To investigate the plasma total radioactivity PK characteristics of male healthy subjects after a single oral administration of \[14C\]Clifutinib, the distribution of total radioactivity in whole blood and plasma, and to determine the main excretion and metabolic pathways.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
The subjects are required to take the test drug on an empty stomach for at least 10 hours and without drinking water for 1 hour. After taking the drug, they should fast for 4 hours and refrain from drinking water for 1 hour.
Affiliated hospital of Jiangnan University
Wuxi, Jiangsu, China
AUC0-∞
Investigate the plasma total radioactivity PK characteristics of male healthy subjects after a single oral administration of \[14C\] Clifutinib
Time frame: From Day 1 of dosing to the Day 85 after dosing
Tmax
Investigate the plasma total radioactivity PK characteristics of male healthy subjects after a single oral administration of \[14C\] Clifutinib
Time frame: From Day 1 of dosing to the Day 85 after dosing
Cmax
Investigate the plasma total radioactivity PK characteristics of male healthy subjects after a single oral administration of \[14C\] Clifutinib
Time frame: From Day 1 of dosing to the Day 85 after dosing
Percentage of metabolites in plasma relative to total exposure AUC (% AUC)
Investigate the distribution of total radioactivity in plasma of male healthy subjects after a single oral administration of \[14C\] Clifutinib.
Time frame: From Day 1 of dosing to the Day 85 after dosing
The total radioactivity
Quantitative analysis was conducted on the total radioactivity in the feces and urine of male health subjects after oral administration of \[14C\] Clifutinib, to obtain the data on human recovery rate and determine the main excretion pathway.
Time frame: From Day 1 of dosing to the Day 85 after dosing
Identification of major metabolites in plasma, urine, and fecal samples
Obtain the radioactive metabolite profiles in plasma, urine and feces of male healthy subjects after oral administration of \[14C\]Clifutinib, identify the main metabolites, and determine the metabolic and elimination pathways.
Time frame: From Day 1 of dosing to the Day 85 after dosing
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AUC0-∞
The validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was used to quantitatively analyze the concentrations of Clifutinib, its metabolite (M3), and other metabolites (if applicable) in plasma, thereby obtaining the corresponding pharmacokinetic parameters.
Time frame: From Day 1 of dosing to the Day 85 after dosing
Tmax
The validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was used to quantitatively analyze the concentrations of Clifutinib, its metabolite (M3), and other metabolites (if applicable) in plasma, thereby obtaining the corresponding pharmacokinetic parameters.
Time frame: From Day 1 of dosing to the Day 85 after dosing
Cmax
The validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was used to quantitatively analyze the concentrations of Clifutinib, its metabolite (M3), and other metabolites (if applicable) in plasma, thereby obtaining the corresponding pharmacokinetic parameters.
Time frame: From Day 1 of dosing to the Day 85 after dosing
Frequency, type and severity of adverse events/serious adverse events; changes in vital signs, 12-lead ECGs, laboratory tests, etc.
Observation of the safety profile in male healthy subjects after a single administration of \[14C\] Clifutinib
Time frame: From Day 1 of dosing to the Day 85 after dosing