NCT06532383

A Study to Learn How Different Amounts of the Study Medicine Called PF-07940369 Are Tolerated and Act in the Body in Healthy Adults.

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBOCONTROLLED, SINGLE-DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-07940369 IN HEALTHY ADULT PARTICIPANTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	PF-07940369	Bulk powder for extemporaneous preparation for oral solutions.
DRUG	Placebo	Bulk powder for extemporaneous preparation for oral solutions

Timeline

• Start date: 2024-08-14
• Primary completion: 2025-01-16
• Completion: 2025-01-16
• First posted: 2024-08-01
• Last updated: 2025-08-28

Locations

1 site across 1 country: Belgium