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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Specified dose on specified days
Panax Clinical Research
Miami Lakes, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
The Texas Liver Institute, Inc.
San Antonio, Texas, United States
Maximum observed plasma concentration (Cmax)
Time frame: Days 1 to 11
Time of maximum observed plasma concentration (Tmax)
Time frame: Days 1 to 11
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Days 1 to 11
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Days 1 to 11
Number of participants with Adverse Events (AEs)
Time frame: Up to 28 days following last dose
Number of participants with Severe Adverse Events (SAEs)
Time frame: Up to 28 days following last dose
Number of participants with physical examination abnormalities
Time frame: Up to Day 11
Number of participants with vital sign abnormalities
Time frame: Up to Day 11
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to Day 11
Number of participants with clinical safety laboratory test abnormalities
Time frame: Up to Day 11
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