A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants

Study Overview
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Brief Summary
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This study is designed to assess the effect of BMS-986196 on the drug levels of caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin in healthy participants.

Official Title
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A Phase 1, Single-center, Open-label, Sequential Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: BMS-986196
* Drug: Caffeine
* Drug: Montelukast
* Drug: Flurbiprofen
* Drug: Omeprazole
* Drug: Midazolam
* Drug: Digoxin
* Drug: Pravastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations. Body mass index of 18.0 to 33.0 kilogram per meter squared (kg/m^2), inclusive, and body weight ≥50.0 kg. Exclusion Criteria: History of rhabdomyolysis. History of peptic ulcer disease or significant GI bleeding. History of malignancy in the 5 years prior to screening (except fully excised basal cell carcinoma).

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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986196 and/or Cocktail Probe Substrate Drugs<br> | Drug: BMS-986196<br>* Specified dose on specified days<br>Drug: Caffeine<br>* Specified dose on specified days<br>Drug: Montelukast<br>* Specified dose on specified days<br>Drug: Flurbiprofen<br>* Specified dose on specified days<br>Drug: Omeprazole<br>* Specified dose on specified days<br>Drug: Midazolam<br>* Specified dose on specified days<br>Drug: Digoxin<br>* Specified dose on specified days<br>Drug: Pravastatin<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 26 days | 
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) |  | Up to 26 days | 
| Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T]) |  | Up to 26 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of maximum observed serum concentration (Tmax) |  | Up to 26 days | 
| Apparent terminal phase half-life (T-Half) |  | Up to 26 days | 
| Apparent total body clearance (CLT/F) |  | Up to 26 days | 
| Number of participants with adverse events (AEs) |  | Up to 52 days | 
| Number of participants with vital sign abnormalities |  | Up to 28 days | 
| Number of participants with electrocardiogram (ECG) abnormalities |  | Up to 21 days | 
| Number of participants with physical examination abnormalities |  | Up to 28 days | 
| Number of participants with clinical laboratory abnormalities |  | Up to 28 days | 
| Intensity of Suicidal Ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Score |  | Up to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMS-986196