The objectives of this study is to access the pharmacokinetics and safety of HMS5552 in single dose in renal impaired subjects and matched healthy adult subjects.
This is an open-label and paralleled study with single oral dose of HMS5552 given to renal impaired subjects and body index matched healthy volunteers. The primary objective is to access the pharmacokinetic profiles of HMS5552 in 25 mg dose in renal 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 renal impaired subjects. The subjects include ESRD subjects without dialysis (P1 group), severe (P2 group), moderate (P3 group), mild (P4 group), and healthy subjects (H Group) matched with renal impairment subjects in gender, age and BMI. The number of subjects in each group was 6-8. The study is divided into two parts: * Part 1: ESRD subjects without dialysis and matched healthy subjects (P1 and H groups; n = 8 for each group); * Part 2: subjects with severe, moderate and mild renal impairment (P2, P3 and P4 groups; n = 6-8 in each group). The study initiates from Part 1. The data will be evaluated at the end of Part 1 as the medium term. Compared with the matched healthy subjects, if the mean AUC of HMS5552 (either AUClast or AUCinf) increased by ≥ 100% in ESRD subjects without dialysis, which means Part 2 will need to be conducted. The process of Part 2 is the same as that of Part 1
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
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 (if applicable)
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. Urine will be collected at predose, 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 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 (if applicable)
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. Urine will be collected at predose, 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 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 (if applicable)
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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. Urine will be collected at predose, 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 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 Tmax (if applicable)
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. Urine will be collected at predose, 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 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 (if applicable)
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. Urine will be collected at predose, 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 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 (if applicable)
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. Urine will be collected at predose, 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 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 (if applicable)
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. Urine will be collected at predose, 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 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 (if applicable)
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. Urine will be collected at predose, 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 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 Ae (if applicable)
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. Urine will be collected at predose, 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 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 CLr (if applicable)
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. Urine will be collected at predose, 0 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, and 48 to 72 hour post-dose.
Time frame: Up to 72 hours post-dose