Status:
COMPLETED
A Clinical Study to Access the Pharmacokinetics of HMS5552 in Hepatic Impaired Subjects and Healthy Volunteers
Lead Sponsor:
Hua Medicine Limited
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The objectives of this study is to access the pharmacokinetics and safety of HMS5552 in single dose in mild and moderate hepatic impaired subjects and matched healthy adult subjects.
Detailed Description
This is an open-label and paralleled study with single oral dose of HMS5552 given to hepatic impaired subjects and matched healthy volunteers. The primary objective is to access the pharmacokinetic p...
Eligibility Criteria
Inclusion
- For hepatic impaired subjects:
- Male and female subjects between ages of 18 and 65 years, no less than 3 subjects in each gender.
- Body weight≥50kg for male and ≥45kg for female； BMI: 18.5\~30 kg/m2
- ALT\>2×normal upper limit (ULN), or TBiL\>1.5×ULN, or diagnosed cirrhosis. The related clinical manifestations have been stable for 4-12 weeks, and Child-Pugh score is in grade A or B:
- A= mild liver damage (Group A): Child-Pugh 5-6; B= moderate liver damage (Group B): Child-Pugh 7-9;
- Willing to sign the informed consent form (ICF) and take reliable contraceptive measures within 6 months after taking the last dose of study drug;
- Willing to adhere to the protocol requirement.
- For healthy volunteers:
- Male and female subjects between ages of 18 and 65 years, no less than 3 subjects in each gender;
- Body weight≥50kg for male and ≥45kg for female； BMI: 18.5\~30 kg/m2;
- Gender, age (±5 years) and BMI (±15%) matched with corresponding subject in hepatic impaired group;
- Normal physical conditions, vital signs,12 lead ECG and laboratory recording;
- Willing to sign the informed consent form (ICF) and take reliable contraceptive measures within 6 months after taking the last dose of study drug;
- Willing to adhere to the protocol requirement.
Exclusion
- Subjects with impaired hepatic function cannot be enrolled if they meet one of the following criteria:
- Liver cancer, liver transplantation, liver failure, autoimmune liver disease, biliary cirrhosis, or drug-induced liver damage;
- History of allergy;
- Investigators adjudicate subjects have surgery that may affect drug absorption, distribution, metabolism or excretion;
- In addition to diseases and complications of impaired hepatic function, investigator adjudicate subjects have clinically meaningful or unstable diseases or complications of central nervous system, cardiovascular system, digestive system, endocrine system, respiratory system, urinary system, blood system, mental disease, or malignant tumor, etc;
- Abnormal of ECG performance or laboratory recording during screening;
- Family history of QT prolongation syndrome;
- History of hepatic encephalopathy or hepatic coma within 6 months before screening;
- More than 5 cigarettes per day within 3 months before screening;
- Alcohol addicts;
- History of drug abuse
- Healthy subjects cannot be enrolled if they meet one of the following criteria:
- History of allergy;
- Investigators adjudicate subjects have surgery that may affect drug absorption, distribution, metabolism or excretion;
- Investigator adjudicate subjects have clinically meaningful or unstable diseases or complications of central nervous system, cardiovascular system, digestive system, endocrine system, respiratory system, urinary system, blood system, mental disease, or malignant tumor, etc;
- Abnormal of ECG performance or laboratory recording during screening;
- Family history of QT prolongation syndrome;
- Severe infection, severe trauma or major surgery judged by investigator within 3 months before screening;
- More than 5 cigarettes per day within 3 months before screening;
- Alcohol addicts;
- History of drug abuse
Key Trial Info
Start Date :
February 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 3 2020
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04426708
Start Date
February 18 2019
End Date
July 3 2020
Last Update
November 29 2022
Active Locations (1)
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1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610000