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

NCT05932303 — Phase 1, Completed, 47 participants, Bristol-Myers Squibb

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT05932303
Status	Completed
Phase	Phase 1
Study type	Interventional; non randomized, sequential, masking: none, treatment
Enrollment	47 (Actual)
Sponsor	Bristol-Myers Squibb (Industry)
Conditions	Healthy Participants
Interventions	BMS-986278, Itraconazole, Gemfibrozil, Carbamazepine (Drug)
Dates	start 2023-07-12, primary completion 2023-10-23, completion 2023-10-23, first posted 2023-07-06, last updated 2023-10-30
Locations	1 site in Canada

-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.

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+Arms and interventions

Arm	Type	Interventions
BMS-986278, followed by itraconazole	Experimental	Drug: BMS-986278; Drug: Itraconazole
BMS-986278, followed by gemfibrozil	Experimental	Drug: BMS-986278; Drug: Gemfibrozil
BMS-986278, followed by carbamazepine	Experimental	Drug: BMS-986278; Drug: Carbamazepine

BMS-986278 (Drug): Specified dose on specified days
Itraconazole (Drug): Specified dose on specified days
Gemfibrozil (Drug): Specified dose on specified days
Carbamazepine (Drug): Specified dose on specified days

+Outcome measures

Primary outcomes

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 outcomes

Number of participants with adverse events (AEs) [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 electrocardiogram (ECG) abnormalities [Up to 33 days]
Number of participants with clinical laboratory abnormalities [Up to 33 days]

+Eligibility

Sex: All, ages: 18 Years to 65 Years, 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.

+Locations (1)

Facility	City	Country	Status
Local Institution - 0001	Québec, CA	Canada

+Investigators

Bristol-Myers Squibb, Study director, Bristol-Myers Squibb