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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Hepatic Impairment

Intervention / Treatment
-----------------
* Drug: SHR4640


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal liver function<br>Patients will receive single dose of SHR4640 | Drug: SHR4640<br>* orally SHR4640<br>|
| Experimental: Mild Hepatic Impairment<br>Patients will receive single dose of SHR4640 | Drug: SHR4640<br>* orally SHR4640<br>|
| Experimental: Moderate Hepatic Impairment<br>Patients will receive single dose of SHR4640 | Drug: SHR4640<br>* orally SHR4640<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) | Peak Plasma Concentration (Cmax) will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients | 72 hours after dosing | 
| Area under the plasma concentration versus time curve from single dosing time extrapolated to infinity (AUC0-∞) | Area under the plasma concentration versus time curve from single dosing time extrapolated to infinity (AUC0-∞) will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients | 72 hours after dosing |