Pharmacokinetics and Safety of SHR0302 in Patients With Hepatic Impairment

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

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

Study Overview

• Status: Completed
• Conditions: Hepatic Impairment
• Intervention / Treatment: Drug: SHR0302

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China
      • The first Affiliated Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration (Cmax)	Peak Plasma Concentration (Cmax) will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients	72 hours after dosing
Area under the plasma concentration versus time curve from single dosing time extrapolated to infinity（AUC0-∞）	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	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）	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	72 hours after dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Number of Participants With Adverse Events and Serious Adverse Events	72 hours after dosing

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Actual): December 27, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: February 28, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Actual): October 14, 2021
• Last Update Submitted That Met QC Criteria: October 13, 2021
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: SHR0302-106

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No