Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-25 @ 4:30 AM
NCT ID:
NCT04037618
Brief Summary:
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.
Detailed Description:
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:
NCT04037618
Study Brief:
Protocol Section:
NCT04037618