Open-Label Study of Bioavailability of E2006 Tablet Versus Capsule Formulations

Phase 1

Completed

• Conditions: Insomnia
• Interventions: Drug: E2006

• Registration Number: NCT01673880
• Lead Sponsor: Eisai Inc.

Brief Summary

This is a single-center, open-label, randomized crossover study being conducted in three cohorts of healthy adult subjects. Approximately 36 subjects will be randomized to one of three cohorts (approximately 12 subjects per cohort) and they will receive both a single dose of E2006 in capsule formulation and a single dose of E2006 in tablet formulation, in random sequence, at a 1:1 ratio. The doses to be tested will be 2.5 mg, 10 mg, and 25 mg.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-22
• Study First Submitted QC: 2012-08-27
• Study First Posted: 2012-08-28
• Primary Completion: 2012-10
• Study Completion: 2012-12
• Status Verified: 2013-03
• Last Update Submitted: 2013-05-20
• Last Update Posted: 2013-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
E2006 25 mg	E2006	-
E2006 2.5 mg	E2006	-
E2006 10mg	E2006	-

Primary Outcome Measures

Name	Time	Method
Plasma concentrations of E2006 of tablet vs. capsule formulations	up to 336 hours post-dose

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs)	36 days

Trial Locations

Locations (1)

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