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

Part of paid clinical trials in Daytona Beach, Florida.

Sponsor
Bristol-Myers Squibb
Study ID
NCT06493409
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Repotrectinib — DRUG
    Specified dose on specified days
  • Voriconazole — DRUG
    Specified dose on specified days
  • Quinidine — DRUG
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
Aug 26, 2024
Status verified
Aug 2025
Primary completion
Dec 7, 2024
Completion
Dec 7, 2024

Study Design

Enrollment
32 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1
  • Experimental: Part 2

Primary Outcome Measure

Maximum observed plasma concentration (Cmax) [ Time Frame: Up to Day 23 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fortrea - Daytona BeachDaytona BeachFlorida32117-

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