Pharmacokinetics, Pharmacodynamics and Safety of SHR4640 in Patients With Hepatic Impairment

• Status: Enrolling by invitation
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Study to evaluate pharmacokinetics, pharmacodynamics and safety of SHR4640 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:

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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.