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

Insomnia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01673880
• Other study ID #: E2006-A001-005
• Status: Completed
• Phase: Phase 1
• First received: August 22, 2012
• Last updated: May 20, 2013
• Start date: August 2012
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

Drug:
• E2006
2.5 mg, 10 mg, and 25 mg E2006 tablets

Locations

Country	Name	City	State
United States	PPD Development, LLC	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations of E2006 of tablet vs. capsule formulations		up to 336 hours post-dose	No
Secondary	Incidence of adverse events (AEs)		36 days	Yes