NCT05932303CompletedPhase 1
A Phase 1, 3-arm, Open-label, Sequential Design Study to Investigate the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on Single-dose Pharmacokinetics of BMS-986278 in Healthy Participants
Bristol-Myers Squibb1 site in 1 country47 target enrollmentStarted: July 12, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Maximum observed plasma concentration (Cmax)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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])
- •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.
Arms & Interventions
BMS-986278, followed by itraconazole
Experimental
Intervention: BMS-986278 (Drug)
BMS-986278, followed by itraconazole
Experimental
Intervention: Itraconazole (Drug)
BMS-986278, followed by gemfibrozil
Experimental
Intervention: BMS-986278 (Drug)
BMS-986278, followed by gemfibrozil
Experimental
Intervention: Gemfibrozil (Drug)
BMS-986278, followed by carbamazepine
Experimental
Intervention: BMS-986278 (Drug)
BMS-986278, followed by carbamazepine
Experimental
Intervention: Carbamazepine (Drug)
Outcomes
Primary Outcomes
Maximum observed plasma concentration (Cmax)
Time Frame: Up to 33 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])
Time Frame: Up to 33 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Time Frame: Up to 33 days
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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