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

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: BMS-986278; Drug: Itraconazole; Drug: Gemfibrozil; Drug: Carbamazepine

• Registration Number: NCT05932303
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-06-27
• Study First Posted: 2023-07-06
• Study Start: 2023-07-12
• Status Verified: 2023-10
• Primary Completion: 2023-10-23
• Study Completion: 2023-10-23
• Last Update Submitted: 2023-10-26
• Last Update Posted: 2023-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
BMS-986278, followed by itraconazole	Itraconazole	-
BMS-986278, followed by gemfibrozil	BMS-986278	-
BMS-986278, followed by gemfibrozil	Gemfibrozil	-
BMS-986278, followed by carbamazepine	Carbamazepine	-
BMS-986278, followed by itraconazole	BMS-986278	-
BMS-986278, followed by carbamazepine	BMS-986278	-

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax)	Up to 33 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])	Up to 33 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])	Up to 33 days

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events (AEs)	Up to 33 days
Number of participants with electrocardiogram (ECG) abnormalities	Up to 33 days
Number of participants with physical examination abnormalities	Up to 33 days
Number of participants with vital sign abnormalities	Up to 33 days
Number of participants with clinical laboratory abnormalities	Up to 33 days

Trial Locations

Locations (1)

Local Institution - 0001; 🇨🇦 Québec, CA, Canada