Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants

Not Applicable

Not yet recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: Repotrectinib; Drug: Metformin; Drug: Bupropion; Drug: Digoxin; Drug: Flurbiprofen; Drug: Rosuvastatin; Drug: Omeprazole

• Registration Number: NCT07223671
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-30
• Study First Submitted QC: 2025-10-30
• Last Update Submitted: 2025-10-30
• Study First Posted: 2025-11-03
• Last Update Posted: 2025-11-03
• Study Start: 2025-11-12
• Primary Completion: 2026-02-19
• Study Completion: 2026-03-19

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	Repotrectinib	-
Cohort 1	Metformin	-
Cohort 1	Digoxin	-
Cohort 1	Rosuvastatin	-
Cohort 2	Repotrectinib	-
Cohort 2	Bupropion	-
Cohort 2	Flurbiprofen	-
Cohort 2	Omeprazole	-

Primary Outcome Measures

Name	Time	Method
Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration of AUC (0-T) of Probe Substrate With Repotrectinib	Up to approximately Day 17 post dose	Probe substrate contains metformin, digoxin, and rosuvastatin.
Cohort 1: AUC (0-T) of Probe Substrate Without Repotrectinib	Up to approximately Day 17 post dose	Probe substrate contains metformin, digoxin, and rosuvastatin.
Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of Probe Substrate With Repotrectinib	Up to approximately Day 17 post dose	Probe substrate contains metformin, digoxin, and rosuvastatin.
Cohort 1: AUC(INF) of Probe Substrate Without Repotrectinib	Up to approximately Day 17 post dose	Probe substrate contains metformin, digoxin, and rosuvastatin.
Cohort 1: Maximum Observed Plasma Concentration (Cmax) of Probe Substrate With Repotrectinib	Up to approximately Day 17 post dose	Probe substrate contains metformin, digoxin, and rosuvastatin
Cohort 1: Cmax of Probe Substrate Without Repotrectinib	Up to approximately Day 17 post dose	Probe substrate contains metformin, digoxin, and rosuvastatin
Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero to 48 Hours Post Dose (AUC (0-48)) of Metformin With Repotrectinib	Up to approximately Day 17 post dose
Cohort 1: AUC (0-48) of Metformin Without Repotrectinib	Up to approximately Day 17 post dose
Cohort 1: Renal Clearance (CLR) of Metformin in Urine	Up to approximately Day 16 post dose
Cohort 2: AUC (0-T) of Probe Substrate With Repotrectinib	Up to approximately Day 17 post dose	Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)
Cohort 2: AUC (0-T) of Probe Substrate Without Repotrectinib	Up to approximately Day 17 post dose	Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)
Cohort 2: AUC (INF) of Probe Substrate With Repotrectinib	Up to approximately Day 17 post dose	Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)
Cohort 2: AUC (INF) of Probe Substrate Without Repotrectinib	Up to approximately Day 17 post dose	Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)
Cohort 2: Cmax of Probe Substrate With Repotrectinib	Up to approximately Day 17 post dose	Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)
Cohort 2: Cmax of Probe Substrate Without Repotrectinib	Up to approximately Day 17 post dose	Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events (AEs)	Up to approximately Day 45 post dose
Number of Participants with Serious Adverse Events (SAEs)	Up to approximately Day 45 post dose
Number of Participants With Clinically Significant Physical Examination Findings	Up to approximately Day 17 post dose
Number of Participants With Clinically Significant Vital Sign Measurements	Up to approximately Day 17 post dose
Number of Participants With Clinically Significant 12-lead Electrocardiogram (12-lead ECG) Findings	Up to approximately Day 17 post dose
Number of Participants With Clinically Significant Safety Laboratory Test Results	Up to approximately Day 17 post dose