Study to Characterize the Effects of Cytochrome p450 1A2 Inhibition on Systemic Exposure to BMS-986165

Study Overview
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Brief Summary
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To compare the pharmacokinetic characteristics of BMS-986165 after a single-dose administration alone vs. in combination with fluvoxamine (CYP1A2 inhibitor)

Official Title
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An Open-label, Single-sequence Study to Investigate the Effects of Cytochrome P450 1A2 Inhibition on the Pharmacokinetics of BMS-986165 in Healthy Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: BMS-986165
* Drug: Fluvoxamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations in the opinion of the investigator. Body mass index of 18 to 32 kilograms per square meter (kg/m2), inclusive, and body weight ≥ 50 kg, at screening. Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) > 80 milliliter/minute/1.732 meter square calculated with the Chronic Kidney Disease Epidemiology Collaboration formula. Exclusion Criteria: Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, Any major surgery within 4 weeks of study drug administration Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986165+Fluvoxamine<br> | Drug: BMS-986165<br>* Participants will receive BMS-986165.<br>Drug: Fluvoxamine<br>* Participants will receive fluvoxamine.<br>|
| Experimental: BMS-986165 only<br> | Drug: BMS-986165<br>* Participants will receive BMS-986165.<br>|
| Experimental: Fluvoxamine only<br> | Drug: Fluvoxamine<br>* Participants will receive fluvoxamine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) of BMS-986165 |  | 10 days | 
| AUC(0-T) of BMS-986165 |  | 10 days | 
| AUC(INF) of BMS-986165 |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluvoxamine steady-state plasma concentrations |  | 10 days | 
| Percentage of participants with Adverse events (AEs) |  | From screening up to end of drug treatment (Day 13) | 
| Percentage of participants with Serious Adverse events (SAEs) and Death |  | From screening up to end of drug treatment (Day 13) | 
| Percentage of participants with Adverse events (AEs) leading to discontinutation |  | From screening up to end of drug treatment (Day 13) | 
| Percentage of participants with clinical significant laboratory abnormalities vital sign measurements and ECGs |  | From screening up to end of drug treatment (Day 13) |