Pharmacokinetics and Safety of SHR0302 in Patients With Hepatic Impairment
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Normal liver function Patients will receive single dose of SHR0302 |
Drug: SHR0302
SHR0302
|
| Experimental: Mild Hepatic Impairment Patients will receive single dose of SHR0302 |
Drug: SHR0302
SHR0302
|
| Experimental: Moderate Hepatic Impairment Patients will receive single dose of SHR0302 |
Drug: SHR0302
SHR0302
|
Outcome Measures
Primary Outcome Measures
- 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
- Area under the plasma concentration versus time curve from the last time of dosing to the last measurable concentration （AUC0-t） [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） will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients
Secondary Outcome Measures
- Adverse events [72 hours after dosing]
Number of Participants With Adverse Events and Serious Adverse Events
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of Jilin University | Changchun | Jilin | China |
Sponsors and Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHR0302-106