PharmacokineticPhase 1NCT07282093
Pharmacokinetics of Olverembatinib in Participants With Hepatic Impairment
A Phase 1 study testing Olverembatinib 20mg in people with Pharmacokinetic and Olverembatinib, run by Ascentage Pharma Group Inc. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetic, Olverembatinib
- What is being tested?
- Olverembatinib 20mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2025to 31 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The participant voluntarily joins the study, signs the Informed Consent Form, and demonstrates good compliance.
- Body Mass Index (BMI) between 18 and 30 kg/m² (inclusive), with male weight ≥ 50 kg and female weight ≥ 45 kg.
- The investigator judges the participant suitable to participate in this study based on physical examination, vital signs, laboratory tests, and 12-lead electrocardiogram (ECG) examination.
- Female participants of childbearing potential must agree to use effective contraception during the study and for 3 months after the study ends; must have a negative serum pregnancy test within 7 days prior to study enrollment; and must not be breastfeeding. Male participants must agree to use effective contraception during the study and for 3 months after the study ends.
- Additional Criteria for Participants with hepatic impairment Only:
- 1. Chronic hepatic impairment due to viral hepatitis, alcoholic liver disease, autoimmune hepatitis, or other causes.
- 2. Hepatic impairment classified as Child-Pugh Class A, B, or C. 3. Coagulation function: INR ≤ 2.5 without intervention with procoagulant drugs (after a 2-week washout period). Hematology: Neutrophils ≥ 1.0 × 10⁹/L, Hemoglobin ≥ 70 g/L, Platelets ≥ 30 × 10⁹/L. Liver function: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 5 times the Upper Limit of Normal (ULN); Total Bilirubin ≤ 5 × ULN.
- 4. Stable treatment for hepatic impairment, complications, and other concomitant diseases prior to study drug administration, with no need for dosage adjustment. Treatment for hepatic impairment must have been stable for at least 4 weeks.
Who cannot join
- Drug-induced liver injury.
- Any of the following conditions: history of liver transplantation; presence of acute or worsening liver injury due to any cause; liver failure; concurrent Grade 3/4 hepatic encephalopathy; active hepatocellular carcinoma lesions; severe esophageal or gastric varices or history of rupture and bleeding; severe/late-stage ascites or pleural effusion requiring paracentesis/thoracentesis and albumin supplementation; hepatorenal syndrome; or any other condition deemed by the investigator as unsuitable for study participation.
- History of cholestasis, biliary tract infection, or other diseases affecting bile excretion within 3 months prior to screening.
- Esophageal or gastric variceal bleeding due to portal hypertension within 3 months prior to screening, or history of portosystemic shunt surgery (including Transjugular Intrahepatic Portosystemic Shunt - TIPS) within 6 months prior to screening.
- History of significant allergy or intolerance to any drug, food, or other substance.
- History of any clinically significant disease in the neurological, cardiovascular, digestive, respiratory, urinary, endocrine, hematological, immune systems, or any other disease or condition that the investigator believes may affect the trial results.
Show all 21Show fewer
- History of surgery that may affect drug absorption, distribution, metabolism, or excretion, or plans for surgery or other reasons requiring hospitalization during the expected study period.
- Uncontrolled bacterial, viral, parasitic, or fungal infection requiring treatment at the time of screening (except Hepatitis B), or history of severe active infection within 1 month prior to screening.
- Positive Human Immunodeficiency Virus (HIV) antigen/antibody test at screening. For participants with normal hepatic function: Positive Treponema pallidum antibody. For hepatically impaired participants: Active syphilis.
- Use of systemic medications with known potential hepatotoxicity for 7 consecutive days or more within 14 days prior to study drug administration.
- Use of traditional Chinese medicine (herbal medicines, proprietary Chinese medicines), dietary supplements, or vitamins within 14 days prior to study drug administration.
- Systemic use of moderate or potent CYP3A4 inhibitors (e.g., itraconazole, fluconazole) or moderate or potent CYP3A4 inducers within 14 days prior to study drug administration.
- Positive urine drug screen or alcohol breath test at screening.
- Excessive alcohol intake (averaging more than 14 units of alcohol per week) within 3 months prior to screening, or inability to abstain from alcohol during the trial period.
- Consumption of grapefruit/juice, foods or beverages rich in methylxanthines, engagement in strenuous exercise, or presence of other factors affecting drug absorption, distribution, metabolism, or excretion within 7 days prior to study drug administration, and inability to abstain from these during the hospitalization period.
- Participation in other investigational drug or medical device clinical trials within 3 months prior to the first dose of the study drug, or participation in 3 or more drug or medical device clinical trials within the past year. If the half-life of the other investigational drug is long, a longer interval is required, at least 5 times the half-life of that drug.
