This study is a single-center, open-label, single-dose clinical pharmacokinetic study. The purpose of this study is to investigate the absorption characteristics, as well as to evaluate the metabolism and elimination pathways after a single oral dose of 150mg, 100μCi \[14C\]LP-168 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
single dose of 150 mg/100 μCi \[14C\] LP-168, orally suspension at fasted state
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Radioactivity concentration of blood and plasma sample
Use liquid scintillation counter to evaluate Radioactivity concentration of each sample
Time frame: Day 1- Day 8
Radioactivity concentration of urine and feces sample
Use liquid scintillation counter to evaluate Radioactivity concentration of each sample
Time frame: Day 1- Day 15
Number of metabolites and its proportion in plasma, urine and feces.
To study the metabolite profiling
Time frame: Day 1- Day 15
Plasma LP-168/Major Metabolic concentrations
To determine the plasma concentrations of LP-168/Major Metabolic using LC-MS/MS.
Time frame: Day 1- Day 8
Treatment emergent adverse events as assessed by CTCAE 5.0
To evaluate the safety after the study intervention
Time frame: Day 1- Day 15
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