A Study to Assess the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on BMS-986278 in Healthy Participants

Study Overview
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Brief Summary
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This is a study in healthy participants designed to assess the effect of multiple doses of itraconazole, gemfibrozil, or carbamazepine on the drug levels of a single-dose of BMS-986278.

Official Title
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A Phase 1, 3-arm, Open-label, Sequential Design Study to Investigate the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on Single-dose Pharmacokinetics of BMS-986278 in Healthy Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986278
* Drug: Itraconazole
* Drug: Gemfibrozil
* Drug: Carbamazepine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) of 18.0 kilograms per meter squared (kg/m^2) through 32.0 kg/m^2, inclusive. BMI = weight (kg)/(height [m])2. Body weight ≥ 50 kg for males and ≥ 45 kg for females. Exclusion Criteria: Any significant acute or chronic medical illness. Any gastrointestinal disease or surgery (including cholecystectomy) or other procedures (for example, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion. Note: Appendectomy is allowed. Any major surgery within 4 weeks of study intervention administration. Other protocol-defined inclusion/exclusion criteria apply.

Ages Eligible for Study
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986278, followed by itraconazole<br> | Drug: BMS-986278<br>* Specified dose on specified days<br>Drug: Itraconazole<br>* Specified dose on specified days<br>|
| Experimental: BMS-986278, followed by gemfibrozil<br> | Drug: BMS-986278<br>* Specified dose on specified days<br>Drug: Gemfibrozil<br>* Specified dose on specified days<br>|
| Experimental: BMS-986278, followed by carbamazepine<br> | Drug: BMS-986278<br>* Specified dose on specified days<br>Drug: Carbamazepine<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) |  | Up to 33 days | 
| Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T]) |  | Up to 33 days | 
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) |  | Up to 33 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs) |  | Up to 33 days | 
| Number of participants with physical examination abnormalities |  | Up to 33 days | 
| Number of participants with vital sign abnormalities |  | Up to 33 days | 
| Number of participants with electrocardiogram (ECG) abnormalities |  | Up to 33 days | 
| Number of participants with clinical laboratory abnormalities |  | Up to 33 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMS-986278, Itraconazole, Gemfibrozil, Carbamazepine, Idiopathic pulmonary fibrosis, Drug interaction