A Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]BMS-986419 in Healthy Male Participants
Completed · Phase 1
Conditions studied: Healthy Volunteers
In brief
The purpose of this study is to assess the pharmacokinetics (PK), metabolite profile, routes and extent of elimination, mass balance, as well as safety and tolerability of \[14C\]BMS-986419 in healthy male participants.
Key facts
- Study ID
- NCT05847439
- Run by
- Bristol-Myers Squibb
- People needed
- 8
- Starts
- 2023-05-05
- Expected to finish
- 2023-07-05
- Last updated by the study team
- 2023-10-02
Who can join
Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- Body mass index between 18.0 and 33.0 kilograms/meter square (kg/m\^2), inclusive, at screening. Body mass index = weight (kg)/(height [m])2.
- Healthy male participants as determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [for example, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in (Day -2).
You may not qualify if…
- Any significant acute or chronic medical conditions.
- Any major surgery within 30 days of study intervention administration, such as gastrointestinal surgery (for example, cholecystectomy and any other gastrointestinal surgery) that could impact the absorption of study intervention (uncomplicated appendectomy and hernia repair are acceptable).
- Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could impact the absorption of study treatment.
- Note: Other protocol-defined inclusion/exclusion criteria apply.
Where it is running
- Labcorp Clinical Research Unit - Madison — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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