The objectives of this study is to access the pharmacokinetics and safety of HMS5552 in single dose in mild and moderate hepatic impaired subjects and matched healthy adult subjects.
This is an open-label and paralleled study with single oral dose of HMS5552 given to hepatic impaired subjects and matched healthy volunteers. The primary objective is to access the pharmacokinetic profiles of HMS5552 in 25 mg dose in hepatic impaired subjects and (gender, age and BMI) matched healthy adult subjects. The secondary objective is to characterize the safety profiles of HMS5552 in single dose in hepatic impaired subjects. The subjects include mild hepatic impaired subjects (A group), moderate hepatic impaired subjects (B group), and healthy subjects (C Group) matched with hepatic impaired subjects in gender, age and BMI. The number of subjects in each group was no less than 8, and no less than 3 subjects in each gender.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
single dose of HMS5552 25mg
West China Hospital of Sichuan University
Chengdu, Sichuan, China
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of Cmax;
Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.
Time frame: Up to 72 hours post-dose
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of AUClast;
Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.
Time frame: Up to 72 hours post-dose
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of AUCinf;
Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.
Time frame: Up to 72 hours post-dose
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of Cmax,u
Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.
Time frame: Up to 72 hours post-dose
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of AUClast,u
Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.
Time frame: Up to 72 hours post-dose
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of AUCinf,u
Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.
Time frame: Up to 72 hours post-dose
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The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of Tmax ;
Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.
Time frame: Up to 72 hours post-dose
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of T1/2;
Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.
Time frame: Up to 72 hours post-dose
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of CL/F;
Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.
Time frame: Up to 72 hours post-dose
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of Vz/F;
Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.
Time frame: Up to 72 hours post-dose
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of fu;
Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.
Time frame: Up to 72 hours post-dose