A Study to Learn How Different Amounts of the Study Medicine Called PF-07940369 Are Tolerated and Act in the Body in Healthy Adults.
NCT Number: NCT06532383
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy
Interventions: DRUG: PF-07940369|DRUG: Placebo
Sponsor: Pfizer
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-06
Completion Date: 2025-03-27
Locations: Pfizer Clinical Research Unit - Brussels, Brussels, Bruxelles-capitale, Région DE, B-1070, Belgium

Summary:
The purpose of the study is to evaluate the safety, tolerability, and Pharmacokinetics (Pharmacokinetics \[PK\] to better understand how the drug is changed and eliminated from your body after you take it) of single ascending oral doses of PF-07940369 in healthy adult participants.

This study is seeking participants who:

* are male or female that are not of childbearing potential of 18 years of age or older
* are examined to be healthy

All participants will receive up to 4 single doses of PF-07940369 and up to 2 placebo doses. All treatments will be taken by mouth.

All participants will remain in the study clinic for 4 days for each treatment, for safety review, laboratory collections, and to collect samples for PK.

All participants selected in the study will be required to go through a screening period up to 28 days. A screening period is the time during which a few participants are examined to see whether they are fit for the study. During this period, the participant's medical history and past and current medications will be reviewed. A series of tests will also be performed to see if they are good to be selected for the study. If the participant meets all required criteria and are interested in continuing, the participant will be brought into the study clinic to stay overnight for 4 days for each treatment period. On day 4, the participant will be discharged. About 28 to 35 days after discharge following the final treatment, the participant will be contacted for a follow up visit either in person or by telephone. This is to check up on how the participant is doing and to conclude the study.

Primary Outcome Measures: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs), Baseline (Day 0) up to 35 days after last dose of study medication|Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities, Baseline up to Day 4|Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Baseline up to Day 4|Number of Participants With Clinically Significant Change From Baseline in Telemetry Findings, Baseline up to Day 4|Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings, Baseline up to Day 4
Secondary Outcome Measures: Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-07940369, Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period|Maximum Observed Plasma Concentration (Cmax) of PF-07940369, Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07940369, Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07940369, Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period|Plasma Half-Life (t1/2) of PF-07940369, Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period