- Blood donation (or blood loss) ≥ 400 mL, or receipt of blood transfusion or blood products within 3 months prior to screening.
- History of needle or blood phobia, difficulty with blood collection, or intolerance to venipuncture.
- Unwillingness or inability to comply with the study procedures outlined in the protocol, or any other reason considered by the investigator as unsuitable for participation in this clinical study.
- Additional Criteria for Participants with Normal Hepatic Function Only:
- 1). For participants with normal hepatic function: History of hepatitis, Hepatitis B, or Hepatitis C. History of hepatic impairment, or findings during screening physical examination or laboratory tests suggesting existing or potential hepatic impairment; Positive Hepatitis B Surface Antigen (HBsAg) or positive anti-HCV antibody.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xiang Xu, M.D. contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Suzhou Medical University
Suzhou, Jiangsu, 215006
Liyan Miao, M.D.,Ph.D., 0512-67972858, miaolysuzhou@163.com
Weifeng Zhao, M.D.,Ph.D.
About this study
Official title: An Open-Label, Phase 1 Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of Olverembatinib
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.
Read the detailed description
To evaluate the PK characteristics of olverembatinib in participants with mild hepatic impairment (Child-Pugh Class A), moderate hepatic impairment (Child-Pugh Class B), severe hepatic impairment (Child-Pugh Class C) and sex, age, and body weight-matched healthy participants with normal hepatic function, so as to provide a scientific basis for the appropriate dose and/or dosing interval adjustment in participants with hepatic impairment.
- Conditions
- Pharmacokinetic, Olverembatinib
- Being tested
- Olverembatinib 20mg
- Keywords
- olverembatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olverembatinib 20mgDrug
orally after meal, single dose
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 6-8 participants with mild hepatic impairment. | Experimental | Not described Receives: Drug: Olverembatinib 20mg |
| Group 2: 6-8 participants with normal hepatic function matched to Group 1 | Experimental | Not described Receives: Drug: Olverembatinib 20mg |
| Group 3: 6-8 participants with moderate hepatic impairment | Experimental | Not described Receives: Drug: Olverembatinib 20mg |
| Group 4: 6-8 participants with normal hepatic function matched to Group 3 | Experimental | Not described Receives: Drug: Olverembatinib 20mg |
| Group 5: 6-8 participants with severe hepatic impairment | Experimental | Not described Receives: Drug: Olverembatinib 20mg |
| Group 6: 6-8 participants with normal hepatic function matched to Group 5 | Experimental | Not described Receives: Drug: Olverembatinib 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration C(max)
The C(max) of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
Measured: Day 1 to Day 9
Time to C(max) [ t(max) ]
The t(max) of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
Measured: Day 1 to Day 9
Apparent terminal elimination half-life (t½)
The t½ of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
Measured: Day 1 to Day 9
Area under the concentration-time curve from time zero to last time of quantifiable concentration [AUC(last)]
The AUC(last) of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
Measured: Day 1 to Day 9
Area under the concentration-time curve from time zero to 192h AUC(0-192h)
The AUC(0-192h) of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
Measured: Day 1 to Day 9
Apparent Clearance (CL/F)
The CL/F of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
Measured: Day 1 to Day 9
Apparent Volume of distribution (Vz/F)
The Vz/F of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
Measured: Day 1 to Day 9
Unbound Fraction (fu)
The unbound fraction (fu) of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
Measured: Day 1 to Day 9
Secondary outcomes (1)
Safety evaluation endpoints
Incidence of treatment-related adverse events, abnormalities in clinical laboratory, vital signs and electrocardiogram (ECG) as assessed by CTCAE v5.0. According to CTCAE v5.0, the number and frequency of adverse events after a single dose of test drug were assessed.
Measured: Day1-Day21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start11 Nov 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticStudies of the same condition, open and under way.
- More trials run by Ascentage Pharma Group Inc.The sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ascentage Pharma Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guangzhou Healthquest Pharma Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Liyan Miao, M.D.,Ph.D., Principal investigator, M.D.,Ph.D.Weifeng Zhao, M.D.,Ph.D., Principal investigator, The First Affiliated Hospital of Suzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282093
- Sponsor's protocol ID
- HQP1351XC107
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase 1 Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of Olverembatinib
- ClinicalTrials.gov ID
- NCT07282093
- Acronym / sponsor ID
- HQP1351XC107
- Conditions
- Pharmacokinetic, Olverembatinib
- Keywords
- olverembatinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Ascentage Pharma Group Inc.Industry (pharma, biotech, devices)
- Collaborators
- Guangzhou Healthquest Pharma Co., Ltd
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To evaluate the PK characteristics of olverembatinib in participants with mild hepatic impairment (Child-Pugh Class A), moderate hepatic impairment (Child-Pugh Class B), severe hepatic impairment (Child-Pugh Class C) and sex, age, and body weight-matched healthy participants with normal hepatic function, so as to provide a scientific basis for the appropriate dose and/or dosing interval adjustment in participants with hepatic impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1: 6-8 participants with mild hepatic impairment. | Experimental | Drug: Olverembatinib 20mg |
| Group 2: 6-8 participants with normal hepatic function matched to Group 1 | Experimental | Drug: Olverembatinib 20mg |
| Group 3: 6-8 participants with moderate hepatic impairment | Experimental | Drug: Olverembatinib 20mg |
| Group 4: 6-8 participants with normal hepatic function matched to Group 3 | Experimental | Drug: Olverembatinib 20mg |
| Group 5: 6-8 participants with severe hepatic impairment | Experimental | Drug: Olverembatinib 20mg |
| Group 6: 6-8 participants with normal hepatic function matched to Group 5 | Experimental | Drug: Olverembatinib 20mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The participant voluntarily joins the study, signs the Informed Consent Form, and demonstrates good compliance.
