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Voriconazole and Quinidine with Repotrectinib for Healthy Subjects
Phase 1
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Must not have
Gilbert's syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see how taking voriconazole or quinidine with repotrectinib affects how the drug moves through the body in healthy men and women who cannot get pregnant.
Who is the study for?
This trial is for healthy adult men and women who cannot become pregnant. Participants must not have any significant health issues that could interfere with the study or be taking medications that might interact with the drugs being tested.
What is being tested?
The study is testing how repotrectinib, a medication, behaves in the body when taken with either voriconazole or quinidine. It's to see if these other drugs change how much repotrectinib gets into the bloodstream and how long it stays there.
What are the potential side effects?
Possible side effects of repotrectinib may include dizziness, fatigue, constipation, while voriconazole can cause visual changes and skin reactions. Quinidine might lead to nausea or heart-related issues.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have Gilbert's syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Part 2Experimental Treatment2 Interventions
Group II: Part 1Experimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Voriconazole
2008
Completed Phase 4
~5740
Quinidine
2012
Completed Phase 1
~610
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,696 Previous Clinical Trials
4,099,039 Total Patients Enrolled