NCT07423286

A Study to Understand What the Body Does to the Study Medicine Called PF-07248144 When Taken by Healthy Adults

A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE, 2-PERIOD STUDY IN HEALTHY ADULT PARTICIPANTS TO ASSESS THE MASS BALANCE,ABSOLUTE BIOAVAILABILITY, FRACTION ABSORBED, AND PHARMACOKINETICS OF [14C]PF-07248144 USING A 14C-MICROTRACER APPROACH

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

For this study, the study medicine has been specially prepared to contain radiolabeled carbon \[14C\]. \[14C\] is a naturally occurring radioactive form of the element carbon. Adding a low dose of radiation to the study medicine does not change how the medicine works but helps to see how the medicine appears in the blood, urine, and stool after it is given. This type of study is called a radiolabeled study. The purpose of this radiolabeled study is to learn how a certain amount of \[14C\] PF-07248144 is taken up into the bloodstream and removed from the body. The study is seeking participants who are: * females who cannot have children, or males * 18 years of age or older * confirmed to be healthy based on medical and physical tests. * weigh more than 50 kilograms (kg) and have a body mass index of 18 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-07248144 by mouth. Part two will begin at least 28 days after the dose in part one. In part two, participants will receive one full dose of PF-07248144 by mouth and one small dose of \[14C\] PF-07248144 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, feces, and vomit (if any) will be collected after each dose is given. This will help understand: * How much PF-07248144 is taken up into the bloodstream when taken by mouth compared to the dose given by IV * How the body removes it from the blood steam. Participants will take part in the study for about 15 weeks, including evaluation at the start and follow-up period.

Conditions

• Healthy Adult Participants

Interventions

Type	Name	Description
DRUG	Oral [14C] PF-07248144	A single oral dose of \[14C\] PF-07248144 will be administered as an extemporaneous suspension in Period 1
DRUG	Oral unlabeled PF-07248144	A single oral dose of unlabeled PF-07248144 will be administered as tablets in Period 2
DRUG	IV [14C] PF-07248144	A single IV infusion of \[14C\] PF-07248144 will be administered at the approximate Tmax after administration of the unlabeled oral dose of PF-07248144 in Period 2

Timeline

• Start date: 2025-10-13
• Primary completion: 2025-12-28
• Completion: 2026-01-16
• First posted: 2026-02-20
• Last updated: 2026-02-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study