NCT02089412

A Study to Determine the Effect of a High-Fat Meal on the Rate and Extent of E2006 Absorption in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, single-dose, randomized crossover study of single oral 10-mg tablet doses administered either after an overnight fast or in combination with a standard high-fat meal in healthy subjects.

Detailed description

The study will have 2 phases: Prerandomization and Randomization. The Prerandomization Phase will consist of 2 periods: Screening and Baseline (Baseline Period 1), during which each subject�s study eligibility will be determined and baseline assessments will be conducted. During this phase, each eligible subject will be randomized to 1 of 2 treatment sequences to receive single oral doses of E2006 10 mg under fasted and fed conditions. The Randomization Phase will consist of 3 periods: administration of the first randomized dose (Treatment Period 1), baseline for the second randomized dose (Baseline Period 2), and administration of the second randomized dose (Treatment Period 2).

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	E2006

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-05-01
• Completion: 2014-06-01
• First posted: 2014-03-17
• Last updated: 2015-11-03

Locations

1 site across 1 country: United States