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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-15

Study Completion Date

2023-03-29

Brief Summary

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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.

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Detailed Description

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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

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-07291177 and Placebo (Cohort 1)

Single dose administration of PF-07291177 and placebo; Within a cohort, participants will receive 3 doses of PF-07291177 and 1 dose of placebo.

Group Type EXPERIMENTAL

PF-07291177

Intervention Type DRUG

PF-07291177 will be prepared as an oral solution and/or suspension given in escalating single doses to be determined

Placebo

Intervention Type DRUG

Matching placebo will be prepared as an oral solution and/or suspension given in each cohort

PF-07291177 and Placebo (Cohort 2)

Single dose administration of PF-07291177 and placebo; Within a cohort, participants will receive 3 doses of PF-07291177 and 1 dose of placebo.

Group Type EXPERIMENTAL

PF-07291177

Intervention Type DRUG

PF-07291177 will be prepared as an oral solution and/or suspension given in escalating single doses to be determined

Placebo

Intervention Type DRUG

Matching placebo will be prepared as an oral solution and/or suspension given in each cohort

PF-07291177 and Placebo (Cohort 3)

Single dose administration of PF-07291177 and placebo; Within a cohort, participants will receive 3 doses of PF-07291177 and 1 dose of placebo.

Group Type EXPERIMENTAL

PF-07291177

Intervention Type DRUG

PF-07291177 will be prepared as an oral solution and/or suspension given in escalating single doses to be determined

Placebo

Intervention Type DRUG

Matching placebo will be prepared as an oral solution and/or suspension given in each cohort

Interventions

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PF-07291177

PF-07291177 will be prepared as an oral solution and/or suspension given in escalating single doses to be determined

Intervention Type DRUG

Placebo

Matching placebo will be prepared as an oral solution and/or suspension given in each cohort

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

10. History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit, or 3 ounces (90 mL) of wine).
11. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes