Clinical Trial of FCN-437c Capsule in Patients With Hepatic Insufficiency

Exclusion Criteria

• •Subjects with hepatic impairment will be excluded from the study if they meet any of the following criteria.
• •1. Subjects with any of the following conditions: drug induced liver injury; history of liver transplantation; cirrhotic patients with liver failure or complications such as grade 3/4 hepatic encephalopathy, ruptured varices of the fundus esophagus, or hemorrhage, which in the opinion of the investigator are inappropriate; severe/advanced peritoneal or pleural effusions requiring puncture drainage and albumin supplementation.
• •2. Diseases affecting the excretion of bile, such as biliary cirrhosis.
• •3. those with severe portal hypertension or previous portosystemic shunts, including transjugular intrahepatic portosystemic shunts.
• •4. In addition to primary diseases of the liver, have previously suffered from serious primary diseases of other important organs, including but not limited to neuropsychiatric, gastrointestinal, respiratory, urinary, endocrine, hematological, immunological, etc., which, in the judgment of the investigator, make them unsuitable for participation in this trial.
• •5. Myocardial infarction, severe/unstable colic, symptomatic congestive heart failure (NYHA class II-IV), or clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention within 6 months prior to study entry.
• •6. any other malignancy diagnosed within 5 years prior to study participation, except for radically treated early stage malignancies (carcinoma in situ or stage I tumors), such as adequately treated basal cell or squamous cell skin cancers or carcinoma in situ of the cervix.
• •7. severe infection, trauma, gastrointestinal surgery or other major surgical procedure within 4 weeks prior to screening;
• •8. have lost or donated ≥400 mL of blood or received a red blood cell transfusion within 1 month prior to screening; or have taken any clinical trial medication within 1 month prior to screening.
• •9. allergy, including a history of severe drug allergy or drug metabolism; known hypersensitivity to FCN-437C capsule or its excipients.
• •10. Regular drinkers (≥14 units of alcohol per week: 1 unit = 360 mL of beer, or 45 mL of 40% alcohol by volume, or 150 mL of wine) in the 6 months prior to screening; smokers ≥5 cigarettes per day in the 3 months prior to screening; those with a positive alcohol screen; and those who are unable to abstain from smoking and alcohol for the duration of the trial.
• •11. a history of drug use, or a history of substance abuse within the past 5 years, or a positive drug screen (except for a positive drug screen due to concomitant medication use).
• •12. HIV antibody-positive and syphilis antibody-positive patients; syphilis antibody-positive patients can be enrolled if they are negative for RPR.
• •13. pregnant or breastfeeding women.
• •14. persons who have received a live (attenuated) vaccine (other than influenza vaccine) within 14 days prior to screening or who plan to receive it during the course of the trial.
• •15. who have taken a strong or moderate inducer or strong or moderate inhibitor of CYP3A (Annex III), or prescription, over-the-counter, herbal, or dietary supplements other than medications for the treatment of hepatic impairment and other concomitant diseases within 14 days prior to administration of study drug.
• •16. ingestion of grapefruit or grapefruit-containing products, fruit juices, foods or beverages containing methylxanthines (e.g., tea, coffee, cola, chocolate, functional beverages) or alcohol within 72 hours prior to the administration of the study drug; strenuous physical activity; or any other factor that affects the absorption, distribution, metabolism, excretion, etc. of the drug.
• •17. the presence of other serious physical or mental illnesses or abnormal laboratory tests, and other factors that may increase the risk of participation in the study or interfere with the results of the study; and any other condition that, in the opinion of the investigator, makes participation in this study inappropriate.
• •1. a previous history of liver impairment, or a physical examination and laboratory tests at the time of screening suggesting the presence or potential presence of liver impairment.
• •2. Previously suffered from primary diseases of important organs, including but not limited to neuropsychiatric, cardiovascular, gastrointestinal, respiratory, urinary, endocrine, hematological, immunological, etc., which, in the judgment of the investigator, are not suitable for participation in this trial;
• •3. severe infection, trauma, gastrointestinal surgery or other major surgical procedure within 4 weeks prior to screening;
• •4. have lost or donated ≥400 mL of blood or received a blood transfusion within 3 months prior to screening; or have taken any clinical trial medication.
• •5. allergy, including a history of severe drug allergy or drug metabolism; known hypersensitivity to FCN-437c capsule or its excipients.
• •6. Regular alcohol drinkers in the 6 months prior to screening (≥14 units of alcohol per week: 1 unit=beer 360 mL, or 45 mL of 40% alcohol by volume spirits, or 150 mL of wine); smoked ≥5 cigarettes per day in the 3 months prior to screening; screened positive for alcohol; and were unable to abstain from smoking and alcohol during the trial.
• •7. a history of drug abuse, or a history of substance abuse within the past five years, or a positive drug screen.
• •8. Hepatitis B surface antigen (HBsAg) positive, Hepatitis C (HCV) antibody positive, HIV antibody positive, Syphilis antibody positive.
• •9. QTc intervals (QTcF) corrected by Fridericia's criteria \>470 msec in men and \>480 msec in women.
• •10. pregnant or breastfeeding women.
• •11. persons who have received a live attenuated vaccine within 14 days prior to screening or who plan to receive a vaccine during the course of the trial (except for influenza vaccine).
• •12. have taken an inducer or inhibitor of CYP3A (Annex III), or any prescription, over-the-counter, herbal, or dietary supplement within 14 days prior to administration of study drug.
• •13. ingestion of grapefruit or grapefruit-containing products, fruit juices, foods or beverages containing methylxanthines (e.g., tea, coffee, cola, chocolate, functional beverages) or alcohol within 72 hours prior to the administration of the study drug; strenuous physical activity; or any other factor that affects the absorption, distribution, metabolism, excretion, etc. of the drug.
• •14. the presence of other serious physical or mental illnesses or abnormal laboratory tests, and other factors that may increase the risk of participation in the study or interfere with the results of the study; and any other condition that, in the opinion of the investigator, makes participation in the study unsuitable.