Assessing drug levels of repotrectinib in healthy individuals and those with liver impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the pharmacokinetics of a single oral dose of repotrectinib in participants with moderate and severe hepatic impairment compared to healthy volunteers. The trial includes adult participants with varying degrees of liver function, specifically targeting those with chronic liver disease or cirrhosis. By measuring drug levels, the study aims to understand how liver function affects the metabolism of repotrectinib, which could inform dosing recommendations for patients with hepatic impairment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

- Inclusion Criteria for all Participants (Group 1, Group 2, Group 3):.

i) Adult female (as assigned at birth) not of childbearing potential or male (as assigned at birth) of any race or ethnicity.

ii) Must have a body mass index between 18 and 40 kg/m2 (inclusive) and body weight ≥ 50 kg at the time of signing the ICF.

- Inclusion Criteria for Participants with Moderate or Severe Hepatic Impairment (Group 1 and Group 2):.

i) Participants have moderate or severe HI or cirrhosis due to chronic hepatic disease and/or prior alcohol use.

ii) Participants have moderate (Group 1), or severe (Group 2) HI as defined by Child-Pugh score.

- Inclusion Criteria for a Matched Healthy Participant (Group 3):.

i) Participant must be free of any clinically significant disease that would interfere with the study evaluations.

ii) Participant must have liver-related laboratory test results within the respective reference ranges or with clinically insignificant excursions therefrom as agreed by the investigator.

iii) Participant 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:

- Exclusion Criteria for all Participants (Group 1, Group 2, and Group 3):.

i) Any major surgery within 4 weeks of the study intervention administration.

ii) History of drug abuse within 1 year of study intervention administration.

iii) History of alcohol abuse within 1 year of study intervention administration.

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

- Other protocol-defined Inclusion/Exclusion criteria apply.

Where it's running

• Panax Clinical Research
  Miami Lakes, Florida, United States Recruiting
• Orlando Clinical Research Center
  Orlando, Florida, United States Recruiting
• Texas Liver Institute
  San Antonio, Texas, United States Recruiting
• Local Institution - 0006
  Miami Lakes, Florida, United States Withdrawn
• Local Institution - 0005
  Orlando, Florida, United States Withdrawn
• Local Institution - 0004
  San Antonio, Texas, United States Withdrawn

Study contacts

• Study coordinator: BMS Study Connect Contact http://www.bmsstudyconnect.com/
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.