NCT01975636

An Open-label, Single Dose Study to Determine the Metabolism and Elimination of [14C]E2609 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, single dose study in healthy male subjects.

Detailed description

A baseline (predose) fecal sample and a baseline (predose) urine sample will be obtained at the clinic prior to dosing on Day 1. On Day 1, subjects will begin the Treatment Phase. Subjects will be released from the clinic after at least 10 days since dosing and as soon as the following conditions are met: * greater than 90% of the administered radioactivity has been recovered, and * less than 1% of the administered radioactive dose is recovered in two consecutive 24-hour samples each of urine and feces

Conditions

• Metabolism and Elimination

Interventions

Type	Name	Description
DRUG	E2609	Single oral 100 mg +/- 10 mg E2609 with a level of radioactive exposure consistent with the Radioactive Drug Research Committee allowance

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-11-01
• Completion: 2014-03-01
• First posted: 2013-11-05
• Last updated: 2016-01-08

Locations

2 sites across 1 country: United States