Pharmacokinetics (Drug Levels in Blood) of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to characterize the pharmacokinetics (the way the body absorbs, distributes and eliminates the drug) of BMS 986165 given in the form of various prototypes of solid tablets to healthy participants.

Official Title
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A Study to Evaluate the Pharmacokinetics of BMS-986165 Administered as Various Prototypic Solid Tablet Formulations in Healthy Subjects

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986165
* Drug: BMS-986165 prototype 1
* Drug: BMS-986165 prototype 2


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: In the opinion of the investigator, a healthy participant is determined by having no clinically significant deviation from normal in medical history, physical examination,electrocardiograms, vital signs, and clinical laboratory determinations. Body weight >= 50 kg at screening Women and men must agree to follow specific methods of contraception, if applicable Exclusion Criteria: Any major surgery, per investigator's discretion, within 4 weeks of study drug administration Inability to tolerate oral medication History of allergy to BMS-986165 or related compounds Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A : BMS-986165<br> | Drug: BMS-986165<br>* Specified dose on specified days<br>|
| Experimental: Treatment B: BMS-986165 prototype 1<br> | Drug: BMS-986165 prototype 1<br>* Specified dose on specified days<br>|
| Experimental: Treatment C: BMS-986165 prototype 2<br> | Drug: BMS-986165 prototype 2<br>* Specified dose on specified days<br>|
| Experimental: Treatment D: BMS-986165 prototype 2<br> | Drug: BMS-986165 prototype 2<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 concentration (Cmax) for BMS-986165 in plasma |  | Up to 18 days | 
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T)) for BMS-986165 in plasma |  | Up to 18 days | 
| Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) for BMS-986165 in plasma |  | Up to 18 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) |  | Up to 23 days | 
| Incidence of Serious Adverse Events (SAEs) |  | Up to 55 days | 
| Number of clinically significant abnormalities in electrocardiogram (ECG) parameters |  | Up to 50 days | 
| Number of participants with vital sign abnormalities in body temperature |  | Up to 50 days | 
| Number of participants with vital sign abnormalities in respiratory rate |  | Up to 50 days | 
| Number of participants with vital sign abnormalities in heart rate |  | Up to 50 days | 
| Number of participants with vital sign abnormalities in blood pressure |  | Up to 50 days | 
| Number of participants with clinical laboratory test abnormalities: Hematology tests |  | Up to 50 days | 
| Number of participants with clinical laboratory test abnormalities: Clinical chemistry tests |  | Up to 50 days | 
| Number of participants with clinical laboratory test abnormalities: Urinalysis tests |  | Up to 50 days |