A Study to Assess the Levels in Blood Plasma of BMS-986278 in Healthy Participants Following Administration of Tablets, With or Without Food, and in the Presence of an Antacid (Esomeprazole)

Study Overview
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Brief Summary
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The purpose of this study is to assess levels in blood plasma of BMS-986278 and the food effect in healthy participants.

Official Title
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An Open-Label Study to Assess Relative Bioavailability, Food Effect, and Esomeprazole Drug-Drug Interaction of BMS-986278 Tablets Following a Single Dose Administration in Healthy Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986278 Tablet
* Drug: Esomeprazole
* Drug: BMS-986278 suspension


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Women of childbearing potential (WOCBP) and Women who are pregnant or breastfeeding 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 Exposure to any investigational drug or placebo within 4 weeks of first study treatment administration. History of any significant drug and/or food allergies (such as anaphylaxis or hepatotoxicity) 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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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-986278 suspension, fasted<br> | Drug: BMS-986278 suspension<br>* Specified dose on specified days<br>|
| Experimental: Treatment B: BMS-986278 tablet, fasted<br> | Drug: BMS-986278 Tablet<br>* Specified dose on specified days<br>|
| Experimental: Treatment C: BMS-986278 tablet, fed<br> | Drug: BMS-986278 Tablet<br>* Specified dose on specified days<br>|
| Experimental: Treatment D: BMS-986278 tablet + esomeprazole capsule, fasted<br> | Drug: BMS-986278 Tablet<br>* Specified dose on specified days<br>Drug: Esomeprazole<br>* Specified dose on specified days<br>* Other names: NEXIUM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) of BMS-986278 |  | Up to 5 days | 
| Area under the concentration-time curve from time 0 (dosing) to the time of the last quantifiable concentration observed (AUC(0-T) of BMS-986278 |  | Up to 5 days | 
| Area under the concentration-time curve from time 0 (dosing) extrapolated to infinity AUC (INF) of BMS-986278 from the respective test treatments |  | Up to 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) |  | Up to 29 days | 
| Incidence of Serious Adverse (SAE's) |  | Up to 57 days | 
| Incidence of AEs leading to discontinuation |  | Up to 29 days | 
| Incidence of clinically significant changes in vital signs: Blood pressure |  | Up to 48 days | 
| Incidence of clinically significant changes in vital signs: Heart rate |  | Up to 48 days | 
| Incidence of clinically significant changes in vital signs: Respiratory rate |  | Up to 48 days | 
| Incidence of clinically significant changes in vital signs: Body temperature |  | Up to 48 days | 
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters |  | Up to 48 days | 
| Incidence of clinically significant changes in physical examination findings |  | Up to 48 days | 
| Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests |  | Up to 48 days | 
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests |  | Up to 48 days | 
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests |  | Up to 48 days |