A Study to Understand How the Study Medicine (PF-07976016) is Processed and Eliminated in Healthy Men

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-04

Study Completion Date

2025-08-14

Brief Summary

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The purpose of this study is to learn about how much the study medicine PF-07976016 will be taken up and processed by healthy male participants. The total number of weeks of the study is up to approximately 12 weeks.

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Detailed Description

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Conditions

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Healthy Male Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Arm 1

Participants will receive doses of PF-07976016 with and without radiolabel.

Group Type EXPERIMENTAL

[14C] PF-07976016

Intervention Type DRUG

\[14C\] PF-07976016 liquid (oral) formulation

PF-07976016

Intervention Type DRUG

PF-07976016 liquid (oral) formulation

[14C] PF-07976016

Intervention Type DRUG

\[14C\] PF-07976016 intravenous (IV) formulation

Interventions

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[14C] PF-07976016

\[14C\] PF-07976016 liquid (oral) formulation

Intervention Type DRUG

PF-07976016

PF-07976016 liquid (oral) formulation

Intervention Type DRUG

[14C] PF-07976016

\[14C\] PF-07976016 intravenous (IV) formulation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males, 18 to 65 years of age
* BMI 17.5 to 32 kg/m2 and a total body weight \>50 kg (110 lb)
* Willing and able to comply with all study procedures

Exclusion Criteria

* History of irregular bowel movements or lactose intolerance
* Any medical or psychiatric condition or laboratory abnormality or other condition that may increase the risk of study participation
* Use of any prohibited or concomitant medication(s)
* Presence of specified abnormalities on diagnostic assessments including clinical laboratory tests
* Positive urine drug test
* History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence
* Use of tobacco/nicotine containing products in excess of the equivalent of 5 cigarettes/day
* Previous administration of an investigational product within 30 days preceding the first dose of study medicine in this study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes