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OpenTrials
Completed

NCT Number: NCT01673880

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

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Development, LLC

Austin, Texas, 78704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

E2006

Drug

2.5 mg, 10 mg, and 25 mg E2006 tablets

Primary outcomes

  1. Plasma concentrations of E2006 of tablet vs. capsule formulations

    Time frame: up to 336 hours post-dose

Secondary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: 36 days

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 28, 2012
Registry last updated
May 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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