Assessing drug levels of repotrectinib in healthy individuals and those with liver impairment
A Phase 1, Multicenter, Open-label, Single-dose Study to Assess the Pharmacokinetics of Repotrectinib in Healthy Participants and Those With Moderate and Severe Hepatic Impairment
This study is testing how well the drug repotrectinib is processed in people with liver problems compared to healthy individuals to help guide safe dosing for those with liver issues.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | repotrectinib |
| Locations | 6 sites (Miami Lakes, Florida and 5 other locations) |
| Trial ID | NCT06352528 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with moderate to severe hepatic impairment or healthy individuals with normal liver function.
Not a fit: Patients with mild hepatic impairment or those with significant comorbid conditions that could interfere with study evaluations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective dosing guidelines for patients with liver impairment who require treatment with repotrectinib.
How similar studies have performed: While studies assessing drug levels in hepatic impairment are common, the specific evaluation of repotrectinib in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Miami Lakes, Florida and 5 other locations
- Local Institution - 0006 — Miami Lakes, Florida, United States (Withdrawn)
- Panax Clinical Research — Miami Lakes, Florida, United States (Recruiting)
- Local Institution - 0005 — Orlando, Florida, United States (Withdrawn)
- Orlando Clinical Research Center — Orlando, Florida, United States (Recruiting)
- Local Institution - 0004 — San Antonio, Texas, United States (Withdrawn)
- Texas Liver Institute — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact http://www.bmsstudyconnect.com/
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.