Healthy Volunteers, Hepatic Impairment
Conditions
Keywords
Hepatic Impairment, Healthy Volunteers, Severe, BMS-986472, Repotrectinib, Liver Diseases, Pharmacokinetics
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.
Interventions
DRUGRepotrectinib
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of participants with electrocardiogram (ECG) abnormalities | Up to Day 11 |
| Number of participants with Adverse Events (AEs) | Up to 28 days following last dose |
| Number of participants with clinical safety laboratory test abnormalities | Up to Day 11 |
| 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 |
Countries
United States
Outcome results
None listed