A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment
- Registration Number
- NCT06352528
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 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 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group 1: Moderate Hepatic Impairment Repotrectinib - Group 2: Severe Hepatic Impairment Repotrectinib - Group 3: Normal Hepatic Function Repotrectinib -
- Primary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) Days 1 to 11 Time of maximum observed plasma concentration (Tmax) Days 1 to 11 Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) Days 1 to 11 Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) Days 1 to 11
- Secondary Outcome Measures
Name Time Method Number of participants with Adverse Events (AEs) Up to 28 days following last dose Number of participants with Severe Adverse Events (SAEs) Up to 28 days following last dose Number of participants with physical examination abnormalities Up to Day 11 Number of participants with vital sign abnormalities Up to Day 11 Number of participants with clinical safety laboratory test abnormalities Up to Day 11 Number of participants with electrocardiogram (ECG) abnormalities Up to Day 11
Trial Locations
- Locations (6)
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States
Local Institution - 0005
🇺🇸Orlando, Florida, United States
Local Institution - 0006
🇺🇸Miami Lakes, Florida, United States
Local Institution - 0004
🇺🇸San Antonio, Texas, United States
Texas Liver Institute
🇺🇸San Antonio, Texas, United States
Panax Clinical Research
🇺🇸Miami Lakes, Florida, United States