A Study to Evaluate the Drug Levels of BMS-986166 in Healthy Male Participants

Study Overview
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Brief Summary
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The purpose of this study is to assess the drug levels of BMS-986166 in healthy male participants.

Official Title
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A Phase 1, Single-center, Open-label Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of [14C] BMS-986166 in Healthy Male Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986166
* Drug: Bisacodyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations Body mass index between 18.0 to 33.0 kg/m2 (inclusive) Exclusion Criteria: Any significant acute or chronic medical illness Current or recent history of constipation or irregular bowel movement (less than 1 bowel movement per day within the last 1 week) History of allergy (such as rash, hives, breathing difficulties) to any medications, either prescription or nonprescription 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group 1: BMS-986166<br> | Drug: BMS-986166<br>* Specified dose on specified days<br>Drug: Bisacodyl<br>* Specified dose on specified days<br>* Other names: Dulcolax®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total amount of total radioactivity (TRA) recovered in urine (UR) |  | Up to 90 days | 
| Total amount of TRA recovered in feces (FR) |  | Up to 90 days | 
| Total amount of TRA recovered in urine and feces combined (RTotal) |  | Up to 90 days | 
| Percent of TRA recovered in urine (%UR) |  | Up to 90 days | 
| Percent of TRA recovered in feces (%FR) |  | Up to 90 days | 
| Percent of TRA recovered in urine and feces combined (%TOTAL) |  | Up to 90 days | 
| Maximum observed concentration (Cmax) |  | Up to 89 days | 
| Time of maximum observed concentration (Tmax) |  | Up to 89 days | 
| Area under the concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)] |  | Up to 89 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs) |  | Up to 124 days | 
| Number of participants with serious adverse events (SAEs) |  | Up to 124 days | 
| Number of participants with vital sign abnormalities |  | Up to 90 days | 
| Number of participants with electrocardiogram (ECG) abnormalities |  | Up to 90 days | 
| Number of participants with physical examination abnormalities |  | Up to 90 days | 
| Number of participants with clinical laboratory test abnormalities |  | Up to 90 days | 
| Maximum observed concentration (Cmax) |  | Up to 89 days | 
| Time of maximum observed concentration (Tmax) |  | Up to 89 days | 
| Area under the concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)] |  | Up to 89 days |