A Study of Experimental Medication BMS-986278 Given to Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to investigate experimental medication BMS-986278 given to healthy participants.

Official Title
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A Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study (Including Food Effect, pH Effect, and Japanese Bridging Study) of the Safety, Pharmacokinetics, and Exploratory Pharmacodynamics of Oral BMS-986278 Administration in Healthy Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986278
* Other: Placebo


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: Participants must be in good general health in the opinion of the investigator Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening; BMI = weight (kg)/height (m)2 Body weight between 55 and 105 kg, inclusive, at screening Female participants must have documented proof that they are not of childbearing potential Participants in the Japanese cohorts must be first-generation Japanese (born in Japan, not living outside of Japan for more than 10 years, and both parents are ethnically Japanese) Exclusion Criteria: Women who are of childbearing potential 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, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome History or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug Any major surgery within 6 weeks of study drug administration Other protocol defined inclusion/exclusion criteria could 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Ascending Dose<br>BMS-986278 or placebo | Drug: BMS-986278<br>* Specified dose on specified days<br>Other: Placebo<br>* Specified dose on specified days<br>|
| Experimental: Multiple Ascending Dose<br>BMS-986278 or placebo | Drug: BMS-986278<br>* Specified dose on specified days<br>Other: Placebo<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 |
| --- | --- | --- |
| Number of participants experiencing adverse events (AE), serious adverse events (SAE), death, or an AE leading to study discontinuation |  | Up to 30 days | 
| Number of participants with potentially clinically significant changes in ECG parameters, vital signs, clinical laboratory parameters, or physical examinations |  | Up to 30 days |