A Study to Compare the Taste and Levels in Blood Plasma of BMS-986165 When Taken as Different Formulations by Healthy Adult Participants

Study Overview
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Brief Summary
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The purpose of this study is to compare the taste, and the levels in blood plasma of different tablet formulations of BMS-986165 when taken by healthy adults.

Official Title
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An Open-Label Cross-Over Study to Compare Bioavailability, Dose Proportionality, and Palatability of Single Doses of BMS-986165 Minitablet Pediatric Formulation in Fasted and Fed Conditions Relative to Single Doses of BMS-986165 Clinical Formulations In Healthy Adult Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986165 Tablet formulation 1
* Drug: BMS-986165 Tablet formulation 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: Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations in the opinion of the investigator Women and men 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 may compromise the objectives of the study, including a history of/or active liver disease 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: 55 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 Group 1<br> | Drug: BMS-986165 Tablet formulation 1<br>* Specified dose on specified days<br>Drug: BMS-986165 Tablet formulation 2<br>* Specified dose on specified days<br>|
| Experimental: Treatment Group 2<br> | Drug: BMS-986165 Tablet formulation 1<br>* Specified dose on specified days<br>Drug: BMS-986165 Tablet formulation 2<br>* Specified dose on specified days<br>|
| Experimental: Treatment Group 3<br> | Drug: BMS-986165 Tablet formulation 1<br>* Specified dose on specified days<br>Drug: BMS-986165 Tablet formulation 2<br>* Specified dose on specified days<br>|
| Experimental: Treatment Group 4<br> | Drug: BMS-986165 Tablet formulation 1<br>* Specified dose on specified days<br>Drug: BMS-986165 Tablet formulation 2<br>* Specified dose on specified days<br>|
| Experimental: Treatment Group 5<br> | Drug: BMS-986165 Tablet formulation 1<br>* Specified dose on specified days<br>Drug: BMS-986165 Tablet formulation 2<br>* Specified dose on specified days<br>|
| Experimental: Treatment Group 6<br> | Drug: BMS-986165 Tablet formulation 1<br>* Specified dose on specified days<br>Drug: BMS-986165 Tablet formulation 2<br>* Specified dose on specified days<br>|
| Experimental: Treatment Group 7<br> | Drug: BMS-986165 Tablet formulation 1<br>* Specified dose on specified days<br>Drug: BMS-986165 Tablet formulation 2<br>* Specified dose on specified days<br>|
| Experimental: Treatment Group 8<br> | Drug: BMS-986165 Tablet formulation 1<br>* Specified dose on specified days<br>Drug: BMS-986165 Tablet formulation 2<br>* Specified dose on specified days<br>|
| Experimental: Treatment Group 9<br> | Drug: BMS-986165 Tablet formulation 1<br>* Specified dose on specified days<br>Drug: BMS-986165 Tablet formulation 2<br>* Specified dose on specified days<br>|
| Experimental: Treatment Group 10<br> | Drug: BMS-986165 Tablet formulation 1<br>* Specified dose on specified days<br>Drug: BMS-986165 Tablet formulation 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) in plasma for BMS-986165 |  | Up to 26 days | 
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T)) in plasma for BMS-986165 |  | Up to 26 days | 
| Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) in plasma for BMS-986165 |  | Up to 26 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) |  | Up to 26 days | 
| Incidence of Serious Adverse Events (SAEs) |  | Up to 98 days | 
| Incidence of clinically significant changes in physical examination findings |  | Up to 68 days | 
| Incidence of clinically significant changes in vital signs: Weight |  | Up to 68 days | 
| Incidence of clinically significant changes in vital signs: Body temperature |  | Up to 68 days | 
| Incidence of clinically significant changes in vital signs: Respiratory rate |  | Up to 68 days | 
| Incidence of clinically significant changes in vital signs: Blood pressure |  | Up to 68 days | 
| Incidence of clinically significant changes in vital signs: Heart rate |  | Up to 68 days | 
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters |  | Up to 68 days | 
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests |  | Up to 68 days | 
| Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests |  | Up to 68 days | 
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests |  | Up to 68 days |