A Study to Assess the Effect of BMS-986419 on the Single Dose Drug Levels of Probe Substrates in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to assess the effect of BMS-986419 on the pharmacokinetics (PK) of single doses of caffeine (CYP1A2 substrate), bupropion (CYP2B6 substrate), midazolam (CYP3A4 substrate), flurbiprofen (CYP2C9 substrate), omeprazole (CYP2C19 substrate), and fexofenadine (P-gp substrate), in healthy participants.

Official Title
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A Phase 1 Open-label Study to Assess the Effect of BMS-986419 on the Single Dose Pharmacokinetics of Probe Substrates (Caffeine, Bupropion, Flurbiprofen, Omeprazole, Midazolam, and Fexofenadine) in Healthy Participants

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: BMS-986419
* Drug: Caffeine
* Drug: Bupropion
* Drug: Flurbiprofen
* Drug: Omeprazole
* Drug: Midazolam
* Drug: Fexofenadine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female participants without clinically significant deviation from normal in medical history, physical examination (PE), electrocardiogram (ECG), and clinical laboratory determinations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in (Day -1). Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive, and total body weight ≥ 50 kg. BMI may be rounded. Exclusion Criteria: Any significant acute or chronic medical conditions or any significant acute or chronic medical illness as determined by the investigator Any major surgery within 30 days of study intervention administration, such as gastrointestinal surgery that could impact the absorption of study intervention 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cocktail Probe Substrates + BMS-986419<br> | Drug: BMS-986419<br>* Specified dose on specified days<br>Drug: Caffeine<br>* Specified dose on specified days<br>Drug: Bupropion<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: Fexofenadine<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 Day 25 | 
| Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) |  | Up to Day 25 | 
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) |  | Up to Day 25 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) |  | Up to Day 25 | 
| Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) |  | Up to Day 25 | 
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) |  | Up to Day 25 | 
| Number of participants with Adverse Events (AEs) |  | Up to 28 days after last dose | 
| Number of participants with Serious Adverse Events (SAEs) |  | Up to 28 days after last dose | 
| Number of participants with AEs leading to discontinuation |  | Up to 28 days after last dose | 
| Number of participants with vital sign abnormalities |  | Up to Day 25 | 
| Number of participants with 12-lead ECG assessment abnormalities |  | Up to Day 25 | 
| Number of participants with physical examination abnormalities |  | Up to Day 25 | 
| Columbia-Suicide Severity Rating Scale (C-SSRS) |  | Up to Day 25 | 
| Number of participants with clinical laboratory abnormalities |  | Up to Day 25 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy, pharmacokinetics, BMS-986419