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
NCT ID NCT07809802
First seen Sep 09, 2026 · Last updated Sep 09, 2026
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Hospital of Jilin University
RECRUITINGChangchun, Jilin, 130000, China
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