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A Study to Learn How Different Amounts of the Study Medicine Called PF-08161842 Are Tolerated and Act in the Body in Healthy and Older Adults
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED, DOSE ESCALATING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE AND MULTIPLE ORAL DOSES OF PF-08161842 IN HEALTHY AND OLDER PARTICIPANTS
Lead sponsor
Asset
PF-08161842
Listed sites
0
Recruiting sites
-
Enrollment
98
estimated
Study population
Alzheimer’s disease
Key I/E criterion
•Age 18-85
Primary endpoints
•Treatment Emergent Adverse Events (TEAEs)•Serious Adverse Events (SAEs)•Clinically Significant Laboratory Abnormalities
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Healthy adults, ages 18 to 64 years and healthy older adults, ages 65 to 85 years.
2. Body mass index (BMI) of 16-32 kg/m2; and a total body weight >50kg (110 lb.)
Exclusion criteria
1. Evidence or history of clinically significant medical conditions.
2. Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
3. A positive urine drug test.
Endpoints (13)
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
Fluid / digital biomarkers
1 endpointCerebrospinal Fluid (CSF) Concentration of PF-08161842
Time frame:Part A: At day 2 post dose Part B: At day 15 post dose
concentration, descriptive
Safety / tolerability / PK
9 endpointsNumber of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame:From first dose through approximately 28 to 35 days after the last dose
event count, event
Number of Participants With Serious Adverse Events (SAEs)
Time frame:From first dose through approximately 28 to 35 days after the last dose
event count, event
Number of Participants With Clinically Significant Vital Signs Abnormalities
Time frame:From first dose through approximately 28 to 35 days after the last dose
event count, event
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Time frame:From first dose through approximately 28 to 35 days after the last dose
event count, event
Number of Participants With Clinically Significant Columbia-Suicidality Severity Rating Scale (C-SSRS)
Time frame:From first dose through approximately 28 to 35 days after the last dose
event count, event
Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)
Time frame:Part A only: Up to Day 5
concentration, descriptive
Maximum Observed Plasma Concentration (Cmax)
Time frame:Part A: Up to Day 5 Part B: Up to Day 17
concentration, descriptive
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame:Part A: Up to Day 5 Part B: Up to Day 17
time to event, event
Plasma Decay Half-life (t1/2) if data permit
Time frame:Part A only: Up to Day 5
concentration, descriptive
Other (unclassified)
3 endpointsNumber of Participants With Clinically Significant Laboratory Abnormalities
Time frame:From first dose through approximately 28 to 35 days after the last dose
event count, event
Area Under the Curve From Time Zero to end of Dosing Interval (AUCtau)
Time frame:Part B only: Up to Day 17
descriptive
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) if data permit
Time frame:Part A only: Up to Day 5
descriptive
Provenance
Sources
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 November 5, 2026 snapshot.