This is a single-center, non-randomized, open-label, single-dose, Phase I clinical study to evaluate the mass balance and biotransformation, safety and tolerability of WPV01 in healthy adult chinese male participants following a single oral administration of \[14C\] WPV01.
This trial is planned to enroll 6-8 healthy Chinese male subjects. Each subject is administered a single oral dose containing 600 mg/approximately 100 µCi \[14C\]WPV01 suspension on the first day of the trial in fasting condition. Whole blood, plasma, urine and fecal samples are collected at defined time points/periods during the test. The whole blood/plasma partition ratio, pharmacokinetic parameters of total radioactivity in plasma, recovery and excretion pathway data of \[14C\]WPV01 are calculated by measuring the total radioactivity. The major metabolic elimination pathways and characterization of WPV01 in the human body, as well as circulating metabolites that are close to or above 10% of total plasma radioactivity exposure, are obaitned from structural characterization of plasma, urine and fecal radio-metabolite profiles and major metabolites. All excreted urine and fecal samples are collected at specified time intervals from 0 to 336h post-dose and and blood samples are collected at specified time points from 0 to 144h post-dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Single oral dose of 600 mg \[14C\]-WPV01
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, China
Total recovery and cumulative recovery of total WPV01-related radioactive material in excreta (urine and feces)
Time frame: Up to 168 hours(approx) from drug administration
Total radioactivity of WPV01-related substances in human plasma
Time frame: Up to 168 hours(approx) from drug administration
Ratio of total WPV01-related radioactivity concentrations in human whole blood and plasma at different time points
Time frame: Up to 168 hours(approx) from drug administration
WPV01 and its metabolites in human plasma as a percentage of total plasma radioactivity exposure
Time frame: Up to 168 hours(approx) from drug administration
WPV01 and its metabolites in human excreta (urine and feces) as a percentage of total urine/feces radioactivity exposure
Time frame: Up to 168 hours(approx) from drug administration
Identification of metabolites in plasma
Time frame: Up to 168 hours(approx) from drug administration
Identification of metabolites in urine
Time frame: Up to 168 hours(approx) from drug administration
Identification of metabolites in feces
Time frame: Up to 168 hours(approx) from drug administration
Time to maximum plasma concentration of WPV01 and its metabolites (if applicable) in plasma
Time frame: Up to 168 hours(approx) from drug administration
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Maximum plasma concentration of WPV01 and its metabolites (if applicable) in plasma
Time frame: Up to 168 hours(approx) from drug administration
Terminal half-life of WPV01 and its metabolites (if applicable) in plasma
Time frame: Up to 168 hours(approx) from drug administration
Number of Participants With Adverse Events
Time frame: At least up to 14 days from drug administration
Area under the plasma concentration-time curve of WPV01 and its metabolites (if applicable) in plasma
Time frame: Up to 168 hours(approx) from drug administration
Mean residence time of WPV01 and its metabolites (if applicable) in plasma
Time frame: Up to 168 hours(approx) from drug administration
Number of Participants With Clinically Notable Vital Signs
Time frame: At least up to 14 days from drug administration
Number of Participants With Clinically Notable Laboratory Tests
Time frame: At least up to 14 days from drug administration
Number of Participants With Clinically Notable ECG Tests
Time frame: At least up to 14 days from drug administration
Number of Participants With Clinically Notable Physical Examination
Time frame: At least up to 14 days from drug administration