- Body Mass Index (BMI) between 18 and 30 kg/m² (inclusive), with male weight ≥ 50 kg and female weight ≥ 45 kg.
- The investigator judges the participant suitable to participate in this study based on physical examination, vital signs, laboratory tests, and 12-lead electrocardiogram (ECG) examination.
- Female participants of childbearing potential must agree to use effective contraception during the study and for 3 months after the study ends; must have a negative serum pregnancy test within 7 days prior to study enrollment; and must not be breastfeeding. Male participants must agree to use effective contraception during the study and for 3 months after the study ends.
- Additional Criteria for Participants with hepatic impairment Only:
Key exclusion criteria (21 listed)
- Drug-induced liver injury.
- Any of the following conditions: history of liver transplantation; presence of acute or worsening liver injury due to any cause; liver failure; concurrent Grade 3/4 hepatic encephalopathy; active hepatocellular carcinoma lesions; severe esophageal or gastric varices or history of rupture and bleeding; severe/late-stage ascites or pleural effusion requiring paracentesis/thoracentesis and albumin supplementation; hepatorenal syndrome; or any other condition deemed by the investigator as unsuitable for study participation.
- History of cholestasis, biliary tract infection, or other diseases affecting bile excretion within 3 months prior to screening.
- Esophageal or gastric variceal bleeding due to portal hypertension within 3 months prior to screening, or history of portosystemic shunt surgery (including Transjugular Intrahepatic Portosystemic Shunt - TIPS) within 6 months prior to screening.
- History of significant allergy or intolerance to any drug, food, or other substance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olverembatinib 20mgorally after meal, single dose | Drug | Group 1: 6-8 participants with mild hepatic impairment., Group 2: 6-8 participants with normal hepatic function matched to Group 1, Group 3: 6-8 participants with moderate hepatic impairment, Group 4: 6-8 participants with normal hepatic function matched to Group 3, Group 5: 6-8 participants with severe hepatic impairment, Group 6: 6-8 participants with normal hepatic function matched to Group 5 |
Primary outcome
Maximum observed plasma concentration C(max)
Time frame: Day 1 to Day 9
The C(max) of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
Time to C(max) [ t(max) ]
Time frame: Day 1 to Day 9
The t(max) of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
Apparent terminal elimination half-life (t½)
Time frame: Day 1 to Day 9
The t½ of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
Area under the concentration-time curve from time zero to last time of quantifiable concentration [AUC(last)]
Time frame: Day 1 to Day 9
The AUC(last) of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
Area under the concentration-time curve from time zero to 192h AUC(0-192h)
Time frame: Day 1 to Day 9
The AUC(0-192h) of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
Apparent Clearance (CL/F)
Time frame: Day 1 to Day 9
The CL/F of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
Apparent Volume of distribution (Vz/F)
Time frame: Day 1 to Day 9
The Vz/F of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
Unbound Fraction (fu)
Time frame: Day 1 to Day 9
The unbound fraction (fu) of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
1 secondary outcome
Safety evaluation endpoints
Time frame: Day1-Day21
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
Related trials for Pharmacokinetic
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
CRC
Not yet recruitingPhase 1
Pharmacokinetics, Safety and Tolerability of Single Sequential and Multiple Intravenous Infusions of Ulinastatin for Injection in Healthy Chinese Participants
Healthy Participants, Ulinastatin
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiang Xu, M.D. contact
Liyan Miao, M.D.,Ph.D. principal investigator
M.D.,Ph.D.
Weifeng Zhao, M.D.,Ph.D. principal investigator
The First Affiliated Hospital of Suzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Olverembatinib 20mg in people with Pharmacokinetic and Olverembatinib, run by Ascentage Pharma Group Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yifan Zhai, M.D., Ph.D. (18998334688, yzhai@ascentagepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma concentration C(max) (time frame: Day 1 to Day 9). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.