Healthy Participants Clinical Trial
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
| Verified date | October 2023 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 47 |
| Est. completion date | October 23, 2023 |
| Est. primary completion date | October 23, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Local Institution - 0001 | Québec | CA |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum observed plasma concentration (Cmax) | Up to 33 days | ||
| Primary | Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T]) | Up to 33 days | ||
| Primary | Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) | Up to 33 days | ||
| Secondary | Number of participants with adverse events (AEs) | Up to 33 days | ||
| Secondary | Number of participants with physical examination abnormalities | Up to 33 days | ||
| Secondary | Number of participants with vital sign abnormalities | Up to 33 days | ||
| Secondary | Number of participants with electrocardiogram (ECG) abnormalities | Up to 33 days | ||
| Secondary | Number of participants with clinical laboratory abnormalities | Up to 33 days |
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