Study to Evaluate the Effect of Rifampin on the Drug Levels in Blood and Safety of BMS-986235 in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to examine the effect of rifampin on the drug levels in blood and safety of BMS-986235, when taken by healthy participants.

Official Title
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A Phase 1, Open-label Study to Evaluate the Effect of Rifampin on the Single Dose Pharmacokinetics, Safety, and Tolerability of BMS-986235 in Healthy Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986235 (Treatment A)
* Drug: Rifampin (Treatment B)


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 physical examination, ECGs, and clinical laboratory determinations; no significant findings in medical history. Body mass index of 18.0 kg/m2 to 30.0 kg/m2, inclusive, at screening Males must agree to follow specific methods of contraception, if applicable Exclusion Criteria: Women of childbearing potential (WOCBP) Known previous exposure to BMS-986235 History of any significant drug allergy 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br> | Drug: BMS-986235 (Treatment A)<br>* Specified dose on specified days<br>Drug: Rifampin (Treatment B)<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 plasma concentration (Cmax) of BMS-986235 |  | Day 1 | 
| Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 |  | Day 1 | 
| Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 |  | Day 1 | 
| Cmax of BMS-986235 with rifampin |  | Day 10 | 
| AUC(0-T) of BMS-986235 with rifampin |  | Day 10 | 
| AUC(INF) of BMS-986235 with rifampin |  | Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Nonserious Adverse Events (AEs) |  | Up to 46 days | 
| Incidence of Serious Adverse Events (SAEs) |  | Up to 74 days | 
| Incidence of AEs leading to discontinuation |  | Up to 13 days | 
| Incidence of clinically significant changes from baseline in physical examination findings |  | Up to 41 days | 
| Incidence of clinically significant changes in vital signs: Body temperature |  | Up to 41 days | 
| Incidence of clinically significant changes in vital signs: Respiratory rate |  | Up to 41 days | 
| Incidence of clinically significant changes in vital signs: Blood pressure |  | Up to 41 days | 
| Incidence of clinically significant changes in vital signs: Heart rate |  | Up to 41 days | 
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters |  | Up to 41 days | 
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests |  | Up to 41 days | 
| Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests |  | Up to 41 days | 
| Incidence of clinically significant changes in vital signs: Oxygen saturation (the amount of oxygen in blood (SpO2)) |  | Up to 41 days |