This is a single-center, non-randomized, open-label, parallel-group, single-dose study designed to evaluate the safety and pharmacokinetic (PK) profile of vorolanib tablets in participants with hepatic impairment. A total of 24 participants (male and female) will be enrolled. Three study groups will be established, comprising participants with mild hepatic impairment (Child-Pugh A), moderate hepatic impairment (Child-Pugh B), and normal hepatic function, respectively. All participants will receive a single oral dose of 200 mg vorolanib tablets after a standard breakfast (regular meal) on Day 1 (D1). PK blood sampling and safety assessments will be performed at protocol-specified time points before and after drug administration for each participant.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
36
a single oral dose of 200 mg
a single oral dose of 200 mg
a single oral dose of 200 mg
The First Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGMaximum observed plasma concentration(Cmax)
Time frame: From pre-dose to 120 hours post-dose
Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC₀-t)
Time frame: From pre-dose to 120 hours post-dose
Area under the plasma concentration-time curve from time 0 to infinity (AUC₀-∞)
Time frame: From pre-dose to 120 hours post-dose
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