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OpenTrials
Completed

NCT Number: NCT07015918

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

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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Key information

Conditions

Healthy Male Volunteers

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

ICON

Groningen, 9728 NZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[14C] PF-07976016

Drug

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

PF-07976016

Drug

PF-07976016 liquid (oral) formulation

Primary outcomes

  1. Total recovery of radioactivity expressed as a percent of total oral radioactive dose administered.

    Time frame: From dose (Day 1) and for up to 21 days thereafter

Secondary outcomes

  1. Number of participants with treatment emergent adverse events

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 1, OPEN-LABEL, 2-PERIOD, FIXED-SEQUENCE STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM, AND EXCRETION OF [14C]PF-07976016 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-07976016 IN HEALTHY MALE PARTICIPANTS USING A [14C]-MICROTRACER APPROACH

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 11, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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