A Study to Learn How the Medicine Called [14C] PF-06821497 is Taken up Into and Removed From the Body. - Trial NCT06392230
Access comprehensive clinical trial information for NCT06392230 through Pure Global AI's free database. This Phase 1 trial is sponsored by Pfizer and is currently Not yet recruiting. The study focuses on Healthy Participants. Target enrollment is 6 participants.
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Study Focus
Sponsor & Location
Pfizer
Timeline & Enrollment
Phase 1
May 24, 2024
Aug 09, 2024
Primary Outcome
Total recovery of radioactivity in urine, feces, and total excreta (urine + feces) as percentage of total radioactive dose administered,Metabolic profiling/identification and determination of relative abundance of [14C]PF-06821497 and the metabolites of [14C]PF-06821497 in plasma, urine, and feces
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06392230
Non-Device Trial