| Eligibility |
Inclusion Criteria:
-
Participants with mild to moderate liver impairment must meet all of the following criteria
to enter the study:
- The informed consent is signed before the trial, and the content, process and possible
adverse reactions are fully understood; Be able to complete the study according to the
requirements of the test scheme;
- Both male and female, subjects aged 18 to 65 years (including both ends) on the date
of signing informed consent;
- The body weight of male subjects is =50 kg, while female subjects is =45 kg. Body mass
index (BMI) is in the range of 18.5 kg/m2-30 kg/m2;
- Chronic stable primary liver disease is necessary for patients with liver impairment,
then patients with Grade-A/mild liver impairment (Child-Pugh score: 5-6) and
Grade-B/moderate liver impairment (Child-Pugh score: 7-6) are assessed according to
Child-Pugh classification;
- Provide documentary evidence of confirmed liver impairment;
- Patients who have stable medication regimen for liver impairment, complications and
other concomitant diseases within at least 28 days before taking the experimental
drug, and the medication does not need to be adjusted (including drug type, dosage or
frequency) during the clinical trials; or those who do not use the drug;
- The function of vital organs meets the following criteria: Absolute neutrophil count
(ANC) = 1.0 × 109 / L (1000 / mm3); Platelet = 75.0 × 109 / L (75000 / mm3);
Hemoglobin (Hgb) = 9.0 g / dL (90g / L); ALT and AST = 5ULN; Creatinine clearance rate
(CLcr) = 60 mL / min; The corrected QTc interval (QTcF) = 450 msec (male), = 470 msec
(female);
- In addition to liver impairment and complications, the investigator judged good
condition according to the history inquiry, vital signs, physical examination, routine
laboratory examination, 12-lead ECG, EEG, etc., and there was no other clinically
significant abnormality;
- No family planning during the trial and within 6 months after the last administration
of the trial drug, and voluntarily take effective contraceptive measures; Serum
pregnancy test must be negative within 7 days before the experimental drug for women
of childbearing age.
Exclusion Criteria:
-
Participants with mild to moderate liver impairment who meet any of the following criteria
will not be eligible for this study:
- Subjects had any of the following conditions: drug-induced liver injury; history of
liver transplantation; liver failure, or cirrhosis with grade 3/4 hepatic
encephalopathy, esophageal and gastric varices bleeding and other complications
considered inappropriate by researchers; severe / advanced peritoneal effusion or
pleural effusion requiring puncture drainage and albumin supplement; patients with
hepatorenal syndrome; patients with hepatorenal syndrome;
- Biliary cirrhosis, biliary obstruction, cholestatic liver disease and other diseases
that affect bile excretion;
- Patients with severe portal hypertension or previous portosystemic shunt, including
transjugular intrahepatic portosystemic shunt;
- In addition to primary liver diseases, those who had previously suffered from serious
primary diseases of other important organs were not suitable for the trial according
to the judgment of the researchers;
- Any of the following conditions occurred within 6 months prior to the study:
Myocardial infarction, severe / unstable angina, symptomatic congestive heart failure
(NYHA class II-IV), supraventricular or ventricular arrhythmias;
- History of malignant tumor in the past 5 years;
- Patients with severe infection, trauma, gastrointestinal surgery or other major
surgical operations within 4 weeks before screening;
- History of drug use, or have a history of drug abuse in the past five years, or have a
positive drug screening (except those with drug screening positive due to concomitant
drug use);
- HIVAb positive, syphilisAb positive;
- Pregnant or lactating women;
- Strong inducers or inhibitors of CYP3A4, CYP2C9 or CYP2C8 were taken within 14 days
before administration of the study drug; used traditional Chinese medicine, dietary
supplements and vitamins;
- Subjects with other factors not suitable to participate in this study were considered
by the investigator.
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