Skip to main content
OpenTrials
Completed

NCT Number: NCT06493409

A Study to Assess the Effect of Voriconazole and Quinidine on the Pharmacokinetics of a Single Dose of Repotrectinib in Healthy Participants

The purpose of this study is to evaluate the effects of coadministration of voriconazole or quinidine on the pharmacokinetics (PK) of repotrectinib in healthy male and female (individual not of childbearing potential [INOCBP]) participants.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea - Daytona Beach

Daytona Beach, Florida, 32117, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male and female individual(s) not of childbearing potential (INOCBP) participants of any race or ethnicity, as determined by no clinically significant findings in medical history, physical examination, 12-lead ECG, or vital signs as determined by the investigator or designee.
  • Potassium, magnesium, and calcium at or above the lower limit of normal. For other clinical laboratory parameters, no clinically significant findings as determined by the investigator or designee.
  • Must have a body mass index between 18 and 30 kg/m2 (inclusive) and body weight ≥ 50 kg at the time of signing the ICF.

Exclusion criteria

  • History of clinically significant acute or chronic medical illness, such as endocrine, gastrointestinal (GI), cardiovascular, peripheral vascular, hematological, hepatic, immunological, renal, respiratory, neoplastic, or genitourinary abnormalities/diseases as determined by the investigator or designee.
  • History of GI disease or surgery that could possibly affect drug absorption, distribution, metabolism, and excretion (ADME) (eg, bariatric procedure, cholecystectomy). Uncomplicated appendectomy and hernia repair are acceptable.
  • Gilbert's syndrome.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment and study plan

Repotrectinib

Drug

Specified dose on specified days

Other names: BMS-986472

Voriconazole

Drug

Specified dose on specified days

Quinidine

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to Day 23

  2. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

    Time frame: Up to Day 23

  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

    Time frame: Up to Day 23

Secondary outcomes

  1. Number of participants with Adverse Events (AEs)

    Time frame: Up to Day 52

  2. Number of participants with Severe Adverse Events (SAEs)

    Time frame: Up to Day 52

  3. Number of participants with physical examination abnormalities

    Time frame: Up to Day 23

  4. Number of participants with vital sign abnormalities

    Time frame: Up to Day 23

  5. Number of participants with electrocardiogram abnormalities

    Time frame: Up to Day 23

  6. Number of participants with clinical safety laboratory test abnormalities

    Time frame: Up to Day 22

  7. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to Day 23

  8. Apparent terminal phase half-life (T-HALF)

    Time frame: Up to Day 23

  9. Apparent total body clearance (CLT/F)

    Time frame: Up to Day 23

  10. Apparent volume of distribution of terminal phase (Vz/F)

    Time frame: Up to Day 23

  11. Cmax

    Time frame: Up to Day 23

  12. Area under the plasma concentration-time curve over one dosing interval (AUC(TAU))

    Time frame: Up to Day 23

  13. Trough observed plasma concentration (Ctrough)

    Time frame: Up to Day 23

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase I, Two-part, Single-center, Open-label, Drug-drug Interaction Study to Assess the Effect of Voriconazole (Part 1) and Quinidine (Part 2) on the Pharmacokinetics of a Single Dose of Repotrectinib (BMS-986472) in Healthy Participants

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 10, 2024
Registry last updated
Aug 22, 2025

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.

Published trials that share one or more normalized conditions with this study.