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

Bristol-Myers Squibb (BMS)

Status and phase: Withdrawn; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Itraconazole; Drug: BMS-986235; Drug: Fluconazole; Drug: Bupropion

Study type: Interventional

Funder types: Industry

Identifiers

NCT04464577

CV018-014

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Arm A: BMS-986235+Fluconazole

Experimental group

Treatment:

Drug: Fluconazole

Drug: BMS-986235

Arm B: BMS-986235+ Bupropion

Experimental group

Treatment:

Drug: BMS-986235

Drug: Bupropion

Arm C: BMS-986235+ Itraconazole

Experimental group

Treatment:

Drug: Itraconazole

Drug: BMS-986235