Phase 1, 2-Cohort, Open-label, Fixed-sequence, Drug-drug Interaction Study to Evaluate the Effect of Repotrectinib on the Pharmacokinetics of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants
| Registry | NCT07223671 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; non randomized, parallel, masking: none, treatment |
| Enrollment | 30 (Actual) |
| Sponsor | Bristol-Myers Squibb (Industry) |
| Conditions | Healthy Volunteers |
| Interventions | Repotrectinib, Metformin, Digoxin, Rosuvastatin, Bupropion, Flurbiprofen, Omeprazole (Drug) |
| Dates | start 2025-12-31, primary completion 2026-02-19, completion 2026-03-19, first posted 2025-11-03, last updated 2026-03-27 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Healthy Volunteers All trials of Repotrectinib All trials of Metformin
The purpose of the study if to evaluate the effect of Repotrectinib on the drug levels of transporter and CYP P450 probe substrates in healthy adult participants.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Cohort 1 | Experimental | Drug: Repotrectinib; Drug: Metformin; Drug: Digoxin; Drug: Rosuvastatin | |
| Cohort 2 | Experimental | Drug: Repotrectinib; Drug: Bupropion; Drug: Flurbiprofen; Drug: Omeprazole |
Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers
Inclusion Criteria * Participants must have a body mass index (BMI) of 18.0 to 32.0 kg/m2 and should be between the ages of 18-60 years inclusive. * Healthy female (as assigned at birth) participants who are individuals not of childbearing potential (INOCBP) and healthy males with no clinically significant deviation from normal for the following: medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessment results as determined by the investigator. Exclusion Criteria * Participants must not have a significant history of clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, psychiatric, neoplastic, or genitourinary abnormalities/diseases as determined by the investigator or designee. * Other protocol-defined Inclusion/Exclusion criteria apply.
| Facility | City | Country | Status |
|---|---|---|---|
| Local Institution - 0001 | Daytona Beach, Florida | United States |