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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01673880
First received: August 22, 2012
Last updated: May 20, 2013
Last verified: March 2013
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events (AEs) [ Time Frame: 36 days ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01673880     History of Changes
Other Study ID Numbers: E2006-A001-005
Study First Received: August 22, 2012
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 25, 2014