NCT02116907

An Open-Label, Single-Dose Study to Determine the Metabolism and Elimination of 14C-Perampanel in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (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. The study will have 2 phases: Pretreatment and Treatment. The Pretreatment Phase will last up to 21 days and will consist of a Screening Period and a Baseline Period, during which each subject's study eligibility will be determined and baseline assessments will be conducted.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	E2007	14C-labeled perampanel dissolved in ethanol and administered using a capsule formulation in a single dose, one day

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-07-01
• Completion: 2014-09-01
• First posted: 2014-04-17
• Last updated: 2015-11-03

Locations

1 site across 1 country: United States