NCT05652647

A Study to Understand How the Study Medicine (PF-07081532) 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-07081532 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-07081532 IN HEALTHY MALE PARTICIPANTS USING A [14C]-MICROTRACER APPROACH

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Pfizer · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this clinical trial is to learn about how much PF-07081532 will be taken up and processed by healthy male participants. The study consists of two parts, called study periods. In Period 1, participants will take one dose of PF-07081532 by mouth. In Period 2, participants will take one dose by mouth and one dose as an injection through a vein at the study clinic. In Period 1, participants will stay at the clinic site for up to 21 days. In Period 2, they will stay at the clinic site for 7 days. During their stays, participants will have their blood, urine, and feces collected by the study doctors several times. We will measure the level of PF-07081532 in participants' blood, urine, and feces samples. This will help us know how much the study medicine is getting taken in by the body. At the end of the study, participants will be contacted by phone to check in. Participants will be involved in this study for about 12 weeks.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Oral [14C]PF-07081532	A single oral dose of \[14C\]PF-07081532, will be administered as a liquid formulation in study period 1.
DRUG	Oral PF-07081532 and IV [14C]PF-07081532	In study period 2: a single, oral, unlabeled dose of PF-07081532 will be administered as a liquid formulation. Approximately 1 hours after the administration of the unlabeled oral dose, a single dose of \[14C\]PF-07081532 will be administered via intravenous infusion.

Timeline

• Start date: 2022-12-21
• Primary completion: 2023-03-15
• Completion: 2023-03-15
• First posted: 2022-12-15
• Last updated: 2024-09-24
• Results posted: 2024-09-24

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study