<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/NCT01673451</url>
  </required_header>
  <id_info>
    <org_study_id>E2006-A001-002</org_study_id>
    <nct_id>NCT01673451</nct_id>
  </id_info>
  <brief_title>2-Part Multiple Ascending Dose Study for Safety and Pharmacokinetics in Healthy and Elderly Subjects</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of E2006 in Healthy Adult and Elderly 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, randomized, double-blind, placebo-controlled, sequential,&#xD;
      multiple-dose study. The study will be conducted in two parts: Part A (6 cohorts of healthy&#xD;
      adults receiving evening dosing) and Part B (one cohort of elderly adults receiving evening&#xD;
      dosing).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Adverse events (AEs)</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma concentrations of E2006</measure>
    <time_frame>Part A up to 288 hours postdose; Part B: up to 324 hours postdose</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>CNS</condition>
  <arm_group>
    <arm_group_label>Placebo comparator</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>E2006</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>E2006</intervention_name>
    <description>Part A: 2.5 mg, 5 mg, 10 mg, 25 mg, 50 mg, and 75 mg E2006 administered as capsules</description>
    <arm_group_label>E2006</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo comparator</intervention_name>
    <description>E2006-matched placebo (Part A and Part B); Part B: dose level to be determined based on results of Part A, administered as capsules</description>
    <arm_group_label>Placebo comparator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Included:&#xD;
&#xD;
          -  Healthy males or females, ages 18 to 55 years (Part A) or 65 to 80 years (Part B)&#xD;
&#xD;
          -  Who report typical time in bed 7.5 to 9 hours&#xD;
&#xD;
          -  Who report typical bedtime 22:00 - 24:00 and typical wake time 06:00 - 08:00&#xD;
&#xD;
          -  Who report typical sleep latency of &lt;= 30 minutes&#xD;
&#xD;
          -  All females must be of non-childbearing potential, or subjects who have been&#xD;
             sterilized surgically or who are otherwise proven sterile. Females must have a&#xD;
             negative serum beta-human chorionic gonadotropin (Beta-hCG) test result at Screening&#xD;
             and a negative urine pregnancy test at Baseline.&#xD;
&#xD;
          -  Body mass index BMI &gt; 18 and 32 kg/m2 at Screening&#xD;
&#xD;
        Excluded:&#xD;
&#xD;
          -  Performed shift work within 2 weeks prior to Screening&#xD;
&#xD;
          -  Had taken a flight across three or more time zones in the 7 days prior to Screening&#xD;
&#xD;
          -  Female subjects who are nursing&#xD;
&#xD;
          -  With a history of gastrointestinal surgery (hepatectomy, nephrectomy, digestive organ&#xD;
             resection, etc.) that may affect PK profile of E2006&#xD;
&#xD;
          -  With a known history of clinically significant drug or food allergies or presently&#xD;
             experiencing significant seasonal allergy&#xD;
&#xD;
          -  Hypersensitivity to the study drug or any of the excipients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dohwa Kim</last_name>
    <role>Principal Investigator</role>
    <affiliation>Parexel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Parexel, California Clinical Trials</name>
      <address>
        <city>Culver City</city>
        <state>California</state>
        <zip>90232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2013</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>October 10, 2013</last_update_submitted>
  <last_update_submitted_qc>October 10, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 11, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>insomnia</keyword>
  <!-- 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/NCT01673451
org study id: E2006-A001-002
nct id: NCT01673451
lead sponsor: 
This is a single-center, randomized, double-blind, placebo-controlled, sequential,
      multiple-dose study. The study will be conducted in two parts: Part A (6 cohorts of healthy
      adults receiving evening dosing) and Part B (one cohort of elderly adults receiving evening
      dosing).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Incidence of Adverse events (AEs)
time frame: 28 days
measure: Plasma concentrations of E2006
time frame: Part A up to 288 hours postdose; Part B: up to 324 hours postdose
arm group label: Placebo comparator
arm group type: Placebo Comparator
arm group label: E2006
arm group type: Experimental
intervention type: Drug
intervention name: E2006
description: Part A: 2.5 mg, 5 mg, 10 mg, 25 mg, 50 mg, and 75 mg E2006 administered as capsules
arm group label: E2006
intervention type: Drug
intervention name: Placebo comparator
description: E2006-matched placebo (Part A and Part B); Part B: dose level to be determined based on results of Part A, administered as capsules
arm group label: Placebo comparator
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dohwa Kim
role: Principal Investigator
affiliation: Parexel
facility: 
facility: 
country: United States
responsible party type: Sponsor