This is a non-randomized, open-label, parallel, single-dose study to evaluate the pharmacokinetic profile of olverembatinib in participants with normal or impaired liver function.
To evaluate the PK characteristics of olverembatinib in participants with mild hepatic impairment (Child-Pugh Class A), moderate hepatic impairment (Child-Pugh Class B), severe hepatic impairment (Child-Pugh Class C) and sex, age, and body weight-matched healthy participants with normal hepatic function, so as to provide a scientific basis for the appropriate dose and/or dosing interval adjustment in participants with hepatic impairment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
orally after meal, single dose
The First Affiliated Hospital of Suzhou Medical University
Suzhou, Jiangsu, China
RECRUITINGMaximum observed plasma concentration C(max)
The C(max) of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
Time frame: Day 1 to Day 9
Time to C(max) [ t(max) ]
The t(max) of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
Time frame: Day 1 to Day 9
Apparent terminal elimination half-life (t½)
The t½ of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
Time frame: Day 1 to Day 9
Area under the concentration-time curve from time zero to last time of quantifiable concentration [AUC(last)]
The AUC(last) of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
Time frame: Day 1 to Day 9
Area under the concentration-time curve from time zero to 192h AUC(0-192h)
The AUC(0-192h) of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
Time frame: Day 1 to Day 9
Apparent Clearance (CL/F)
The CL/F of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
Time frame: Day 1 to Day 9
Apparent Volume of distribution (Vz/F)
The Vz/F of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
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Time frame: Day 1 to Day 9
Unbound Fraction (fu)
The unbound fraction (fu) of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
Time frame: Day 1 to Day 9
Safety evaluation endpoints
Incidence of treatment-related adverse events, abnormalities in clinical laboratory, vital signs and electrocardiogram (ECG) as assessed by CTCAE v5.0. According to CTCAE v5.0, the number and frequency of adverse events after a single dose of test drug were assessed.
Time frame: Day1-Day21