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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04293029

Enrollment

Registered

2020-03-03

Start date

2020-05-20

Completion date

2020-12-30

Last updated

2021-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Impairment

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

Interventions

DRUGSHR0302

SHR0302

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 4, 2026