A Phase 1, Single-center, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]BMS-986419 in Healthy Male Participants
Overview
- Phase
- Phase 1
- Intervention
- [14C]BMS-986419
- Conditions
- Healthy Volunteers
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Maximum observed plasma concentration (Cmax)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Body mass index between 18.0 and 33.0 kilograms/meter square (kg/m\^2), inclusive, at screening. Body mass index = weight (kg)/(height \[m\])
- •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).
Exclusion Criteria
- •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.
Arms & Interventions
[14C]BMS-986419
Intervention: [14C]BMS-986419
Outcomes
Primary Outcomes
Maximum observed plasma concentration (Cmax)
Time Frame: Up to Day 20
Time of maximum plasma observed concentration (Tmax)
Time Frame: Up to Day 20
Percent of total radioactivity recovered (%Total)
Time Frame: Up to Day 30
Percent of total radioactivity recovered in urine (%UR)
Time Frame: Up to Day 30
Percent of total radioactivity recovered in feces (%FR)
Time Frame: Up to Day 30
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Time Frame: Up to Day 20
Total radioactivity recovered in urine (UR)
Time Frame: Up to Day 30
Total radioactivity recovered in feces (FR)
Time Frame: Up to Day 30
Total radioactivity recovered in bile (BR)
Time Frame: Up to Day 30
Total radioactivity recovered (Rtotal)
Time Frame: Up to Day 30
Secondary Outcomes
- Number of Participants with Physical Examination Abnormalities(Up to Day 30)
- Number of Participants with Adverse Events (AEs)(Up to Day 60)
- Number of Participants with Serious AEs (SAEs)(Up to Day 60)
- Number of Participants with AEs leading to discontinuation(Up to Day 60)
- Number of Participants with Vital Sign Abnormalities(Up to Day 30)
- Number of Participants with Electrocardiogram (ECG) Abnormalities(Up to Day 30)
- Number of Participants with Clinical Laboratory Abnormalities(Up to Day 30)