A Study to Assess the Effect of Voriconazole and Quinidine on the Pharmacokinetics of a Single Dose of Repotrectinib in Healthy Participants
Phase 1
Recruiting
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT06493409
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- 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 Part 1 Repotrectinib - Part 2 Repotrectinib - Part 1 Voriconazole - Part 2 Quinidine -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 Apparent volume of distribution of terminal phase (Vz/F) Up to Day 23 Cmax 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 Number of participants with clinical safety laboratory test abnormalities Up to Day 22 Apparent terminal phase half-life (T-HALF) Up to Day 23 Apparent total body clearance (CLT/F) Up to Day 23 Trough observed plasma concentration (Ctrough) Up to Day 23 Time of maximum observed plasma concentration (Tmax) Up to Day 23 Area under the plasma concentration-time curve over one dosing interval (AUC(TAU)) Up to Day 23
Trial Locations
- Locations (1)
Fortrea - Daytona Beach
🇺🇸Daytona Beach, Florida, United States