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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07015918

Enrollment

Registered

2025-06-11

Start date

2025-06-04

Completion date

2025-08-14

Last updated

2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Male Volunteers

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.

Interventions

DRUG[14C] PF-07976016

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

DRUGPF-07976016

PF-07976016 liquid (oral) formulation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026