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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
SHR0302
The First Affiliated Hospital of Jilin University
Changchun, Jilin, China
Peak Plasma Concentration (Cmax)
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
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
Time frame: 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
Time frame: 72 hours after dosing
Adverse events
Number of Participants With Adverse Events and Serious Adverse Events
Time frame: 72 hours after dosing
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