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

Phase 1

Recruiting

• Conditions: Healthy Male Volunteers
• Interventions: Drug: [14C] PF-07976016; Drug: PF-07976016

• Registration Number: NCT07015918
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-03
• Study First Submitted QC: 2025-06-03
• Study Start: 2025-06-04
• Study First Posted: 2025-06-11
• Last Update Submitted: 2025-06-17
• Last Update Posted: 2025-06-22
• Primary Completion: 2025-08-13
• Study Completion: 2025-08-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	[14C] PF-07976016	Participants will receive doses of PF-07976016 with and without radiolabel.
Arm 1	PF-07976016	Participants will receive doses of PF-07976016 with and without radiolabel.

Primary Outcome Measures

Name	Time	Method
Total recovery of radioactivity expressed as a percent of total oral radioactive dose administered.	From dose (Day 1) and for up to 21 days thereafter

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment emergent adverse events	First dose (Day 1) through 28 to 35 days after final dose (approximately 12 weeks)

Trial Locations

Locations (1)

ICON; 🇳🇱 Groningen, Netherlands