Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986278 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-986278 as well as the safety and tolerability of BMS-986278 in healthy male participants.

Official Title
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Pharmacokinetics and Metabolism of [14C] BMS-986278 in Healthy Male Participants

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: [14C] BMS-986278
* Drug: Kinevac®


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: No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), vital signs, and clinical laboratory determinations Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, and total body weight ≥50 kg (110 lb), at screening. BMI = weight (kg)/(height [m])2 Males must agree to follow specific methods of contraception, if applicable 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, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could impact upon the absorption of study treatment Any major surgery within 6 weeks of study treatment administration Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br> | Drug: [14C] BMS-986278<br>* Specified dose on specified days<br>|
| Experimental: Group 2<br> | Drug: [14C] BMS-986278<br>* Specified dose on specified days<br>Drug: Kinevac®<br>* Specified dose on specified days<br>* Other names: Sincalide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) of BMS-986278 |  | Up to 15 days | 
| Maximum observed plasma concentration (Cmax) of total radioactivity (TRA) |  | Up to 15 days | 
| Time of maximum observed plasma concentration (Tmax) of BMS-986278 |  | Up to 15 days | 
| Time of maximum observed plasma concentration (Tmax) of TRA |  | Up to 15 days | 
| Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) of BMS-986278 |  | Up to 15 days | 
| Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) of TRA |  | Up to 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) |  | Up to 15 days | 
| Incidence of Serious Adverse Events (AEs) |  | Up to 73 days | 
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests |  | Up to 43 days | 
| Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests |  | Up to 43 days | 
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests |  | Up to 43 days | 
| Incidence of clinically significant changes in vital signs: Blood pressure |  | Up to 43 days | 
| Incidence of clinically significant changes in vital signs: Heart rate |  | Up to 43 days | 
| Incidence of clinically significant changes in vital signs: Respiratory rate |  | Up to 43 days | 
| Incidence of clinically significant changes in vital signs: Body temperature |  | Up to 43 days | 
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF | QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave. | Up to 43 days | 
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval | The QT interval is the time from the start of the Q wave to the end of the T wave. | Up to 43 days | 
| Incidence of clinically significant changes in physical examination findings |  | Up to 43 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteers