Vorolanib PK study in people with liver impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, non-randomized, open-label study in healthy volunteers and participants with hepatic impairment. It uses a parallel-group design to assess the pharmacokinetics and safety of a 200 mg oral dose of vorolanib given after a standard breakfast. The study enrolls 24 adults split into three groups: mild hepatic impairment, moderate hepatic impairment, and normal hepatic function, with PK blood samples and safety monitoring collected around dosing. The aim is to understand how hepatic impairment affects vorolanib exposure and tolerability.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Hospital of Jilin University
  Changchun, Jilin, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.