A Study to Assess the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on BMS-986278 in Healthy Participants

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Gemfibrozil; Drug: Itraconazole; Drug: Carbamazepine; Drug: BMS-986278

Study type: Interventional

Funder types: Industry

Identifiers

NCT05932303

IM027-1007

Details and patient eligibility

About

This is a study in healthy participants designed to assess the effect of multiple doses of itraconazole, gemfibrozil, or carbamazepine on the drug levels of a single-dose of BMS-986278.

Enrollment: 47 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) of 18.0 kilograms per meter squared (kg/m^2) through 32.0 kg/m^2, inclusive.

BMI = weight (kg)/(height [m])2.

• Body weight ≥ 50 kg for males and ≥ 45 kg for females.

Exclusion criteria

• Any significant acute or chronic medical illness.
• Any gastrointestinal disease or surgery (including cholecystectomy) or other procedures (for example, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion. Note: Appendectomy is allowed.
• Any major surgery within 4 weeks of study intervention administration.

Other protocol-defined inclusion/exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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47 participants in 3 patient groups

BMS-986278, followed by itraconazole

Experimental group

Treatment:

Drug: BMS-986278

Drug: Itraconazole

BMS-986278, followed by gemfibrozil

Experimental group

Treatment:

Drug: BMS-986278

Drug: Gemfibrozil

BMS-986278, followed by carbamazepine

Experimental group

Treatment:

Drug: BMS-986278

Drug: Carbamazepine