Lung Cancer
Conditions
Brief summary
Evaluation of the Pharmacokinetics and Safety of Anecatibin Fumarate Capsules in Subjects with Impaired Liver Function versus Normal Liver Function
Interventions
DRUGAnecatibin Fumarate Capsules
Anecatibin fumarate capsule is a prodrug that can be rapidly hydrolyzed into crizotinib in vivo to exert pharmacodynamic effects. Crizotinib is a tyrosine kinase receptor inhibitor, including Anaplastic lymphoma kinase (ALK), hepatocyte growth factor receptor Hepatocyte Growth Factor Receptor(HGFR, c-Met), ROS Proto-Oncogene 1, Receptor Tyrosine Kinase (ROS1, c-cos), and Recepteur d'Origine Nantais (RON).
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
All subjects must meet all of the following inclusion criteria: * Provide signed informed consent prior to trial participation and have a full understanding of the trial content, procedures, and potential adverse reactions; * Be male or female subjects aged 18 to 65 years (inclusive); * Weigh at least 50 kg for males and at least 45 kg for females. Body Mass Index (BMI = weight (kg) / height² (m²)) within the range of 18 to 30 kg/m² (inclusive of boundary values); * Subjects and their partners agree to voluntarily adopt effective contraceptive measures from screening until 6 months after the last dose; * Subjects are able to communicate well with the investigators and can complete the study according to the study protocol. Subjects with normal liver function must also meet the following inclusion criteria: * Negative test results for Hepatitis B surface antigen and Hepatitis C antibody; * Normal liver function test results or abnormal results without clinical significance; * Matched with the hepatic impairment group in terms of male-to-female ratio (±1 subject per gender), mean age (±10 years), and mean body weight (±10 kg). Subjects with hepatic impairment must meet the following inclusion criteria: * Have a history of or be diagnosed at screening with primary liver disease, including but not limited to: Hepatitis B, Hepatitis C, non-alcoholic fatty liver disease, alcoholic liver disease, etc.; * Hepatic impairment is caused by a previous primary liver disease (diagnosed at least 2 weeks prior to screening; excluding oncology patients) and is classified as Child-Pugh Class A or B; * Liver function is stable within 2 weeks prior to taking the study drug, as determined by the investigator; * No medication for liver disease within 4 weeks prior to screening, or on a stable medication regimen for existing underlying conditions.
Exclusion criteria
All subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine the Cmax | The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 days | To determine the Cmax of TQ-B3101 and its benzyloxypyridine metabolites. |
| To determine the Area Under the Curve (AUC) 0-t | The period extends from the date of the first dose to the completion of the end of treatment (EOT) visit, totaling 5 days | To determine the AUC 0-t of TQ-B3101 and its benzyloxypyridine metabolites. |
| To determine the AUC 0-∞ | The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 days | To determine the AUC 0-∞ of TQ-B3101 and its benzyloxypyridine metabolites. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax of TQ-B3101 and its benzyloxy pyridine metabolite | The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 days | Obtain the Tmax of TQ-B3101 and its benzyloxy pyridine metabolite. |
| t1/2 of TQ-B3101 and its benzyloxy pyridine metabolite | The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 days | Obtain the t1/2 of TQ-B3101 and its benzyloxy pyridine metabolite. |
| Vz/F of TQ-B3101 and its benzyloxy pyridine metabolite | The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 days | Obtain the Vz/F of TQ-B3101 and its benzyloxy pyridine metabolite |
| Apparent Clearance (CLz/F) of TQ-B3101 and its benzyloxy pyridine metabolite | The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 days | Obtain the CLz/F of TQ-B3101 and its benzyloxy pyridine metabolite. |
| Numbers of subjects with adverse events | The period extends from the first dose date to the completion of the safety follow-up, not to exceed 90 days | Numbers of subjects with adverse events, including adverse events, clinical symptoms, physical examinations, vital signs (blood pressure, pulse, and body temperature), laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function), and 12-lead electrocardiogram (ECG). |
Countries
China
Contacts
CONTACTYu Cao, Doctor
Outcome results
None listed