Evaluation of the Pharmacokinetics and Safety of Anecatibin Fumarate Capsules in Subjects with Impaired Liver Function versus Normal Liver Function
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;
Suffering from primary diseases of major organs, including but not limited to gastrointestinal, respiratory, renal, neurological, hematological, endocrine, oncological, immune, psychiatric, or cardiovascular diseases, as determined by the Investigator to be unsuitable for participation in this trial (except for hepatic impairment patients regarding their primary liver disease and complications of hepatic impairment);
Physical examination, vital signs, or clinical laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function) show abnormalities of clinical significance, as determined by the Investigator to be unsuitable for participation in this trial (except for hepatic impairment patients regarding their primary liver disease and complications of hepatic impairment);
Participated in any drug clinical trial and used any investigational drug within 3 months prior to screening;
Tested positive for HIV or syphilis screening;
Single group
Anecatibin Fumarate Capsules
DrugAnecatibin 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).
To determine the Cmax
To determine the Cmax of TQ-B3101 and its benzyloxypyridine metabolites.
To determine the Area Under the Curve (AUC) 0-t
To determine the AUC 0-t of TQ-B3101 and its benzyloxypyridine metabolites.
To determine the AUC 0-∞
To determine the AUC 0-∞ of TQ-B3101 and its benzyloxypyridine metabolites.
Tmax of TQ-B3101 and its benzyloxy pyridine metabolite
Obtain the Tmax of TQ-B3101 and its benzyloxy pyridine metabolite.
t1/2 of TQ-B3101 and its benzyloxy pyridine metabolite
Obtain the t1/2 of TQ-B3101 and its benzyloxy pyridine metabolite.
Vz/F of TQ-B3101 and its benzyloxy pyridine metabolite
Obtain the Vz/F of TQ-B3101 and its benzyloxy pyridine metabolite
Apparent Clearance (CLz/F) of TQ-B3101 and its benzyloxy pyridine metabolite
Obtain the CLz/F of TQ-B3101 and its benzyloxy pyridine metabolite.
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