Status:
COMPLETED
Pharmacokinetics and Safety of SHR0302 in Patients With Hepatic Impairment
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Hepatic Impairment
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Study to Evaluate Pharmacokinetics and Safety of SHR0302 in Patients With Mild, Moderate Hepatic Impairment and Normal Liver Function in Phase I Clinical Study
Eligibility Criteria
Inclusion
- All subjects:：
- Signing the informed consent forms；
- 18 years to 65 years (inclusive)；
- Body mass index should be between 18 and 30 kg/m2 (inclusive)；
- No medication was used before screening，or stable medication for 4 weeks.
- Normal liver function：
- Clinical laboratory tests during the screening period were normal，or the abnormality has no clinical significance.
- Hepatic impaired subjects:
- Child-Pugh Classification score clinically determined as mild or moderate hepatic impairment.
- Liver damage due to primary liver disease.
Exclusion
- All subjects:
- Subject known or suspected of being sensitive to the study drugs or its ingredient；
- Normal liver function：
- Previous history of liver function impairment, or physical examination and laboratory examination at screening indicated the presence or possibility of liver function impairment.
- Hepatitis B surface antigen (HBsAg) positive or Anti-hepatitis C virus (HCV) antibody or hepatitis C core antigen positive within 3 months prior to administration.
- Hepatic impaired subjects:
- Suspected or diagnosed as liver cancer or with other malignant tumors;
- Drug induced liver injury，acute liver injury，liver transplantation history.
- Subjects with hepatic failure,or severe complications caused by Hepatocirrhosis.
Key Trial Info
Start Date :
May 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04293029
Start Date
May 20 2020
End Date
December 30 2020
Last Update
October 14 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Affiliated Hospital of Jilin University
Changchun, Jilin, China