An Investigational Study of Experimental Medication BMS-986278 Given With the Antibiotic Rifampin in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effects of experimental medication BMS-986278 given with the antibiotic Rifampin in healthy participants.

Official Title
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A Drug-Drug Interaction Study to Assess the Effect of Rifampin on the Pharmacokinetics of an Oral Dose of BMS-986278 in Healthy Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986278
* Drug: Rifampin


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: Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening 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 History of significant cardiovascular disease Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could impact upon the absorption of study treatment 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986278 + Rifampin<br>Treatment period A: BMS-986278 alone Treatment period B: Rifampin followed by BMS-986278 | Drug: BMS-986278<br>* Oral administration 30 mg<br>Drug: Rifampin<br>* Oral administration 600 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) for BMS-986278 |  | Day 1 and 8 | 
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for BMS-986278 |  | Up to 24 days | 
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for BMS-986278 |  | Day 1 and 8 | 
| Terminal phase half-life (T-HALF) for BMS-986278 |  | Day 1 and 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of non-serious adverse events (AE) |  | Up to 24 days | 
| Incidence of serious adverse events (SAE) |  | Up to 24 days | 
| Incidence of AE leading to discontinuation |  | Up to 24 days | 
| Incidence of clinically significant changes in vital signs, electrocardiograms (ECGs), physical examinations, and clinical laboratory tests |  | Up to 24 days | 
| Maximum observed plasma concentration (Cmax) for Rifampin |  | Day 8 | 
| Time of maximum observed plasma concentration (Tmax) for Rifampin |  | Day 8 | 
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for Rifampin |  | Day 8-9 | 
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for Rifampin |  | Day 8-9 |