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CompletedPhase 1

A Study to Determine the Metabolism and Elimination of [14C]E2027 in Healthy Male Participants

An Open-Label, Single-Dose Study to Determine the Metabolism and Elimination of [14C]E2027 in Healthy Male Subjects

Lead sponsor

Eisai Inc.

Asset

Irsenontrine

Listed sites

1

Recruiting sites

-

Enrollment

8

actual

Study population

Lewy body dementia

Key I/E criteria

Age 18-55Male

Primary endpoints

Cumulative Percent of the Radiolabeled Dose of [14C]E2027 in Biological MatricesCmax of Radiolabeled [14C]E2027, Non-Radiolabeled E2027Reach Maximum (Peak) Concentration (Tmax) of Radiolabeled [14C]E2027

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

Org study IDE2027-A001-005
NCT IDNCT04023877

Timeline

Milestones

Study first posted2019-07-18actual
Study start2019-07-18actual
Primary completion2019-10-11actual
Study completion2019-10-11actual
Last update posted2019-12-03actual

Assets

Drug assets

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexMale
Healthy volunteersAccepted

Inclusion criteria

Participants must meet all of the following criteria to be included in this study:

1. Body Mass Index (BMI) of 18 to 30 kilogram per square meter (kg/m^2) at Screening

Exclusion criteria

Participants who meet any of the following criteria will be excluded from this study:

1. Have participated in a [14C]-research study within the 6 months prior to Day -1

2. Exposure to clinically significant radiation (greater than [>] 100 millisieverts) within 12 months prior to Day -1

3. Clinically significant illness that required medical treatment within 8 weeks or a clinically significant infection that required medical treatment within 4 weeks before dosing

4. Any history of abdominal surgery that may affect pharmacokinetic profiles of study drug (example, hepatectomy, nephrectomy, digestive organ resection but not cholecystectomy nor appendectomy) at Screening or Baseline

5. Any other clinically abnormal symptom or organ impairment found by medical history, physical examinations, vital signs, ECG finding (including PR > 210 millisecond [msec], QRS > 110 msec), or laboratory test results that required medical treatment at Screening or Baseline

6. A prolonged QT/QTc interval (QTcF > 450 msec) as demonstrated by ECGs at Screening or Baseline

7. Systolic blood pressure > 130 millimetres of mercury (mmHg) or diastolic blood pressure > 85 mmHg at Screening or Baseline

8. Heart rate less than (<) 45 beats per minute (beats/min) or >100 beats/min at Screening or Baseline

9. Known history of clinically significant drug allergy at Screening or Baseline

10. Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening or Baseline

11. Known to be human immunodeficiency virus (HIV) positive at Screening

12. Active viral hepatitis (A, B, or C) as demonstrated by positive serology at Screening

13. History of drug or alcohol dependency or abuse within the 2 years before Screening, or those who have a positive urine drug or alcohol test at Screening or Baseline

14. Use of tobacco or nicotine-containing products within 4 weeks before dosing

15. Currently enrolled in another clinical trial or used any investigational drug or device within 30 days (or 5 half-lives, whichever is longer) preceding informed consent

16. Engagement in strenuous exercise within 2 weeks before dosing (example, marathon runners, weight lifters)

17. Intake of caffeinated beverages or caffeinated food within 72 hours before dosing

18. Intake of nutritional supplements, juice, and herbal preparations or other foods or beverages that may affect the various drug metabolizing enzymes and transporters (example, alcohol, grapefruit, grapefruit juice, grapefruit-containing beverages, apple or orange juice, vegetables from the mustard green family [example, kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard], and charbroiled meats) within 1 week before dosing

19. Intake of herbal preparations containing St. John's Wort within 4 weeks before dosing Intake of over-the-counter (OTC) medications within 14 days (or 5 half-lives, whichever is longer) before dosing unless the investigator and sponsor medical monitor consider that they do not compromise participant safety or study assessments

20. Use of any prescription drugs within 4 weeks before dosing

21. Use of illegal recreational drugs

22. Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week of dosing

Endpoints (15)

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
10
Other (unclassified)
5

Safety / tolerability / PK

10 endpoints
Primary/protocol endpoint

Maximum Concentration (Cmax) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices

Time frame:Pre-dose up to Day 56 post-dose

concentration, descriptive

Primary/protocol endpoint

Time to Reach Maximum (Peak) Concentration (Tmax) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices

Time frame:Pre-dose up to Day 56 post-dose

time to event, event

Primary/protocol endpoint

Area Under the Concentration-Time Curve From Time Zero to 24 hours (AUC(0-24h)) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices

Time frame:Pre-dose up to Day 56 post-dose

concentration, descriptive

Primary/protocol endpoint

Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUC(0-t)) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices

Time frame:Pre-dose up to Day 56 post-dose

concentration, descriptive

Primary/protocol endpoint

Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC(0-inf)) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices

Time frame:Pre-dose up to Day 56 post-dose

concentration, descriptive

Primary/protocol endpoint

Terminal Elimination Half-life (t1/2) of Radiolabeled [14C]E2027, Non-Radiolabeled E2027 and Metabolites in Biological Matrices

Time frame:Pre-dose up to Day 56 post-dose

concentration, descriptive

Primary/protocol endpoint

Percent of AUC(0-inf) of Metabolite to E2027 in Biological Matrices

Time frame:Pre-dose up to Day 28 post-dose

concentration, descriptive

Secondary/protocol endpoint

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:Up to 56 days post-dose

event count, event

Secondary/protocol endpoint

Number of Participants With Clinically Significant Abnormal Vital Sign Values

Time frame:Up to 56 days post-dose

event count, event

Secondary/protocol endpoint

Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings

Time frame:Up to 56 days post-dose

event count, event

Other (unclassified)

5 endpoints
Primary/protocol endpoint/low confidence

Cumulative Percent of the Radiolabeled Dose of [14C]E2027 in Biological Matrices (Blood, Urine, Feces and Toilet Tissue)

Time frame:Up to 56 days

descriptive

Primary/protocol endpoint/low confidence

Apparent Total Body Clearance (CL/F) of E2027 in Biological Matrices

Time frame:Pre-dose up to Day 56 post-dose

descriptive

Primary/protocol endpoint/low confidence

Apparent Volume of Distribution (Vd/F) of E2027 in Biological Matrices

Time frame:Pre-dose up to Day 28 post-dose

descriptive

Secondary/protocol endpoint/low confidence

Number of Participants With Clinically Significant Abnormal Laboratory Values

Time frame:Up to 56 days post-dose

event count, event

Secondary/protocol endpoint/low confidence

Number of Participants With Clinically Significant Abnormal Physical Examination Findings

Time frame:Baseline, Up to 56 days post-dose

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.