A Study to Evaluate the Drug Levels, Physical and Chemical Changes, and Removal of BMS-986196 in Healthy Male Participants
Phase 1
Completed
- Conditions
- Healthy Male Volunteers
- Interventions
- Drug: [14C]-BMS-986196
- Registration Number
- NCT05981963
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate the excretion pathway of orally administered \[14C\]-BMS-986196 and to assess the safety and tolerability of orally administered BMS-986196.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 8
Inclusion Criteria
- Healthy male participants without clinically significant deviation from normal in medical history, electrocardiogram (ECG), clinical laboratory determinations, and Day -1 physical examination.
- Body mass index of 18.0 to 35.0 kilograms/meter square (kg/m^2), inclusive, and total body weight ≥ 50 kg
Exclusion Criteria
- Any significant acute or chronic medical illness as determined by the investigator.
- A history of clinically significant hepatic or pancreatic disease.
- Current or recent (within 3 months prior to study treatment administration) gastrointestinal disease that could impact upon the absorption, distribution, metabolism, or excretion of study treatment as determined by the investigator.
Note: Other protocol-defined inclusion/exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description [14C]-BMS-986196 [14C]-BMS-986196 -
- Primary Outcome Measures
Name Time Method TRA: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]) Up to Day 15 TRA: Total percent of administered dose recovered (urine, feces, and bile combined) (% Total) Up to Day 15 TRA: Time of Cmax (Tmax) Up to Day 15 TRA: Percent of administered dose recovered in feces (%FR) Up to Day 15 Total Radioactivity (TRA): Maximum observed plasma concentration (Cmax) Up to Day 15 TRA: Amount of radioactivity recovered in urine (UR) Up to Day 15 TRA: Amount of radioactivity recovered in feces (FR) Up to Day 15 TRA: Percent of administered dose recovered in urine (%UR) Up to Day 15 TRA: Amount of radioactivity recovered in bile (BR) Up to 14 hours post dose
- Secondary Outcome Measures
Name Time Method AUC (0-T) Up to Day 15 Number of Participants with Physical Examination Abnormalities Up to Day 15 Number of Participants with Clinical Laboratory Abnormalities Up to Day 15 Tmax Up to Day 15 Number of Participants with Adverse Events (AEs) Up to Day 29 Number of Participants with Serious AEs (SAEs) Up to Day 29 Number of Participants with AEs Leading to Discontinuation Up to Day 29 Cmax Up to Day 15 Number of Participants with Vital Sign Abnormalities Up to Day 15 Number of Participants with Electrocardiogram (ECG) Abnormalities Up to Day 15
Trial Locations
- Locations (1)
Labcorp Clinical Research Unit - Madison
🇺🇸Madison, Wisconsin, United States