Pharmacokinetics and Safety of SHR0302 in Patients With Hepatic Impairment

  • STATUS
    Recruiting
  • participants needed
    24
  • sponsor
    Jiangsu HengRui Medicine Co., Ltd.
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Updated on 16 February 2024
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body mass index
liver disease
hepatic impairment
moderate hepatic impairment
moderate hepatic insufficiency

Summary

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

Details
Condition Hepatic Impairment
Age 18years - 65years
Treatment SHR0302
Clinical Study IdentifierNCT04293029
SponsorJiangsu HengRui Medicine Co., Ltd.
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

All subjects
Signing the informed consent forms
years to 65 years (inclusive)
Body mass index should be between 18 and 30 kg/m2 (inclusive)
No medication was used before screeningor stable medication for 4 weeks
Normal liver function
Clinical laboratory tests during the screening period were normalor 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 injuryacute liver injuryliver transplantation history
Subjects with hepatic failure,or severe complications caused by Hepatocirrhosis
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