<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/NCT01716897</url>
  </required_header>
  <id_info>
    <org_study_id>E2609-A001-007</org_study_id>
    <nct_id>NCT01716897</nct_id>
  </id_info>
  <brief_title>An Study to Determine the Bioavailability of E2609 Tablets Compared to Capsules and the Effect of Food on Absorption</brief_title>
  <official_title>A Randomized, Open-label, 3-treatment Crossover Study to Determine the Bioavailability of E2609 Tablets Compared to Capsules and the Effect of Food on Absorption in Healthy Caucasian Male Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eisai Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eisai Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be a single-center, open-label, randomized, 3-treatment crossover study of&#xD;
      single oral doses of an API-capsule formulation of E2609 under fasted conditions and a tablet&#xD;
      formulation administered under fed and fasted conditions in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">December 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>AUC(0-inf) ratio, new tablet vs. capsule</measure>
    <time_frame>0 -144 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC(0-inf) ratio, fed state vs. fasted state, both after administration of new tablet</measure>
    <time_frame>0 - 144 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax ratio, new tablet vs. capsule</measure>
    <time_frame>0 - 144 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax ratio, fed state vs. fasted state, both after administration of new tablet</measure>
    <time_frame>0 - 144 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence of Adverse events</measure>
    <time_frame>5.5 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>50 mg E2609 capsule formulation in fasted state</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>50 mg E2609 capsule formulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>50 mg E2609 tablet formulation in fasted state</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>50 mg E2609 tablet formulation in fasted state</description>
  </arm_group>
  <arm_group>
    <arm_group_label>50 mg tablet formulation in fed state</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>50 mg E2609 tablet formulation in fed state</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>E2609</intervention_name>
    <arm_group_label>50 mg E2609 capsule formulation in fasted state</arm_group_label>
    <arm_group_label>50 mg E2609 tablet formulation in fasted state</arm_group_label>
    <arm_group_label>50 mg tablet formulation in fed state</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Caucasian males defined as persons of a European or Latin American descent&#xD;
&#xD;
          2. Healthy male 30 to 55 years inclusive at the time of informed consent&#xD;
&#xD;
          3. Body mass index (BMI) of 18 to 32 kg/m2 at Screening&#xD;
&#xD;
          4. Subjects must have had a successful vasectomy (confirmed azoospermia), or they and&#xD;
             their female partners must not be of childbearing potential or must be practicing&#xD;
             highly effective contraception throughout the study period and for 30 days after study&#xD;
             drug discontinuation. No sperm donation is allowed during the study period and for 30&#xD;
             days after study drug discontinuation.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Any history of seizures or epilepsy (not including a history of simple febrile&#xD;
             seizures in childhood) or disturbance of consciousness likely to be due to seizures&#xD;
&#xD;
          2. Any medical condition which, in the opinion of the investigator has high risk of&#xD;
             seizures (e.g., history of traumatic brain injury associated with loss of&#xD;
             consciousness or amnesia, alcohol abuse, substance abuse) at Screening or within past&#xD;
             5 years&#xD;
&#xD;
          3. Any history of cerebrovascular disease (stroke or transient ischemic attack)&#xD;
&#xD;
          4. A history of prolonged QT/QTc interval or prolonged period from the beginning of the&#xD;
             QRS complex to the end of the T wave on an ECG (QT)/ QT corrected for heart rate using&#xD;
             Fridericia?s formula (QTcF) interval (QTcF &amp;gt; 450 ms) as demonstrated by the mean of&#xD;
             triplicate electrocardiogram (ECGs) (recorded at least 1 min apart) at Screening or&#xD;
             Baseline Period&#xD;
&#xD;
          5. Any other clinically significant ECG abnormalities at Screening or Baseline Periods,&#xD;
             e.g. component of the ECG cycle from onset of atrial depolarization to onset of&#xD;
             ventricular depolarization (PR)&amp;gt;220 ms, component of ECG wave representing&#xD;
             ventricular depolarization (QRS)&amp;gt;110 ms&#xD;
&#xD;
          6. Hypersensitivity to the study drugs or any of their excipients&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Haykop Gevorkyan</last_name>
    <role>Principal Investigator</role>
    <affiliation>California Clinical Trials Medical Group/Parexel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>California Clinical Trials/Parexel</name>
      <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>February 2013</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT01716897
org study id: E2609-A001-007
nct id: NCT01716897
lead sponsor: 
has dmc: No
This study will be a single-center, open-label, randomized, 3-treatment crossover study of
      single oral doses of an API-capsule formulation of E2609 under fasted conditions and a tablet
      formulation administered under fed and fasted conditions in healthy subjects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC(0-inf) ratio, new tablet vs. capsule
time frame: 0 -144 hours
measure: AUC(0-inf) ratio, fed state vs. fasted state, both after administration of new tablet
time frame: 0 - 144 hours
measure: Cmax ratio, new tablet vs. capsule
time frame: 0 - 144 hours
measure: Cmax ratio, fed state vs. fasted state, both after administration of new tablet
time frame: 0 - 144 hours
measure: incidence of Adverse events
time frame: 5.5 weeks
arm group label: 50 mg E2609 capsule formulation in fasted state
arm group type: Other
description: 50 mg E2609 capsule formulation
arm group label: 50 mg E2609 tablet formulation in fasted state
arm group type: Other
description: 50 mg E2609 tablet formulation in fasted state
arm group label: 50 mg tablet formulation in fed state
arm group type: Other
description: 50 mg E2609 tablet formulation in fed state
intervention type: Drug
intervention name: E2609
arm group label: 50 mg E2609 capsule formulation in fasted state
arm group label: 50 mg E2609 tablet formulation in fasted state
arm group label: 50 mg tablet formulation in fed state
criteria: 
gender: Male
minimum age: 30 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Haykop Gevorkyan
role: Principal Investigator
affiliation: California Clinical Trials Medical Group/Parexel
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alzheimer Disease