A Phase I, Open-label Study of Absorption-Distribution-Metabolism-Excretion (ADME) of \[14C\]IMP4297 Following a Single Oral Dose to China Healthy Male Subjects
Study design A Phase I, single-center, open-label, single arm study is designed to evaluate Absorption-Distribution-Metabolism-Excretion (ADME) of \[14C\]IMP4297 Following a Single Oral Dose to China Healthy Male Subjects. 6-8 subjects are planned to be enrolled (at least 6 subjects complete the study)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
6
14C marked IMP4297
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Cmax (Maximum concentration)
peak concentration
Time frame: 3 months
Tmax
Time to peak
Time frame: 3 months
AUC0-inf (Area under the curve from time 0 to infinity)
area under the curve from time zero to infinity
Time frame: 3 months
AUC0-last (Area under the curve from time 0 to the last time with quantifiable concentration)
AUC0-last area under the curve from time zero to the time with the last quantifiable concentration
Time frame: 3 months
t½ (Elimination half-life)
elimination half-life
Time frame: 3 months
CL/F (Apparent clearance)
apparent clearance
Time frame: 3 months
Vz/F (apparent volume of distribution )
apparent volume of distribution
Time frame: 3 months
urine and fecal samples for quantification analysis
Assessment of recovery percent in urine and feces by liquid chromatography-radiochemical-detection。 Get Percent (%) of each radiolabeled drug-related material will be determined in urine and feces
Time frame: 3 months
After oral administration of [14C] IMP4297 in healthy volunteers, radioactive metabolite spectrogram are obtained to identify the main metabolites and clarify the main biotransformation pathways.
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Proportion of different metabolites,Assessment of metabolites (metabolites identification and main metabolites) in plasma/urine/faeces by liquid chromatography-radiochemical-detection
Time frame: 3 months