An Investigational Study to Evaluate the Effect of Rifampin on the Singe Dose of Experimental Medication BMS-986224 in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to investigate if the blood levels of experimental medication BMS-986224 will be changed when given together with Rifampin, an antibiotic that affects specific enzymes involved with the breakdown of BMS-986224.

Official Title
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A Phase I, Open-Label Study to Evaluate the Effect of Rifampin on the Single Dose Pharmacokinetics, Safety and Tolerability of BMS-986224 in Healthy Subjects

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: Rifampin
* Drug: BMS-986224


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 participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations Body mass index (BMI)of 18.0to 30.0 kg/m2, inclusive, at screening Exclusion Criteria: Women of childbearing potential Any significant acute or chronic medical illness Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption or history of cholecystectomy Other protocol defined inclusion/exclusion criteria may 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rifampin + BMS-986224<br>Oral administration | Drug: Rifampin<br>* Specified dose on specified days<br>Drug: BMS-986224<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 observed plasma concentration (Cmax) of BMS-986224 |  | 5 days | 
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986224 |  | 5 days | 
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224 |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker plasma concentrations of BMS-986224 |  | 5 days | 
| Time of maximum observed plasma concentration (Tmax) of BMS-986224 |  | 5 days | 
| Terminal elimination half-life (T-HALF) of BMS-986224 |  | 5 days | 
| Metabolite of BMS-986224 Cmax |  | 5 days | 
| Metabolite of BMS-986224 AUC(0-T) |  | 5 days | 
| Metabolite of BMS-986224 AUC(INF) |  | 5 days | 
| Incidence of nonserious adverse events (AE) |  | 17 days | 
| Incidence of serious adverse events (SAE) |  | 30 days | 
| Incidence of AEs leading to discontinuation |  | 17 days | 
| Composite results of vital signs, electrocardiograms, physical examinations,and clinical laboratory tests |  | 18 days |