Pharmacokinetics and Safety of SHR0302 in Patients With Hepatic Impairment

• Status: Completed
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

Inclusion Criteria:

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 Criteria:

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.