Pharmacokinetics and Safety of SHR0302 in Patients With Hepatic Impairment

Phase 1

Completed

• Conditions: Hepatic Impairment
• Interventions: Drug: SHR0302

• Registration Number: NCT04293029
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-28
• Study First Submitted QC: 2020-03-02
• Study First Posted: 2020-03-03
• Study Start: 2020-05-20
• Primary Completion: 2020-12-27
• Study Completion: 2020-12-30
• Last Update Submitted: 2021-10-13
• Last Update Posted: 2021-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal liver function	SHR0302	Patients will receive single dose of SHR0302
Moderate Hepatic Impairment	SHR0302	Patients will receive single dose of SHR0302
Mild Hepatic Impairment	SHR0302	Patients will receive single dose of SHR0302

Primary Outcome Measures

Name	Time	Method
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
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 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

Name	Time	Method
Adverse events	72 hours after dosing	Number of Participants With Adverse Events and Serious Adverse Events

Trial Locations

Locations (1)

The First Affiliated Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China