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Tyrosine Kinase Inhibitor
Repotrectinib for Liver Disease
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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to measure the levels of a drug called repotrectinib in people with liver conditions and compare it to those with normal liver function after taking a single dose by mouth.
Who is the study for?
This trial is for adults with moderate to severe liver impairment and healthy individuals with normal liver function. Participants will be matched based on certain characteristics like age, weight, and gender.
What is being tested?
The study is testing how a single oral dose of the drug Repotrectinib behaves in the body in people with different levels of liver health compared to those who are healthy.
What are the potential side effects?
Specific side effects of Repotrectinib aren't listed here, but they may include typical drug reactions such as nausea, headache, dizziness or allergic responses.
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
3Treatment groups
Experimental Treatment
Group I: Group 3: Normal Hepatic FunctionExperimental Treatment1 Intervention
Group II: Group 2: Severe Hepatic ImpairmentExperimental Treatment1 Intervention
Group III: Group 1: Moderate Hepatic ImpairmentExperimental Treatment1 Intervention
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,681 Previous Clinical Trials
4,125,186 Total Patients Enrolled
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