Back to resultsPharmacokinetics and Safety of SHR0302 in Patients With Hepatic Impairment
Primary Purpose
Hepatic Impairment
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR0302
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Impairment
Eligibility 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.
Sites / Locations
- The First Affiliated Hospital of Jilin University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Normal liver function
Mild Hepatic Impairment
Moderate Hepatic Impairment
Arm Description
Patients will receive single dose of SHR0302
Patients will receive single dose of SHR0302
Patients will receive single dose of SHR0302
Outcomes
Primary Outcome Measures
Peak Plasma Concentration (Cmax)
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-∞）
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）
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
Number of Participants With Adverse Events and Serious Adverse Events
Full Information
NCT ID
NCT04293029
First Posted
February 28, 2020
Last Updated
October 13, 2021
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04293029
Brief Title
Pharmacokinetics and Safety of SHR0302 in Patients With Hepatic Impairment
Official Title
Pharmacokinetics and Safety of SHR0302 in Patients With Mild, Moderate Hepatic Impairment and Normal Liver Function in Phase I Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 20, 2020 (Actual)
Primary Completion Date
December 27, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal liver function
Arm Type
Experimental
Arm Description
Patients will receive single dose of SHR0302
Arm Title
Mild Hepatic Impairment
Arm Type
Experimental
Arm Description
Patients will receive single dose of SHR0302
Arm Title
Moderate Hepatic Impairment
Arm Type
Experimental
Arm Description
Patients will receive single dose of SHR0302
Intervention Type
Drug
Intervention Name(s)
SHR0302
Intervention Description
SHR0302
Primary Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax)
Description
Peak Plasma Concentration (Cmax) will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients
Time Frame
72 hours after dosing
Title
Area under the plasma concentration versus time curve from single dosing time extrapolated to infinity（AUC0-∞）
Description
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
Time Frame
72 hours after dosing
Title
Area under the plasma concentration versus time curve from the last time of dosing to the last measurable concentration （AUC0-t）
Description
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
Time Frame
72 hours after dosing
Secondary Outcome Measure Information:
Title
Adverse events
Description
Number of Participants With Adverse Events and Serious Adverse Events
Time Frame
72 hours after dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
The First Affiliated Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetics and Safety of SHR0302 in Patients With Hepatic Impairment
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