Repotrectinib for Liver Disease

Recruiting at 5 trial locations

Overseen By Eric Lawitz, Site 0002

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Disqualifiers: Major surgery, Drug abuse, Alcohol abuse, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

24 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What is the purpose of this trial?

The purpose of this study is to assess the drug levels of a single oral dose of repotrectinib in participants with moderate and severe HI, and in healthy matched control participants with normal hepatic function.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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.

Inclusion Criteria

Matched healthy participants (Group 3) must have liver-related laboratory test results within the respective reference ranges or with clinically insignificant excursions therefrom as agreed by the investigator

I am healthy with no significant diseases affecting study participation.

Matched healthy participants (Group 3) must be in good health as determined by past medical history, physical examination, vital signs, ECG, and clinical laboratory safety tests. Clinical laboratory safety tests (eg, hematology, chemistry, and urinalysis) and 12-lead ECGs must be within normal limits or clinically acceptable as judged by the investigator

Exclusion Criteria

History of drug abuse within 1 year of study intervention administration

Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1

History of alcohol abuse within 1 year of study intervention administration

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single oral dose of repotrectinib

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Repotrectinib

Trial Overview 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.

Participant Groups

Group I: Group 3: Normal Hepatic Function Experimental Treatment 1 Intervention

Group II: Group 2: Severe Hepatic Impairment Experimental Treatment 1 Intervention

Group III: Group 1: Moderate Hepatic Impairment Experimental Treatment 1 Intervention

Repotrectinib is already approved in United States for the following indications:

Approved in United States as Augtyro for:

• ROS1-positive non-small cell lung cancer (NSCLC)
• Solid tumors caused by certain abnormal NTRK genes

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania