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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01673880
First Posted: August 28, 2012
Last Update Posted: May 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eisai Inc.
  Purpose
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 Intervention Phase
Insomnia Drug: E2006 Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Plasma concentrations of E2006 of tablet vs. capsule formulations [ Time Frame: up to 336 hours post-dose ]

Secondary Outcome Measures:
  • Incidence of adverse events (AEs) [ Time Frame: 36 days ]

Enrollment: 40
Study Start Date: August 2012
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
E2006 2.5 mg Drug: E2006
2.5 mg, 10 mg, and 25 mg E2006 tablets
E2006 10mg Drug: E2006
2.5 mg, 10 mg, and 25 mg E2006 tablets
E2006 25 mg Drug: E2006
2.5 mg, 10 mg, and 25 mg E2006 tablets

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01673880


Locations
United States, Texas
PPD Development, LLC
Austin, Texas, United States, 78704
Sponsors and Collaborators
Eisai Inc.
Investigators
Principal Investigator: Aziz Laurent PPD
  More Information

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01673880     History of Changes
Other Study ID Numbers: E2006-A001-005
First Submitted: August 22, 2012
First Posted: August 28, 2012
Last Update Posted: May 22, 2013
Last Verified: March 2013