This multi-center, open-label, parallel-controlled, single-dose Phase 1 study is being conducted to directly characterize the pharmacokinetic (PK) profiles and safety of Jaktinib following administration of a single oral dose in subjects with varying degrees of hepatic impairment compared to healthy matched control subjects with normal hepatic function(matched by age, weight, and sex).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
A single oral dose of 100 mg Jaktinib Hydrochloride Tablets will be administered.
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]of Jaktinib and its metabolites(ZG0244 and ZG0245)
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Time frame: From day 1 to day 3
Maximum Observed Plasma Concentration (Cmax) of Jaktinib and its metabolites(ZG0244 and ZG0245)
To evaluate Maximum Observed Plasma Concentration (Cmax) of Jaktinib and its metabolites(ZG0244 and ZG0245)
Time frame: From day 1 to day 3
Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of Jaktinib and its metabolites(ZG0244 and ZG0245)
The AUC (0-infinity) is the area under the plasma Jaktinib and its metabolites(ZG0244 and ZG0245)concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z)
Time frame: From day 1 to day 3
Number of Participants with Adverse Events (AEs) and Serious AEs
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Screening up to follow-up (7 days after dose administration)
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