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

NCT06493409 | Completed Phase 1 FDA Drug

• 1 other identifier: CA127-1072
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

drug interaction; healthy; repotrectinib; BMS-986472; pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• Maximum observed plasma concentration (Cmax)

  Up to Day 23

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

  Up to Day 23

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

  Up to Day 23

Secondary Outcomes (13)

• Number of participants with Adverse Events (AEs)

  Up to Day 52

• Number of participants with Severe Adverse Events (SAEs)

  Up to Day 52

• Number of participants with physical examination abnormalities

  Up to Day 23

• Number of participants with vital sign abnormalities

  Up to Day 23

• Number of participants with electrocardiogram abnormalities

  Up to Day 23

Study Arms (2)

Part 1

EXPERIMENTAL

Drug: Repotrectinib; Drug: Voriconazole

Part 2

EXPERIMENTAL

Drug: Repotrectinib; Drug: Quinidine

Interventions

Repotrectinib DRUG

Specified dose on specified days

Also known as: BMS-986472

Part 1; Part 2

Voriconazole DRUG

Specified dose on specified days

Part 1

Quinidine DRUG

Specified dose on specified days

Part 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Fortrea - Daytona Beach

Daytona Beach, Florida, 32117, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

repotrectinib; Voriconazole; Quinidine

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cinchona Alkaloids; Alkaloids; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 10, 2024
• Study Start: August 26, 2024
• Primary Completion: December 7, 2024
• Study Completion: December 7, 2024
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (1)