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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05932303
• Collaborator: (none)
• Enrollment: 48
• Arms: 3
• Anticipated Duration (Months): 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: BMS-986278; Drug: Itraconazole; Drug: Gemfibrozil; Drug: Carbamazepine	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 48 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Anticipated Study Start Date: Jul 10, 2023
• Anticipated Primary Completion Date: Oct 3, 2023
• Anticipated Study Completion Date: Oct 3, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMS-986278, followed by itraconazole	Drug: BMS-986278; Specified dose on specified days; Drug: Itraconazole; Specified dose on specified days
Experimental: BMS-986278, followed by gemfibrozil	Drug: BMS-986278; Specified dose on specified days; Drug: Gemfibrozil; Specified dose on specified days
Experimental: BMS-986278, followed by carbamazepine	Drug: BMS-986278; Specified dose on specified days; Drug: Carbamazepine; Specified dose on specified days

Outcome Measures

Primary Outcome Measures

1. Maximum observed plasma concentration (Cmax) [Up to 33 days]

2. Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T]) [Up to 33 days]

3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) [Up to 33 days]

Secondary Outcome Measures

1. Number of participants with adverse events (AEs) [Up to 33 days]

2. Number of participants with physical examination abnormalities [Up to 33 days]

3. Number of participants with vital sign abnormalities [Up to 33 days]

4. Number of participants with electrocardiogram (ECG) abnormalities [Up to 33 days]

5. Number of participants with clinical laboratory abnormalities [Up to 33 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: 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])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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT05932303
• Other Study ID Numbers: IM027-1007
• First Posted: Jul 6, 2023
• Last Update Posted: Jul 6, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bristol-Myers Squibb: BMS-986278; Itraconazole; Gemfibrozil; Carbamazepine; Idiopathic pulmonary fibrosis; Drug interaction
• Additional relevant MeSH terms: Itraconazole; Carbamazepine; Gemfibrozil

Study Results

No Results Posted as of Jul 6, 2023