Pharmacokinetics and Safety of SHR0302 in Patients With Hepatic Impairment
NCT ID: NCT04293029
Last Updated: 2021-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2020-05-20
2020-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Normal liver function
Patients will receive single dose of SHR0302
SHR0302
SHR0302
Mild Hepatic Impairment
Patients will receive single dose of SHR0302
SHR0302
SHR0302
Moderate Hepatic Impairment
Patients will receive single dose of SHR0302
SHR0302
SHR0302
Interventions
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SHR0302
SHR0302
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Jilin University
Changchun, Jilin, China
Countries
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Other Identifiers
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SHR0302-106
Identifier Type: -
Identifier Source: org_study_id