T2DM
Conditions
Interventions
Healthy subjects & subjects with mild liver injury & moderate Liver damage subjects:drug
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Subjects with liver function damage are required to meet all of the following selection criteria in order to qualify for this study: 1. Aged 18-65 years (including 18 and 65 years of age), male and female, and the number of single-sex subjects per group is not less than 3 cases; 2. Weight: Male 50 kg or female ?45 kg;bmi within the 18.5~30.0 kg/m2 range (including 18.5 and 30.0 kg/m2); 3. Subjects with liver function impairment diagnosed on the basis of clinical evidence such as the subject's medical history, physical examination, imaging examination, laboratory examination [need to meet alanine aminotransferase (ALT) > 2x normal value upper limit (ULN) or total bilirubin (TBiL) > 1.5xULN or diagnosed with cirrhosis], The relevant clinical manifestations have been stable for 4-12 weeks, and the Child-pugh rating is divided into a or B levels: 1) Class A = mild liver function damage (Group A): Child-pugh 5 to 6 points; 2) Class B = moderate liver function damage (Group B): Child-pugh 7 to 9 points; 4. Willing to take reliable contraceptive measures from the time of signing the informed consent (ICF) to the last 6 months after taking the research drug; 5. Fully understand the purpose and requirements of this study, voluntarily participate in clinical research and sign written ICF, can complete the whole research process according to the research requirements; Healthy subjects are required to meet all of the following selection criteria in order to qualify for this study: 1. Age 18-65 years (including 18 and 65 years of age), male and female, and the number of single-sex subjects per group is not less than 3 cases; 2. Weight: Male ?50 kg or female ?45 kg;bmi within the 18.5~30.0 kg/m2 range (including 18.5 and 30.0 kg/m2); 3. Match the group of subjects with liver function impairment on the ratio of men to women, average age (± 5 years) and average BMI (±15%); 4. Physical examination, Vital signs examination, 12-guided electrocardiogram (ECG) examination, laboratory examination indicators are normal or to the extent that the researchers consider acceptable; 5. Willing to adopt reliable contraceptive methods within 6 months of the signing of the ICF and the last time the study drug was taken; 6. Fully understand the purpose and requirements of this study, voluntarily participate in this clinical study and sign a written ICF, can complete the entire research process according to the research requirements.
Exclusion criteria
Exclusion criteria: Liver function damage subjects could not be included in the group if they met any of the following criteria: 1. Liver cancer, liver transplantation, liver failure, autoimmune liver disease, biliary cirrhosis or drug liver function damage; 2. Have a variety of drug allergy history, allergic disorders or allergic physique; 3. The researchers determined that the subjects had undergone operations that might affect the study of drug absorption, distribution, metabolism or excretion (such as gastric intestinal surgery, etc.), or that, in addition to liver dysfunction and its complications, there were states that might affect the study of drug absorption, distribution, metabolism or excretion (such as gastric outlet obstruction); 4. In addition to the disease of liver function damage and complications of liver function damage, the researchers judged the clinical significance or instability of the central nervous system, cardiovascular system, digestive system, endocrine system, respiratory systems, urinary systems, blood system, mental illness, malignant tumor and other diseases or history of the person; 5. When screening, the researchers found that there were abnormalities in laboratory examination results that were not suitable for this study (except for laboratory abnormalities caused by diseases of liver dysfunction or complications of liver dysfunction) or abnormal ECG manifestations; 6. qt prolongation syndrome or family history is known; 7. A person with a history of hepatic brain or a liver coma occurred within 6 months before screening; 8. The subjects smoked an average of =5 or equivalent of tobacco per day for the 3 months preceding the screening; 9. Alcoholic addicts, defined as drinking at least 2 times a day or at least 14 times a week; or keen on alcoholics, defined as drinking at least 5 or more times per 2 hours (1 alcohol consumption is defined as wine ml, beer ml or liquor ml); 10. Those who tested positive for urinary drug abuse when they had a history of drug abuse or screening; 11. Clinical researchers who have participated in other drugs during the first 3 months of screening; 12. Persons who had donated blood or lost blood =400 ml in the first 3 months of screening; 13. Persons with severe infection, severe trauma or surgical surgery, as determined by the researchers, within the first 3 months of screening; 14. Have been vaccinated during the first 4 weeks of screening, or have used any prescription or Chinese herbal medicine other than drugs for the treatment of liver dysfunction and its complications; 15. Symptoms, signs or laboratory tests during the first 4 weeks of screening indicate rapid deterioration of liver function, such as moderate or above ascites, digestive tract hemorrhage, liver function related indicators [including ALT, aspartic acid aminotransferase (AST), Tbil and prothrombin time, etc.] The increase of two test results was greater than 50%. 16. A drug used to treat liver dysfunction and its complications, adjusted or required to adjust the type, dose or frequency of the drug during the first 4 weeks of screening or within 5 half-lives of the drug (whichever is older) until the end of the study; 17. Drugs used to treat liver dysfunction and its complications, in the first 4 weeks of screening or within 5 half-lives of the drug (whichever is older), have inhibitors or inducers involving cytochrome P450 3a4 enzyme (CYP3A4) or p-glycoprotein (P-GP); 18. Filter.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK; | — |
Countries
China
Contacts
Public ContactJia Miao
West China Hospital, Sichuan University
Outcome results
None listed