This study is a single center, single dose, non-randomized, open design clinical study.By quantitative analysis of the biological samples of subjects after oral administration of \[14C\]JT001, the data of human radioactive excretion rate and the main excretion pathway will be obtained. The main metabolites ,metabolic pathways and elimination pathways of JT001 will be identified.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Subjects will receive approximately 300 mg/100 µCi of \[14C\]JT001 orally.
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Total radioactive recovery
The percentage of radioactivity recovered from collected samples
Time frame: 1 month
cumulative excretion rate of total radioactive material in fecal matter
After oral administration of the drug, the subjects collected feces for 10 Days to obtain the excretion of accumulated radioactive substances in feces
Time frame: 1 month
Peak concentration(Cmax)
The highest plasma drug concentration that can be achieved after medication
Time frame: 1 month
time to peak(Tmax)
After a single dose, the time of peak blood concentration
Time frame: 1 month
elimination half life(t1/2)
the time it takes the blood to reduce the concentration of the drug to half
Time frame: 1 month
Major metabolites in human plasma, urine, and feces by liquid chromatography-mass spectrometry (LC-MS/MS)
The main metabolites in plasma, urine and fecal samples will be identified by liquid chromatography-mass spectrometry (LC-MS/MS)
Time frame: 1 month
Adverse events (AEs)
Number of cases and incidence of adverse events(AEs)
Time frame: 2 month
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