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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-EYP001a | Experimental | [14C]-EYP001a dose A containing 100 μCi radioactivity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-EYP001a | Drug | Oral drinking suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radioactivity-time profiles in whole blood and plasma | Day 1 to Day 4 or until discharge | |
| Cmax | Maximum observed total radioactivity in plasma and whole blood | Day 1 to Day 4 or until discharge |
| tmax | Time from dosing to peak total radioactivity in plasma and whole blood | 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 | 0 to 24 hours |
| [14C]-metabolic profile and identification of metabolites in plasma | Day 1 to Day 4 or until discharge | |
| [14C]-radioactivity in urine | Day 1 to Day 4 or until discharge | |
| [14C]-metabolic profile and identification of metabolites in urine | Day 1 to Day 4 or until discharge | |
| [14C]-radioactivity in feces | Day 1 to Day 4 or until discharge | |
| [14C]-metabolic profile and identification of metabolites in feces | Day 1 to Day 4 or until discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | Day 1 to Day 4 or until discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| C. Voors-Pette, MD | QPS Netherlands B.V. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QPS Netherlands B.V. | Groningen | 9713 | Netherlands |
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