A Study to Evaluate the Effect of Fluconazole, Bupropion, or Itraconazole on the Drug Levels and Safety of BMS-986235

Study Overview
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Brief Summary
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This study will evaluate the effect of inhibitors, at steady state, on the drug levels, safety, and tolerability of BMS-986235 when taken by healthy participants. The inhibitors to be utilized in this study are fluconazole, bupropion, and itraconazole.

Official Title
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A Phase 1, Open-label Study to Evaluate the Effect of Fluconazole, Bupropion, or Itraconazole on the Pharmacokinetics and Safety of BMS-986235

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: Fluconazole
* Drug: Bupropion
* Drug: Itraconazole
* Drug: BMS-986235


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening. Males and females must agree to follow specific methods of contraception, if applicable. Healthy participants, as determined by no clinically significant deviation from normal in physical examination, ECGs, and clinical laboratory determinations, and no significant findings in medical history. Exclusion Criteria: Women of childbearing potential (WOCBP), women who are pregnant or breastfeeding Inability to tolerate oral medication Known previous exposure to BMS-986235. 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: BMS-986235+Fluconazole<br> | Drug: Fluconazole<br>* Specified Dose on Specified Days<br>Drug: BMS-986235<br>* Specified Dose on Specified Days<br>|
| Experimental: Arm B: BMS-986235+ Bupropion<br> | Drug: Bupropion<br>* Specified Dose on Specified Days<br>Drug: BMS-986235<br>* Specified Dose on Specified Days<br>|
| Experimental: Arm C: BMS-986235+ Itraconazole<br> | Drug: Itraconazole<br>* Specified Dose on Specified Days<br>Drug: BMS-986235<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 plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with fluconazole |  | Day 12 | 
| Maximum plasma concentration (Cmax) of BMS-986235 with fluconazole |  | Day 12 | 
| Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with fluconazole |  | Day 12 | 
| Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with bupropion |  | Day 13 | 
| Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with bupropion |  | Day 13 | 
| Maximum plasma concentration (Cmax) of BMS-986235 with bupropion |  | Day 13 | 
| Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with itraconazole |  | Day 9 | 
| Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with itraconazole |  | Day 9 | 
| Maximum plasma concentration (Cmax) of BMS-986235 with itraconazole |  | Day 9 | 
| Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 |  | Day 1 | 
| Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 |  | Day 1 | 
| Maximum plasma concentration (Cmax) of BMS-986235 |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Nonserious Adverse Events (AEs) |  | Up to 49 days | 
| Incidence of Serious Adverse Events (SAEs) |  | Up to 77 days | 
| Incidence of AEs leading to discontinuation |  | Up to 16 days | 
| Number of clinically significant changes from baseline in vital signs: Body Temperature |  | Up to 44 days | 
| Number of clinically significant changes from baseline in physical examinations |  | Up to 44 days | 
| Number of clinically significant changes in clinical laboratory tests: Hematology |  | Up to 44 days | 
| Number of clinically significant changes in clinical laboratory tests: Clinical Chemistry |  | Up to 44 days | 
| Number of clinically significant changes in clinical laboratory tests: Coagulation |  | Up to 44 days | 
| Number of clinically significant changes in clinical laboratory tests: Urinalysis |  | Up to 44 days | 
| Number of clinically significant changes from baseline in vital signs: Respiratory Rate |  | Up to 44 days | 
| Number of clinically significant changes from baseline in vital signs: Heart Rate |  | Up to 44 days | 
| Number of clinically significant changes from baseline in vital signs:Blood Pressure |  | Up to 44 days | 
| Number of clinically significant changes in electrocardiogram (ECG) |  | Up to 44 days | 
| Number of clinically significant changes in vital signs: Oxygen saturation (the amount of oxygen in blood (SpO2)) |  | Up to 44 days |