Status:
UNKNOWN
Pharmacokinetics, Pharmacodynamics and Safety of SHR4640 in Patients With Hepatic Impairment
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Hepatic Impairment
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- \-
- 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
- \-
- 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.
Key Trial Info
Start Date :
August 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04305392
Start Date
August 4 2020
End Date
December 1 2022
Last Update
August 10 2022
Active Locations (1)
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1
Meixia Wang
Beijing, Beijing Municipality, China, 100069