Pharmacokinetics and Safety of SHR0302 in Patients With Hepatic Impairment

Study Overview
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Brief Summary
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Study to Evaluate Pharmacokinetics and Safety of SHR0302 in Patients With Mild, Moderate Hepatic Impairment and Normal Liver Function in Phase I Clinical Study

Official Title
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Pharmacokinetics and Safety of SHR0302 in Patients With Mild, Moderate Hepatic Impairment and Normal Liver Function in Phase I Clinical Study

Conditions
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Hepatic Impairment

Intervention / Treatment
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* Drug: SHR0302


Participation Criteria
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Eligibility Criteria
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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
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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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 SHR0302 | Drug: SHR0302<br>* SHR0302<br>|
| Experimental: Mild Hepatic Impairment<br>Patients will receive single dose of SHR0302 | Drug: SHR0302<br>* SHR0302<br>|
| Experimental: Moderate Hepatic Impairment<br>Patients will receive single dose of SHR0302 | Drug: SHR0302<br>* SHR0302<br>|

What is the study measuring?
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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 | 
| Area under the plasma concentration versus time curve from the last time of dosing to the last measurable concentration （AUC0-t） | Area under the plasma concentration versus time curve from the last time of dosing to the last measurable concentration （AUC0-t） will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients | 72 hours after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Number of Participants With Adverse Events and Serious Adverse Events | 72 hours after dosing |