Pharmacokinetics and Safety of SHR0302 in Patients With Hepatic Impairment

Hepatic Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04293029
• Other study ID #: SHR0302-106
• Status: Completed
• Phase: Phase 1
• Start date: May 20, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: February 2020
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 30, 2020
• Est. primary completion date: December 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• SHR0302
SHR0302

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Area under the plasma concentration versus time curve from single dosing time extrapolated to infinity(AUC0-8)	Area under the plasma concentration versus time curve from single dosing time extrapolated to infinity(AUC0-8) will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients	72 hours after dosing
Primary	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	Adverse events	Number of Participants With Adverse Events and Serious Adverse Events	72 hours after dosing