 Participants84.4716.851
Secondary/registry result/low confidence

Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 Relative Bioavailability and Food Effect

Time frame:Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose

ratio, descriptive

Posted result

GroupValue (mean), LStandard deviation
Bioavailability (BA)/Food Effect: Cohort 17 Regimen An=12 Participants44.437.1688
BA/Food Effect: Cohort 17 Regimen Bn=12 Participants46.747.3595
BA/Food Effect: Cohort 17 Regimen Cn=12 Participants43.826.3235
Secondary/registry result/low confidence

Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 SRD Non-Japanese Participants TAK-071 + Donepezil

Time frame:Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

ratio, descriptive

Posted result

GroupValue (mean), LStandard deviation
SRD: Cohort 20: TAK-071 40 mg+Donepeziln=3 Participants59.035.5208
SRD: Cohort 21: TAK-071 60 mg+Donepeziln=6 Participants62.4017.164
SRD: Cohort 22: TAK-071 80 mg+Donepeziln=5 Participants63.5211.895
Secondary/registry result/low confidence

AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points [up to 96 hours] post-dose

descriptive

Posted result

GroupValue (mean), mgStandard deviation
SRD: Cohort 2: TAK-071 3 mgn=5 Participants0.0017310.0015806
SRD: Cohort 3: TAK-071 9 mgn=6 Participants0.016320.0062545
SRD: Cohort 4: TAK-071 20 mgn=6 Participants0.057530.023868
SRD: Cohort 5: TAK-071 40 mgn=6 Participants0.085590.052157
SRD: Cohort 6: TAK-071 80 mgn=5 Participants0.090520.044805
SRD: Cohort 18: TAK-071 120 mgn=6 Participants0.16520.097242
SRD: Cohort 19: TAK-071 160 mgn=6 Participants0.15050.10905
Secondary/registry result/low confidence

AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Non-Japanese Participants

Time frame:Pre-dose on Day 1 and 21 and at multiple time points (up to 24 hours) post-dose for Cohorts 7 and 8, and pre-dose on Day 1 and 28 and multiple time points (up to 96 hours) post-dose for Cohort 9

descriptive

Posted result

GroupValue (mean), mgStandard deviation
MRD: Cohort 7: TAK-071 3 mgDay 1n=6 Participants0.0015010.0017987
Day 21n=6 Participants0.0090660.0042349
MRD: Cohort 8: TAK-071 9 mgDay 1n=6 Participants0.0059730.0034636
Day 21n=6 Participants0.023930.014412
MRD: Cohort 9: TAK-071 15 mgDay 1n=6 Participants0.049290.019263
Day 28n=5 Participants0.11190.079021
Secondary/registry result/low confidence

AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points (up to 96 hours) post-dose and pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose

descriptive

Posted result

GroupValue (mean), mgStandard deviation
MRD: Cohort 13: TAK-071 3 mgDay 1n=5 Participants0.0034360.0031125
Day 28n=5 Participants0.012020.010480
MRD: Cohort 14: TAK-071 9 mgDay 1n=5 Participants0.020830.0094853
Day 28n=5 Participants0.033940.022682
MRD: Cohort 15: TAK-071 15 mgDay 1n=5 Participants0.032240.023202
Day 28n=5 Participants0.064820.062816
Secondary/registry result/low confidence

Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points (up to 96 hours) post-dose

descriptive

Posted result

GroupValue (mean), fraction of drug excretedStandard deviation
SRD: Cohort 2: TAK-071 3 mgn=5 Participants0.057710.052687
SRD: Cohort 3: TAK-071 9 mgn=6 Participants0.18130.069494
SRD: Cohort 4: TAK-071 20 mgn=6 Participants0.28770.11934
SRD: Cohort 5: TAK-071 40 mgn=6 Participants0.21400.13039
SRD: Cohort 6: TAK-071 80 mgn=5 Participants0.11310.056006
SRD: Cohort 18: TAK-071 120 mgn=6 Participants0.13770.081035
SRD: Cohort 19: TAK-071 160 mgn=6 Participants0.094080.068159
Secondary/registry result/low confidence

Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Non-Japanese Participants

Time frame:Pre-dose on Days 1 and 21 and at multiple time points (up to 24 hours) post-dose for Cohorts 7 and 8 and Pre-dose on Days 1 and 28 and multiple time points (up to 96 hours) post-dose for Cohort 9

descriptive

Posted result

GroupValue (mean), fraction of drug excretedStandard deviation
MRD: Cohort 7: TAK-071 3 mgDay 1n=6 Participants0.050030.059956
Day 21n=6 Participants0.30220.14116
MRD: Cohort 8: TAK-071 9 mgDay 1n=6 Participants0.066360.038484
Day 21n=6 Participants0.26590.16013
MRD: Cohort 9: TAK-071 15 mgDay 1n=6 Participants0.32860.12842
Day 28n=5 Participants0.74600.52680
Secondary/registry result/low confidence

Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points (up to 96 hours) post-dose and pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose

descriptive

Posted result

GroupValue (mean), fraction of drug excretedStandard deviation
MRD: Cohort 13: TAK-071 3 mgDay 1n=5 Participants0.11450.10375
Day 28n=5 Participants0.40050.34935
MRD: Cohort 14: TAK-071 9 mgDay 1n=5 Participants0.23140.10539
Day 28n=5 Participants0.37710.25202
MRD: Cohort 15: TAK-071 15 mgDay 1n=5 Participants0.21500.15468
Day 28n=5 Participants0.43210.41878
Secondary/registry result/low confidence

CLR: Renal Clearance for TAK-071 SRD Non-Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points [up to 96 hours] post-dose

descriptive

Posted result

GroupValue (mean), L/hStandard deviation
SRD: Cohort 2: TAK-071 3 mgn=5 Participants0.00063540.00072647
SRD: Cohort 3: TAK-071 9 mgn=6 Participants0.0016680.00058267
SRD: Cohort 4: TAK-071 20 mgn=6 Participants0.0027750.00098052
SRD: Cohort 5: TAK-071 40 mgn=6 Participants0.0024530.0015795
SRD: Cohort 6: TAK-071 80 mgn=5 Participants0.0014250.00071797
SRD: Cohort 18: TAK-071 120 mgn=6 Participants0.0018700.0010016
SRD: Cohort 19: TAK-071 160 mgn=6 Participants0.0016960.0015594
Secondary/registry result/low confidence

CLR: Renal Clearance for TAK-071 MRD Non-Japanese Participants

Time frame:Pre-dose on Days 1 and 21 and at multiple time points (up to 24 hours) post-dose for Cohorts 7 and 8 and Pre-dose on Days 1 and 28 multiple time points (up to 96 hours) post-dose for Cohort 9

descriptive

Posted result

GroupValue (mean), L/hStandard deviation
MRD: Cohort 7: TAK-071 3 mgDay 1n=6 Participants0.0011330.0015553
Day 21n=6 Participants0.0019370.00099073
MRD: Cohort 8: TAK-071 9 mgDay 1n=6 Participants0.0016860.00092928
Day 21n=6 Participants0.0019910.0012947
MRD: Cohort 9: TAK-071 15 mgDay 1n=6 Participants0.0031630.0016448
Day 28n=5 Participants0.0054310.0032772
Secondary/registry result/low confidence

CLR: Renal Clearance for TAK-071 MRD Japanese Participants

Time frame:Pre-dose on Day 1 and at multiple time points (up to 96 hours) post-dose and pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose

descriptive

Posted result

GroupValue (mean), L/hStandard deviation
MRD: Cohort 13: TAK-071 3 mgDay 1n=5 Participants0.00086410.00063849
Day 28n=5 Participants0.0024940.0014594
MRD: Cohort 14: TAK-071 9 mgDay 1n=5 Participants0.0017830.00090441
Day 28n=5 Participants0.0026800.0019001
MRD: Cohort 15: TAK-071 15 mgDay 1n=5 Participants0.0020930.0016105
Day 28n=5 Participants0.0034260.0021244

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.