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

A Single-center, Open-label, Randomized, Multi-cohort, Crossover Study of Relative Bioavailability of Tablet Versus Capsule Formulation of E2006 in Healthy Adult Subjects

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.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Drug: E2006

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78704
      • Ppd Development, Llc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion:

• Healthy males or females,
• ages 18 to 55 years
• Body mass index (BMI) >
• 18 and 32 kg/m2 at Screening

Exclusion:

• Female subjects who are nursing
• Subjects with a history of gastrointestinal surgery (hepatectomy, nephrectomy, digestive organ resection, etc.) that may affect PK profiles of E2006
• Subjects with a known history of clinically significant drug or food allergies
• Subjects with a known allergy or hypersensitivity to capsule or tablet ingredients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: E2006 2.5 mg	Drug: E2006; 2.5 mg, 10 mg, and 25 mg E2006 tablets
OTHER: E2006 10mg	Drug: E2006; 2.5 mg, 10 mg, and 25 mg E2006 tablets
OTHER: E2006 25 mg	Drug: E2006; 2.5 mg, 10 mg, and 25 mg E2006 tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma concentrations of E2006 of tablet vs. capsule formulations	up to 336 hours post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events (AEs)	36 days

Collaborators and Investigators

• Sponsor: Eisai Inc.
• Investigators: Principal Investigator: Aziz Laurent, PPD

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: August 22, 2012
• First Submitted That Met QC Criteria: August 27, 2012
• First Posted (ESTIMATE): August 28, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): May 22, 2013
• Last Update Submitted That Met QC Criteria: May 20, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: E2006-A001-005