Actively Recruiting
Pharmacokinetics of Olverembatinib in Participants With Hepatic Impairment
Led by Ascentage Pharma Group Inc. · Updated on 2025-12-23
48
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
Sponsors
A
Ascentage Pharma Group Inc.
Lead Sponsor
G
Guangzhou Healthquest Pharma Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a non-randomized, open-label, parallel, single-dose study to evaluate the pharmacokinetic profile of olverembatinib in participants with normal or impaired liver function.
CONDITIONS
Official Title
Pharmacokinetics of Olverembatinib in Participants With Hepatic Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 75 years
- Voluntary participation with signed informed consent and good compliance
- Body Mass Index between 18 and 30 kg/m²; male weight ≥ 50 kg, female weight ≥ 45 kg
- Suitable for study based on physical exam, vital signs, lab tests, and ECG
- Female participants of childbearing potential must use effective contraception during and 3 months after the study, have a negative pregnancy test within 7 days prior, and not be breastfeeding; males must use effective contraception during and 3 months after the study
- For hepatic impairment group: chronic liver impairment from viral hepatitis, alcoholic liver disease, autoimmune hepatitis, or other causes
- Hepatic impairment classified as Child-Pugh Class A, B, or C
- Coagulation function with INR ≤ 2.5 without procoagulant drugs
- Hematology: Neutrophils ≥ 1.0 × 10⁹/L, Hemoglobin ≥ 70 g/L, Platelets ≥ 30 × 10⁹/L
- Liver enzymes ALT and AST ≤ 5 times upper limit of normal; Total Bilirubin ≤ 5 times upper limit of normal
- Stable treatment for hepatic impairment and related conditions for at least 4 weeks prior to dosing
You will not qualify if you...
- Drug-induced liver injury
- History of liver transplant or acute/worsening liver injury, liver failure, or severe liver-related conditions
- Active Grade 3/4 hepatic encephalopathy
- Active hepatocellular carcinoma lesions
- Severe esophageal or gastric varices or history of rupture and bleeding
- Severe or late-stage ascites or pleural effusion requiring intervention
- Hepatorenal syndrome or other investigator-deemed unsuitable conditions
- History of cholestasis, biliary tract infection, or diseases affecting bile excretion within 3 months
- Esophageal or gastric variceal bleeding or portosystemic shunt surgery within specified timeframes
- History of significant allergies or intolerances
- Significant diseases affecting neurological, cardiovascular, digestive, respiratory, urinary, endocrine, hematological, or immune systems
- History of surgery affecting drug metabolism or plans for surgery during study
- Uncontrolled infections requiring treatment or recent severe infections
- Positive HIV test; positive syphilis or other infections as applicable
- Use of hepatotoxic systemic medications for ≥7 days within 14 days prior to dosing
- Use of traditional Chinese medicine, supplements, or vitamins within 14 days prior
- Use of moderate or potent CYP3A4 inhibitors or inducers within 14 days prior
- Positive drug or alcohol test at screening
- Excessive alcohol intake or inability to abstain during study
- Consumption of substances or activities affecting drug metabolism within 7 days prior and inability to abstain
- Participation in other clinical trials recently or excessive trial participation history
- Significant blood loss, transfusions, or blood donation within 3 months
- Needle or blood phobia or difficulty with blood collection
- Unwillingness or inability to comply with study procedures
- For normal hepatic function group: history or evidence of hepatitis B or C, hepatic impairment, or positive hepatitis B or C markers at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Suzhou Medical University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
Y
Yifan Zhai, M.D., Ph.D.
CONTACT
X
Xiang Xu, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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