A Study to Evaluate the Effect of Food on the Drug Levels of BMS-986196 in Healthy Adult Participants

Study Overview
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Brief Summary
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The purpose of this study is to assess the drug levels of BMS-986196 and to evaluate the effect of food (fasted versus fed [high-fat meal]) on the drug levels after administration of BMS-986196 tablet formulation at two dose levels in healthy adult participants.

Official Title
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A Phase 1, 2-part, Open-label, Randomized, 2-period, 2-sequence, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of BMS-986196 Phase 2 Tablet Formulation at Two Dose Levels in Healthy Adult Participants

Conditions
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Healthy Adult Volunteers

Intervention / Treatment
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* Drug: BMS-986196


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male participants and female participants without clinically significant deviation from normal, as determined by the investigator, in medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments. Body mass index of 18.0 to 35.0 kilograms/meter square (kg/m^2), inclusive, and body weight ≥ 50 kg. Participant must agree and be willing to consume a standard high-fat meal (for example, which may contain gluten). Exclusion Criteria: Any significant acute or chronic medical illness in the assessment of the investigator. Current or recent (within 3 months of study intervention) gastrointestinal (GI) disease that could possibly affect drug absorption, distribution, metabolism, and excretion (e.g., bariatric procedure) Any major surgery, including GI surgery (for example, cholecystectomy and any other GI surgery) that could impact upon the absorption of study intervention (uncomplicated appendectomy and hernia repair are acceptable). Note: 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: BMS-986196 Dose 1 (Treatment A)<br> | Drug: BMS-986196<br>* Specified dose on specified days<br>|
| Experimental: Part 1: BMS-986196 Dose 1 (Treatment B)<br> | Drug: BMS-986196<br>* Specified dose on specified days<br>|
| Experimental: Part 2: BMS-986196 Dose 2 (Treatment A)<br> | Drug: BMS-986196<br>* Specified dose on specified days<br>|
| Experimental: Part 2: BMS-986196 Dose 2 (Treatment B)<br> | Drug: BMS-986196<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 |
| --- | --- | --- |
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]) |  | Predose and post-dose up to Day 10 | 
| Maximum observed serum concentration (Cmax) |  | Predose and post-dose up to Day 10 | 
| Time of Cmax (Tmax) |  | Predose and post-dose up to Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs) |  | Up to Day 36 | 
| Number of participants with serious AEs (SAEs) |  | Up to Day 36 | 
| Number of participants with vital sign abnormalities |  | Up to Day 11 | 
| Number of participants with electrocardiogram (ECG) abnormalities |  | Up to Day 11 | 
| Change from baseline in columbia-suicide severity rating scale (C-SSRS) at day 11 |  | Baseline, Day 11 | 
| Number of participants with physical examination findings |  | Up to Day 11 | 
| Number of participants with clinical laboratory abnormalities |  | Up to Day 11 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMS-986196, Healthy adult participants, Pharmacokinetics, Cross-over study