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| Name | Class |
|---|---|
| Guangzhou Healthquest Pharma Co., Ltd | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: 6-8 participants with mild hepatic impairment. | Experimental |
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| Group 2: 6-8 participants with normal hepatic function matched to Group 1 | Experimental |
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| Group 3: 6-8 participants with moderate hepatic impairment | Experimental |
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| Group 4: 6-8 participants with normal hepatic function matched to Group 3 | Experimental |
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| Group 5: 6-8 participants with severe hepatic impairment | Experimental |
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| Group 6: 6-8 participants with normal hepatic function matched to Group 5 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olverembatinib 20mg | Drug | orally after meal, single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. | Day 1 to Day 9 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day1-Day21 |
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Inclusion Criteria:
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.
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yifan Zhai, M.D., Ph.D. | Contact | 18998334688 | yzhai@ascentagepharma.com | |
| Xiang Xu, M.D. | Contact | Xiang.Xu@ascentage.com |
| Name | Affiliation | Role |
|---|---|---|
| Liyan Miao, M.D.,Ph.D. | M.D.,Ph.D. | Principal Investigator |
| Weifeng Zhao, M.D.,Ph.D. | The First Affiliated Hospital of Suzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Suzhou Medical University | Recruiting | Suzhou | Jiangsu | 215006 | China |
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| ID | Term |
|---|---|
| C579813 | olverembatinib |
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| 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. | 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. | Day 1 to Day 9 |