Healthy Male Volunteers
Conditions
Keywords
Pharmacokinetics, BMS-986196, Healthy male volunteers, [14C]-BMS-986196, Total radioactivity
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.
Interventions
DRUG[14C]-BMS-986196
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Radioactivity (TRA): Maximum observed plasma concentration (Cmax) | Up to Day 15 |
| TRA: Time of Cmax (Tmax) | Up to Day 15 |
| 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: Amount of radioactivity recovered in urine (UR) | Up to Day 15 |
| TRA: Amount of radioactivity recovered in feces (FR) | Up to Day 15 |
| TRA: Amount of radioactivity recovered in bile (BR) | Up to 14 hours post dose |
| TRA: Percent of administered dose recovered in urine (%UR) | Up to Day 15 |
| TRA: Percent of administered dose recovered in feces (%FR) | Up to Day 15 |
| TRA: Total percent of administered dose recovered (urine, feces, and bile combined) (% Total) | Up to Day 15 |
Secondary
| Measure | Time frame |
|---|---|
| Cmax | Up to Day 15 |
| Number of Participants with Clinical Laboratory Abnormalities | Up to Day 15 |
| Tmax | Up to Day 15 |
| AUC (0-T) | 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 |
| Number of Participants with Vital Sign Abnormalities | Up to Day 15 |
| Number of Participants with Electrocardiogram (ECG) Abnormalities | Up to Day 15 |
| Number of Participants with Physical Examination Abnormalities | Up to Day 15 |
Countries
United States
Outcome results
None listed