Hepatic Impairment (HI)Phase 1NCT07809802
Pharmacokinetic Study of Vorolanib Tablets in Trial Participants With Hepatic Impairment
A Phase 1 study testing vorolanib in people with Hepatic Impairment (HI), run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment (HI)
- What is being tested?
- vorolanib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Jun 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- 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;
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- 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.
Who cannot join
- Trial participants with normal liver function will be excluded if they meet any of the following exclusion criteria:
- 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;
- Trial participants with hepatic impairment will be excluded if they meet any of the following exclusion criteria:
- 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;
- 5. Any of the following laboratory findings at screening: (a) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >10×ULN; (b) absolute neutrophil count (NE#) <0.75×10⁹/L; (c) hemoglobin (HGB) <60 g/L; (d) alpha-fetoprotein (AFP) >100 ng/mL; (e) platelet count <40×10⁹/L.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130000
Hong Zhang, 86-0431-88782705, jhongzhang@foxmail.com
About this study
Official title: Phase I Clinical Study to Compare and Evaluate the Pharmacokinetics and Safety of Orally Administered Vorolanib Tablets in Participants With Mild (Child-Pugh A) or Moderate (Child-Pugh B) Hepatic Impairment and Participants With Normal Hepatic Function
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.
- Conditions
- Hepatic Impairment (HI)
- Being tested
- vorolanib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vorolanibDrug
a single oral dose of 200 mg
vorolanibDrug
a single oral dose of 200 mg
VorolanibDrug
a single oral dose of 200 mg
| Study group | Role | What they receive |
|---|---|---|
| Participants with mild hepatic impairment (Child-Pugh A) | Experimental | a single oral dose of 200 mg vorolanib tablets after a standard breakfast (regular meal) on Day 1 Receives: Drug: vorolanib |
| Participants with moderate hepatic impairment (Child-Pugh B) | Experimental | a single oral dose of 200 mg vorolanib tablets after a standard breakfast (regular meal) on Day 1 Receives: Drug: vorolanib |
| Participants with normal hepatic function | Experimental | a single oral dose of 200 mg vorolanib tablets after a standard breakfast (regular meal) on Day 1 Receives: Drug: Vorolanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration(Cmax)
Measured: 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)
Measured: From pre-dose to 120 hours post-dose
Area under the plasma concentration-time curve from time 0 to infinity (AUC₀-∞)
Measured: From pre-dose to 120 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Impairment (HI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809802
- Sponsor's protocol ID
- CM082-CA-I-111
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No