A Study to Understand What the Body Does to the Study Medicine Called PF-07799544 When Taken by Healthy Adults

Conditions

• Healthy Male Volunteers

Eligibility Criteria

Sex

MALE

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• Oral [14C] PF-07799544 — DRUG
  A single oral dose of \[14C\] PF-07799544 will be administered as an extemporaneous suspension in Period 1.
• Oral Unlabeled PF-07799544 — DRUG
  A single oral dose of unlabeled PF-07799544 will be administered as extemporaneous solution in Period 2.
• IV [14C] PF-07799544 — DRUG
  A single IV infusion of \[14C\] PF-07799544 will be administered at the approximate Tmax after administration of the unlabeled oral dose of PF-07248144 in Period 2.

Study Details

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-07799544 is taken up into the bloodstream and removed from the body. The study is seeking participants who are: Male Ages 18 to 55 years of age confirmed to be healthy based on medical and physical tests. Weigh more than 50 kilograms (kg) and have a body mass index of 17.5 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-07799544 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-07799544 by mouth and one small dose of \[14C\] PF-07799544 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-07799544 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 7 weeks, including evaluation at the start and follow-up period.

Key Dates

Start date

May 15, 2026

Status verified

Jun 2026

Primary completion

Jul 22, 2026

Completion

Sep 12, 2026

Study Design

Enrollment

9 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Cohort 1
  Participants will receive one dose of \[14C\] PF-07799544 by mouth in Period 1. After a washout, participants will receive one dose of PF-07799544 by mouth and one intravenous (IV) infusion of \[14C\] PF-07799544 in Period 2

Primary Outcome Measure

Total recovery (%) of radioactivity in urine, feces and vomitus (if any), expressed as a percent of total oral radioactive dose administered. [ Time Frame: Period 1 pre-dose to maximum days 15 ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (1)

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