A Study to Assess the Effect of Voriconazole and Quinidine on the Pharmacokinetics of a Single Dose of Repotrectinib in Healthy Participants
Completed · Phase 1
Conditions studied: Healthy Volunteers
In brief
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 facts
- Study ID
- NCT06493409
- Run by
- Bristol-Myers Squibb
- People needed
- 32
- Starts
- 2024-08-26
- Expected to finish
- 2024-12-07
- Last updated by the study team
- 2025-08-22
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
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.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Where it is running
- Fortrea - Daytona Beach — Daytona Beach, Florida, United States
Full record on ClinicalTrials.gov
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