NCT04037618

Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C]-EYP001a After a Single Oral Dose

An Open-label, Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C]-EYP001a After a Single Oral Dose to Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Enyo Pharma · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	[14C]-EYP001a	Oral drinking suspension

Timeline

• Start date: 2019-07-24
• Primary completion: 2019-07-27
• Completion: 2019-08-06
• First posted: 2019-07-30
• Last updated: 2019-09-11

Locations

1 site across 1 country: Netherlands