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

Pharmacokinetics, Pharmacodynamics and Safety of SHR4640 in Patients With Hepatic Impairment (Multicenter, Single Dose, Parallel, Open)

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.

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:

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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.