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

StatusCompleted
PhasePhase 1
SponsorPfizer
Started

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Record History

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  1. Notable Primary endpoints: details revised at 1 of 2 entries Show 4 more changesShow less
    • Trial completed
    • Study completion date changed from estimate of Aug 17, 2026 to Aug 15, 2026
    • Eligibility criteria revised
    • Secondary endpoints: details revised at 7 of 7 entries
  2. Minor Enrollment closed, study ongoing
    • Study completion date: Aug 15, 2026 to Aug 17, 2026
    • Start date: May 15, 2026 to May 18, 2026
    • Site details revised
    v6
  3. Minor Start date changed from estimate of Jun 2026 to May 15, 2026v5
  4. Minor Start date: May 15, 2026 to Jun 2026v4
  5. Minor Primary completion date: Jul 22, 2026 to Jul 2, 2026
    • Study completion date: Sep 12, 2026 to Aug 15, 2026
    v3
  6. Notable Recruitment opened
    • Primary completion moved earlier from Sep 12, 2026 to Jul 22, 2026
    • Study sites: 0 to 1
    v2
  7. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
438 trials monitored
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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.
Trial Details
NCT Number NCT07578636
Lead Sponsor Pfizer
Conditions
(from sponsor)
Healthy Male Volunteers
Enrollment 9 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov