Hepatic Impairment (HI)
Conditions
Brief summary
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.
Sponsors
Betta Pharmaceuticals Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 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; Trial participants with normal liver function must additionally meet all of the following criteria: * 3\. Meet the following demographic matching criteria at screening: 1. Weight-matched to the hepatic impairment group within ±10 kg of the mean value; 2. Age-matched to the hepatic impairment group within ±10 years of the mean value; 3. Sex-matched to the hepatic impairment group with a difference of ≤1 participant per sex; Trial participants with hepatic impairment must additionally meet all of the following criteria: * 4\. Patients with hepatic insufficiency of Child-Pugh Class A or B and chronic liver injury caused by primary liver diseases (e.g., hepatitis B, hepatitis C, autoimmune hepatitis, alcoholic liver disease, etc.); * 5\. Clinically diagnosed cirrhosis.
Exclusion criteria
Trial participants with normal liver function will be excluded if they meet any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration(Cmax) | 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) | From pre-dose to 120 hours post-dose |
| Area under the plasma concentration-time curve from time 0 to infinity (AUC₀-∞) | From pre-dose to 120 hours post-dose |
Countries
China
Outcome results
None listed