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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 days 1 to 11
Awards & highlights

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~days 1 to 11
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1 to 11 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Maximum observed plasma concentration (Cmax)
+1 more
Secondary outcome measures
Number of participants with Adverse Events (AEs)
Number of participants with Severe Adverse Events (SAEs)
Number of participants with clinical safety laboratory test abnormalities
+3 more

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
2,652 Previous Clinical Trials
4,130,725 Total Patients Enrolled
~16 spots leftby Jul 2025