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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05932303
Enrollment
47
Registered
2023-07-06
Start date
2023-07-12
Completion date
2023-10-23
Last updated
2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Keywords

BMS-986278, Itraconazole, Gemfibrozil, Carbamazepine, Idiopathic pulmonary fibrosis, Drug interaction

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.

Interventions

DRUGBMS-986278

Specified dose on specified days

DRUGItraconazole

Specified dose on specified days

DRUGGemfibrozil

Specified dose on specified days

DRUGCarbamazepine

Specified dose on specified days

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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/

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Number of participants with electrocardiogram (ECG) abnormalitiesUp to 33 days
Number of participants with adverse events (AEs)Up to 33 days
Number of participants with clinical laboratory abnormalitiesUp to 33 days
Number of participants with physical examination abnormalitiesUp to 33 days
Number of participants with vital sign abnormalitiesUp to 33 days

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026