<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01673880</url>
  </required_header>
  <id_info>
    <org_study_id>E2006-A001-005</org_study_id>
    <nct_id>NCT01673880</nct_id>
  </id_info>
  <brief_title>Open-Label Study of Bioavailability of E2006 Tablet Versus Capsule Formulations</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eisai Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eisai Inc.</source>
  <brief_summary>
    <textblock>
      This is a single-center, open-label, randomized crossover study being conducted in three&#xD;
      cohorts of healthy adult subjects. Approximately 36 subjects will be randomized to one of&#xD;
      three cohorts (approximately 12 subjects per cohort) and they will receive both a single dose&#xD;
      of E2006 in capsule formulation and a single dose of E2006 in tablet formulation, in random&#xD;
      sequence, at a 1:1 ratio. The doses to be tested will be 2.5 mg, 10 mg, and 25 mg.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma concentrations of E2006 of tablet vs. capsule formulations</measure>
    <time_frame>up to 336 hours post-dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events (AEs)</measure>
    <time_frame>36 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Insomnia</condition>
  <arm_group>
    <arm_group_label>E2006 2.5 mg</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>E2006 10mg</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>E2006 25 mg</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>E2006</intervention_name>
    <description>2.5 mg, 10 mg, and 25 mg E2006 tablets</description>
    <arm_group_label>E2006 10mg</arm_group_label>
    <arm_group_label>E2006 2.5 mg</arm_group_label>
    <arm_group_label>E2006 25 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion:&#xD;
&#xD;
          -  Healthy males or females,&#xD;
&#xD;
          -  ages 18 to 55 years&#xD;
&#xD;
          -  Body mass index (BMI) &amp;gt;&#xD;
&#xD;
          -  18 and 32 kg/m2 at Screening&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          -  Female subjects who are nursing&#xD;
&#xD;
          -  Subjects with a history of gastrointestinal surgery (hepatectomy, nephrectomy,&#xD;
             digestive organ resection, etc.) that may affect PK profiles of E2006&#xD;
&#xD;
          -  Subjects with a known history of clinically significant drug or food allergies&#xD;
&#xD;
          -  Subjects with a known allergy or hypersensitivity to capsule or tablet ingredients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aziz Laurent</last_name>
    <role>Principal Investigator</role>
    <affiliation>PPD</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PPD Development, LLC</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2013</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>May 20, 2013</last_update_submitted>
  <last_update_submitted_qc>May 20, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 22, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01673880
org study id: E2006-A001-005
nct id: NCT01673880
lead sponsor: 
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Plasma concentrations of E2006 of tablet vs. capsule formulations
time frame: up to 336 hours post-dose
measure: Incidence of adverse events (AEs)
time frame: 36 days
arm group label: E2006 2.5 mg
arm group type: Other
arm group label: E2006 10mg
arm group type: Other
arm group label: E2006 25 mg
arm group type: Other
intervention type: Drug
intervention name: E2006
description: 2.5 mg, 10 mg, and 25 mg E2006 tablets
arm group label: E2006 10mg
arm group label: E2006 2.5 mg
arm group label: E2006 25 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Aziz Laurent
role: Principal Investigator
affiliation: PPD
facility: 
country: United States
responsible party type: Sponsor