Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986256 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 way the body absorbs, distributes, breaks down and eliminates radioactive BMS-986856 in healthy males.

Detailed Description
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Recruitment temporarily on hold due to COVID-19.

Official Title
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Pharmacokinetics and Metabolism of a Single Dose of [14C] BMS-986256 in Healthy Male Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986256
* Drug: Milk of magnesia


Participation Criteria
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Eligibility Criteria
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Healthy participants, as determined by no clinically significant deviations from normal in medical history, physical examination abnormalities that would compromise the ability to participate, complete, and/or interpret the results of the study, 12-lead electrocardiograms (ECGs), vital signs, and clinical laboratory results. Males must agree to follow specific methods of contraception, if applicable, while participating in the trial Exclusion Criteria: Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study History of any significant drug and/or food allergies 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: BMS-986256<br> | Drug: BMS-986256<br>* Specified dose on specified days<br>Drug: Milk of magnesia<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) of [14C] BMS-986256 |  | Up to 49 days | 
| Time to attain maximum observed plasma concentration (Tmax) of [14C] BMS-986256 |  | Up to 49 days | 
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC (0-T)) of [14C] BMS-986256 |  | Up to 49 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) |  | Up to 49 days | 
| Incidence of Serious Adverse Events (SAEs) |  | Up to 49 days | 
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests |  | Up to 49 days | 
| Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests |  | Up to 49 days | 
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests |  | Up to 49 days | 
| Incidence of clinically significant changes in vital signs: Blood pressure |  | Up to 49 days | 
| Incidence of clinically significant changes in vital signs: Heart rate |  | Up to 49 days | 
| Incidence of clinically significant changes in vital signs: Respiratory rate |  | Up to 49 days | 
| Incidence of clinically significant changes in vital signs: Body temperature |  | Up to 49 days | 
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters |  | Up to 49 days | 
| Incidence of clinically significant changes in physical examination findings |  | Up to 49 days |