NCT06392230

A Study to Learn How the Medicine Called [14C] PF-06821497 is Taken up Into and Removed From the Body.

A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE, 2-PERIOD STUDY IN HEALTHY ADULT MALE PARTICIPANTS TO ASSESS THE MASS BALANCE, ABSOLUTE BIOAVAILABILITY, FRACTION ABSORBED, AND PHARMACOKINETICS OF [14C]PF-06821497 USING A 14C-MICROTRACER APPROACH

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

Summary

The purpose of this study is to learn how a certain amount of \[14C\] PF-06821497 is taken up into the bloodstream and removed from the body. The study is seeking participants who are: * Males aged 18 years or older. * Are confirmed to be healthy after performing some medical and physical tests. * Weigh more than 50 kilograms and have a body mass index of 16 to 32 kg per meter squared. The study consists of two parts. In part one, all participants will receive one full dose of \[14C\]PF-06821497 by mouth. Part two will begin at least 14 days after the dose in part one. In part two participants will receive one full dose of PF-06821497 by mouth and one small dose of \[14C\]PF-06821497 by intravenous (IV) infusion. IV infusion will be directly injected into the veins. To understand how the medicine is processed in the body, samples of blood, urine, and feces will be collected after each dose is given. This will help understand: * How much PF-06821497 is taken up into the bloodstream when taken by mouth compared to the dose given by IV * How the body removes it from the bloodstream. Participants will take part in the study for about 11 weeks, including the initial evaluation and follow-up periods.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Oral [14C] PF-06821497	A single oral dose of \[14C\] PF-06821497 will be administered as an extemporaneous suspension in Period 1
DRUG	Oral PF-06821497	A single oral dose of PF-06821497 will be administered as an extemporaneous oral suspension in Period 2
DRUG	IV [14C] PF-06821497	A single IV infusion of \[14C\] PF-06821497 will be administered at the Tmax after administration of the unlabeled oral dose of PF-06821497 in Period 2

Timeline

• Start date: 2024-08-30
• Primary completion: 2024-11-11
• Completion: 2024-11-11
• First posted: 2024-04-30
• Last updated: 2025-01-23

Locations

1 site across 1 country: Netherlands