NCT05434091

A First-In-Human Study of the Study Medicine, Called PF-07291177, in Healthy Adult Participants

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED, 4-PERIOD, CROSSOVER, FIRST-IN-HUMAN STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE ASCENDING ORAL DOSES OF PF 07291177 ADMINISTERED TO HEALTHY ADULT PARTICIPANTS

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to learn about the safety, tolerability (the extent to which side effects can be tolerated), and plasma pharmacokinetics (PK) (PK helps us understand how the drug is changed and eliminated from body after you take it) of PF-07291177 after administration of escalating, single, doses by mouth.

Detailed description

The purpose of the study is to learn about the safety, the extent to which side effects can be tolerated, and plasma pharmacokinetics (PK) (PK helps us understand how the drug is changed and eliminated from your body after you take it) of PF-07291177 after administration of escalating, single, doses by mouth. Each participant in this study is planned to undergo up to 4 treatment periods receiving up to 3 doses of PF 07291177 and 1 dose of placebo. Precautionary sentinel dosing will be used in this study. Two participants (1 receiving PF 07291177 and 1 receiving placebo) within a period will be dosed initially before the remaining participants of that period are dosed. This study is seeking : * Female participants of non-child bearing potential and males must be 18 to 60 years of age, inclusive, at the time of signing the ICD * Female participants of non-child bearing potential and males who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	PF-07291177	PF-07291177 will be prepared as an oral solution and/or suspension given in escalating single doses to be determined
DRUG	Placebo	Matching placebo will be prepared as an oral solution and/or suspension given in each cohort

Timeline

• Start date: 2022-08-15
• Primary completion: 2023-03-29
• Completion: 2023-03-29
• First posted: 2022-06-27
• Last updated: 2022-09-07

Regulatory

• FDA-regulated drug study