The study is designed to investigate the absorption, metabolism, and excretion of EYP001a as well as the safety/tolerability of EYP001a following the administration of a single oral dose to healthy male volunteers. The EYP001a dose is administered in a \[14C\]-labeled form to enable detection and quantitation of dose-related material independent of possible biotransformation.
This is a single site, open-label, mass balance phase 1 study. Six healthy male subjects will receive a single oral dose A of \[14C\]-EYP001a containing 100 μCi radioactivity. * Eligibility is assessed during a screening period of up to 4 weeks. * Subjects will check into the clinic one day prior to dosing (Day -1) for baseline assessments and to (re-)confirm eligibility. * The study drug will be administered on Day 1, after an overnight fast of at least 10 hours. * Blood, urine and fecal samples will be collected up to and including Day 4. If the study discharge criteria are not met on Day 4, blood, urine and fecal samples will be collected in 24- hour intervals until the study discharge criteria are met. * An End of Study Visit will be planned at Day 14 (+/- 1 Day).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Oral drinking suspension
QPS Netherlands B.V.
Groningen, Netherlands
Radioactivity-time profiles in whole blood and plasma
Time frame: Day 1 to Day 4 or until discharge
Cmax
Maximum observed total radioactivity in plasma and whole blood
Time frame: Day 1 to Day 4 or until discharge
tmax
Time from dosing to peak total radioactivity in plasma and whole blood
Time frame: Day 1 to Day 4 or until discharge
AUC0-24
Area under the total radioactivity-time curve in plasma and whole blood from time zero to 24 hours
Time frame: 0 to 24 hours
[14C]-metabolic profile and identification of metabolites in plasma
Time frame: Day 1 to Day 4 or until discharge
[14C]-radioactivity in urine
Time frame: Day 1 to Day 4 or until discharge
[14C]-metabolic profile and identification of metabolites in urine
Time frame: Day 1 to Day 4 or until discharge
[14C]-radioactivity in feces
Time frame: Day 1 to Day 4 or until discharge
[14C]-metabolic profile and identification of metabolites in feces
Time frame: Day 1 to Day 4 or until discharge
Number of subjects with adverse events
Time frame: Day 1 to Day 4 or until discharge
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