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.
1. Voluntarily sign the informed consent form prior to initiation of any trial-related activities, understand the trial procedures and methods, and agree to complete the trial in strict accordance with the clinical trial protocol;
2. Trial participants (including their partners) agree not to conceive, donate sperm or oocytes from screening through 6 months after administration of the investigational product, and are willing to use highly effective contraceptive measures;
Weight-matched to the hepatic impairment group within ±10 kg of the mean value;
Age-matched to the hepatic impairment group within ±10 years of the mean value;
1. A history of liver injury;
2. Presence of any clinically significant prior or current disease of the circulatory, endocrine, nervous, digestive, respiratory, hematologic, immunologic or psychiatric system, metabolic disorders, or any other disease that may interfere with trial results;
3. Abnormal findings on physical examination, vital signs, laboratory tests, 12-lead electrocardiogram or abdominal ultrasonography judged clinically significant by the investigator;
4. The participant has any of the following conditions: acute liver injury of any etiology; history of liver transplantation; or cirrhosis complicated with the following complications deemed ineligible for enrollment by the investigator, including but not limited to liver failure, hepatic encephalopathy, hepatocellular carcinoma (except for Barcelona Clinic Liver Cancer Stage 0 or patients with curative treatment outcome), variceal bleeding of esophageal and gastric fundus occurring within 3 months prior to screening, confirmed hepatorenal or hepatopulmonary syndrome, and severe ascites or pleural effusion requiring puncture and drainage;
Parallel
vorolanib
Druga single oral dose of 200 mg
vorolanib
Druga single oral dose of 200 mg
Vorolanib
Druga single oral dose of 200 mg
Maximum observed plasma concentration(Cmax)
Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC₀-t)
Area under the plasma concentration-time curve from time 0 to infinity (AUC₀-∞)
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