Assessing how voriconazole and quinidine affect repotrectinib in healthy individuals
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
This study is testing how the drugs voriconazole and quinidine affect the way the body processes repotrectinib in healthy volunteers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | repotrectinib |
| Locations | 1 site (Daytona Beach, Florida) |
| Trial ID | NCT06493409 on ClinicalTrials.gov |
What this trial studies
This study evaluates the pharmacokinetics of repotrectinib when administered alongside voriconazole or quinidine in healthy participants. It aims to understand how these drugs interact and influence the absorption and metabolism of repotrectinib. The study involves healthy male and female volunteers who meet specific health criteria and will be monitored for their responses to the drug combinations. The findings could provide insights into safe and effective dosing strategies for future treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy male and female individuals not of childbearing potential, aged 18-65, with a BMI between 18 and 30 kg/m2.
Not a fit: Patients with a history of significant medical illnesses or those with gastrointestinal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of drug interactions, leading to safer medication regimens for patients requiring repotrectinib.
How similar studies have performed: Other studies have shown success in evaluating drug interactions in healthy volunteers, making this approach well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Daytona Beach, Florida
- Fortrea - Daytona Beach — Daytona Beach, Florida, United States (Recruiting)
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.