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OpenTrials
Completed

NCT Number: NCT07223671

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Daytona Beach, Florida, 32117-5116, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Repotrectinib

Drug

Specified dose on specified days

metformin

Drug

Specified dose on specified days

Digoxin

Drug

Specified dose on specified days

Rosuvastatin

Drug

Specified dose on specified days

bupropion

Drug

Specified dose on specified days

Flurbiprofen

Drug

Specified dose on specified days

Omeprazole

Drug

Specified dose on specified days

Primary outcomes

  1. 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

    Time frame: Up to approximately Day 17 post dose

    Probe substrate contains metformin, digoxin, and rosuvastatin.

  2. Cohort 1: AUC (0-T) of Probe Substrate Without Repotrectinib

    Time frame: Up to approximately Day 17 post dose

    Probe substrate contains metformin, digoxin, and rosuvastatin.

  3. Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of Probe Substrate With Repotrectinib

    Time frame: Up to approximately Day 17 post dose

    Probe substrate contains metformin, digoxin, and rosuvastatin.

  4. Cohort 1: AUC(INF) of Probe Substrate Without Repotrectinib

    Time frame: Up to approximately Day 17 post dose

    Probe substrate contains metformin, digoxin, and rosuvastatin.

  5. Cohort 1: Maximum Observed Plasma Concentration (Cmax) of Probe Substrate With Repotrectinib

    Time frame: Up to approximately Day 17 post dose

    Probe substrate contains metformin, digoxin, and rosuvastatin

  6. Cohort 1: Cmax of Probe Substrate Without Repotrectinib

    Time frame: Up to approximately Day 17 post dose

    Probe substrate contains metformin, digoxin, and rosuvastatin

  7. Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero to 48 Hours Post Dose (AUC (0-48)) of Metformin With Repotrectinib

    Time frame: Up to approximately Day 17 post dose

  8. Cohort 1: AUC (0-48) of Metformin Without Repotrectinib

    Time frame: Up to approximately Day 17 post dose

  9. Cohort 1: Renal Clearance (CLR) of Metformin in Urine

    Time frame: Up to approximately Day 16 post dose

  10. Cohort 2: AUC (0-T) of Probe Substrate With Repotrectinib

    Time frame: Up to approximately Day 17 post dose

    Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)

  11. Cohort 2: AUC (0-T) of Probe Substrate Without Repotrectinib

    Time frame: Up to approximately Day 17 post dose

    Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)

  12. Cohort 2: AUC (INF) of Probe Substrate With Repotrectinib

    Time frame: Up to approximately Day 17 post dose

    Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)

  13. Cohort 2: AUC (INF) of Probe Substrate Without Repotrectinib

    Time frame: Up to approximately Day 17 post dose

    Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)

  14. Cohort 2: Cmax of Probe Substrate With Repotrectinib

    Time frame: Up to approximately Day 17 post dose

    Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)

  15. Cohort 2: Cmax of Probe Substrate Without Repotrectinib

    Time frame: Up to approximately Day 17 post dose

    Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)

Secondary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Up to approximately Day 45 post dose

  2. Number of Participants with Serious Adverse Events (SAEs)

    Time frame: Up to approximately Day 45 post dose

  3. Number of Participants With Clinically Significant Physical Examination Findings

    Time frame: Up to approximately Day 17 post dose

  4. Number of Participants With Clinically Significant Vital Sign Measurements

    Time frame: Up to approximately Day 17 post dose

  5. Number of Participants With Clinically Significant 12-lead Electrocardiogram (12-lead ECG) Findings

    Time frame: Up to approximately Day 17 post dose

  6. Number of Participants With Clinically Significant Safety Laboratory Test Results

    Time frame: Up to approximately Day 17 post dose

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 3, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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