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

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ClinicalTrials.gov Identifier: NCT01673880
Recruitment Status : Completed
First Posted : August 28, 2012
Last Update Posted : May 22, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Insomnia Drug: E2006 Phase 1

Study Type : Interventional  (Clinical Trial)
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 : August 2012
Primary Completion Date : October 2012
Study Completion Date : December 2012

Arm Intervention/treatment
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



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

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


Information from the National Library of Medicine

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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

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

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