The purpose of this trial is to investigate the fate of the roniciclib (study drug) in the body in a so called mass-balance study. This means to investigate how the study drug is absorbed, distributed, broken down (metabolized) and removed (excreted or eliminated) from the body.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Single dose , 2.5 mg roniciclib spiked with 5.0 MBq of \[14C\] roniciclib solution
5 mg roniciclib tablet , Multiple dose, twice a day (bid), on a 3-days on/4-days off regimen in cycles of 21 days
PRA Magyarorszag Kft. Fazis I-es Klin.Farmakol. Vizsgalohely
Budapest, Hungary
Amount of Roniciclib in urine as percentage of the dose of total radioactivity.
Time frame: Up to 336 hours
Amount of Roniciclib in feces as percentage of the dose of total radioactivity.
Time frame: Up to 336 hours
Amount of Roniciclib in vomit as percentage of the dose of total radioactivity
Time frame: Up to 336 hours
Cmaxof roniciclib in plasma
Time frame: up to 336 hours
AUC(0-tlast) of roniciclib in plasma
Time frame: up to 336 hours
AUC of roniciclib in plasma
Time frame: up to 336 hours
Cmax of total radioactivity in whole blood and plasma
Time frame: up to 336 hours
AUC(0-tlast) of total radioactivity in whole blood and plasma
Time frame: Up to 336 hours
AUC of total radioactivity in whole blood and plasma
Time frame: up to 336 hours
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