Hepatic Impairment
Conditions
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.
Interventions
DRUGSHR4640
orally SHR4640
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) | 72 hours after dosing | Peak Plasma Concentration (Cmax) will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients |
| Area under the plasma concentration versus time curve from single dosing time extrapolated to infinity (AUC0-∞) | 72 hours after dosing | 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 |
Countries
China
Outcome results
None listed