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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: E2006

• Registration Number: NCT02089412
• Lead Sponsor: Eisai Inc.

Brief 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).

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-03-14
• Study First Submitted QC: 2014-03-14
• Study First Posted: 2014-03-17
• Primary Completion: 2014-05
• Study Completion: 2014-06
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
E2006: fasted conditions	E2006	E2006 10-mg will be administered as a single dose under fasted treatment conditions.
E2006: fed conditions	E2006	E2006 10-mg will be administered as a single dose under fed treatment conditions.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of E2006: Maximum Concentration (Cmax)	Up to Day 15 (336 hours)
Pharmacokinetics of E2006: time attain to Cmax (tmax)	Up to Day 15 (336 hours)
Pharmacokinetics of E2006: AUC(t-0)	Up to Day 15 (336 hours)
Pharmacokinetics of E2006: AUC(t-inf)	Up to Day 15 (336 hours)

Trial Locations

Locations (1)

PPD Development LLC; 🇺🇸 Austin, Texas, United States