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

NCT07015918 | Completed Phase 1 FDA Drug

• 2 other identifiers: C55410022024-518535-11-00
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Male Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants with treatment emergent adverse events

  First dose (Day 1) through 28 to 35 days after final dose (approximately 12 weeks)

Study Arms (1)

Arm 1

EXPERIMENTAL

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

Drug: [14C] PF-07976016; Drug: PF-07976016

Interventions

[14C] PF-07976016 DRUG

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

Arm 1

PF-07976016 DRUG

PF-07976016 liquid (oral) formulation

Arm 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Healthy male participants
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

ICON

Groningen, 9728 NZ, Netherlands

Location

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: June 4, 2025
• Primary Completion: July 16, 2025
• Study Completion: August 14, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)