A Study to Evaluate the Drug Levels, Physical and Chemical Changes, and Removal of BMS-986196 in Healthy Male Participants

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Single-center, Open-label Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of Orally Administered 60 mg BMS-986196, Including Radioactively Labeled [14C]-BMS-986196, in Healthy Male Participants

Conditions
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Healthy Male Volunteers

Intervention / Treatment
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* Drug: [14C]-BMS-986196


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [14C]-BMS-986196<br> | Drug: [14C]-BMS-986196<br>* Specified dose on specified days<br>* Other names: BMS-986196;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax |  | 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 | 
| Number of Participants with Clinical Laboratory Abnormalities |  | Up to Day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, BMS-986196, Healthy male volunteers, [14C]-BMS-986196, Total radioactivity