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

• Sponsor: Eisai Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01673880
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 3
• Duration (Months): 4
• Patients Per Site Per Month: 10

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia	Drug: E2006	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Single-center, Open-label, Randomized, Multi-cohort, Crossover Study of Relative Bioavailability of Tablet Versus Capsule Formulation of E2006 in Healthy Adult Subjects
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Plasma concentrations of E2006 of tablet vs. capsule formulations [up to 336 hours post-dose]

Secondary Outcome Measures

1. Incidence of adverse events (AEs) [36 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PPD Development, LLC	Austin	Texas	United States	78704

Sponsors and Collaborators

• Eisai Inc.

Investigators

• Principal Investigator: Aziz Laurent, PPD

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eisai Inc.
• ClinicalTrials.gov Identifier: NCT01673880
• Other Study ID Numbers: E2006-A001-005
• First Posted: Aug 28, 2012
• Last Update Posted: May 22, 2013
• Last Verified: Mar 1, 2013

• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of May 22, 2013