<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/NCT02225288</url>
  </required_header>
  <id_info>
    <org_study_id>E2022-J081-007</org_study_id>
    <nct_id>NCT02225288</nct_id>
  </id_info>
  <brief_title>A Study of E2022 Tape Formulation (Overlay-integrated E2022 18 mg Tape Formulation) for Different Application Sites and Intervals in Japanese Healthy Elderly Males</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eisai Co., Ltd.</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 is a single-center, 4-group, open-label study in Japanese healthy elderly males. A total&#xD;
      of 48 subjects will be randomized to one of four groups (A to D, 12 subjects/group) to&#xD;
      administer one E2022 tape to designated sites.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study consists of Screening, Treatment Period, and Follow-up. The Treatment Period is&#xD;
      subdivided into three periods (Periods 1 to 3). Screening will start within 4 weeks before&#xD;
      starting Treatment Period 1. In Treatment Periods 1 and 2, one E2022 tape will be applied to&#xD;
      the designated site. The Treatment Period 2 application must have at least a 17-day interval&#xD;
      from the end of Treatment Period 1 application. In Treatment Period 3, E2022 tape will be&#xD;
      applied to back site (contralateral to the first applied site during Treatment Periods 1 and&#xD;
      2) after at least 17 days from the end of Treatment Period 2 (removing). A new E2022 tape&#xD;
      will be applied to the same site after the specified intervals from the end of previous&#xD;
      application (removing) in each group. Follow-up will start after at least a 17-day interval&#xD;
      from the end of re-application in the Treatment Period 3 (removing).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number and frequency of adverse events</measure>
    <time_frame>168 hours after the end of application</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of E2022: Cmax</measure>
    <time_frame>216 hours after the end of application</time_frame>
    <description>Maximal Drug Concentration (Cmax)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of E2022: AUC</measure>
    <time_frame>216 hours after the end of application</time_frame>
    <description>Area Under the Plasma Concentration-Time Curve (AUC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of E2022: Tmax</measure>
    <time_frame>216 hours after the end of application</time_frame>
    <description>Time to Reach Maximum Observed Plasma Concentration (Tmax)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of E2022: t1/2</measure>
    <time_frame>216 hours after the end of application</time_frame>
    <description>Plasma Decay Half-Life (t1/2)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1: Apply one E2022 tape to the designated site (back or upper arm) for 24 hours (applying in the morning and removing next morning) Period 2: Apply one E2022 tape to the designated site (back or upper arm, but different from Period 1) for 24 hours (applying in the morning and removing next morning) Period 3: Apply one E2022 tape to back (contralateral to Period 1 and 2). After the specified intervals (Group A: 48 hours), apply a new E2022 tape to the same site (for 24 hours after the first and second applications [applying in the morning and removing next morning])</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1: Apply one E2022 tape to the designated site (back or upper arm) for 24 hours (applying in the morning and removing next morning) Period 2: Apply one E2022 tape to the designated site (back or upper arm, but different from Period 1) for 24 hours (applying in the morning and removing next morning) Period 3: Apply one E2022 tape to back (contralateral to Period 1 and 2). After the specified intervals (Group B: 72 hours), apply a new E2022 tape to the same site (for 24 hours after the first and second applications [applying in the morning and removing next morning])</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1: Apply one E2022 tape to the designated site (back or chest) for 24 hours (applying in the morning and removing next morning) Period 2: Apply one E2022 tape to the designated site (back or chest, but different from Period 1) for 24 hours (applying in the morning and removing next morning) Period 3: Apply one E2022 tape to back (contralateral to Period 1 and 2). After the specified intervals (Group C: 96 hours), apply a new E2022 tape to the same site (for 24 hours after the first and second applications [applying in the morning and removing next morning])</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Period 1: Apply one E2022 tape to the designated site (back or chest) for 24 hours (applying in the morning and removing next morning) Period 2: Apply one E2022 tape to the designated site (back or chest, but different from Period 1) for 24 hours (applying in the morning and removing next morning) Period 3: Apply one E2022 tape to back (contralateral to Period 1 and 2). After the specified intervals (Group D: 120 hours), apply a new E2022 tape to the same site (for 24 hours after the first and second applications [applying in the morning and removing next morning])</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>E2022</intervention_name>
    <description>transdermal E2022 tape formulation (8.1 cm x 8.1 cm)</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_label>Group D</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Male non-smokers (not smoking at least 4 weeks before Period 1) aged 65 years or older&#xD;
             at informed consent&#xD;
&#xD;
          2. BMI at screening is 18.5 kg/m2 or above - below 28.0 kg/m2&#xD;
&#xD;
          3. Written informed consent&#xD;
&#xD;
          4. Given full explanation of this study and is willing to and able to comply with the&#xD;
             protocol requirements&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Have a current or past history of disorder requiring medical treatment within 8 weeks&#xD;
             before the first application or infection within 4 weeks before the first application&#xD;
&#xD;
          2. Have a disorder within 4 weeks before the first application which affects the&#xD;
             evaluation of study drug such as psychiatric, gastrointestinal, hepatic, renal,&#xD;
             respiratory, endocrinological, hematological, neurological or cardiovascular system,&#xD;
             or congenital metabolic abnormality&#xD;
&#xD;
          3. Have a history of gastrointestinal surgery (e.g., liver, kidney, digestive tract)&#xD;
             which affects the pharmacokinetics of study drug&#xD;
&#xD;
          4. Have a history of treatment-requiring drug or food allergy or seasonal allergy at&#xD;
             screening&#xD;
&#xD;
          5. Had caffeine-containing food or drink or alcohol within 72 hours before study drug&#xD;
             application in Period 1&#xD;
&#xD;
          6. Had nutritional supplements, herbal preparations (including oriental medicines) or&#xD;
             others (e.g., grapefruit-containing food or beverage) which may affect drug&#xD;
             metabolizing enzymes and transporters, within 1 week before Period 1&#xD;
&#xD;
          7. Have used liquid products (including cosmetics) on study application sites (back,&#xD;
             upper limb, chest), patch, tape or bandage, within 4 weeks before Period 1&#xD;
&#xD;
          8. Present or past clinical signs of skin hypersensitivity to topical product or atopic&#xD;
             dermatitis&#xD;
&#xD;
          9. Excessively hairy or have shaved at application sites (back, upper limb, chest) within&#xD;
             4 weeks before Period 1&#xD;
&#xD;
         10. Eczema, dermatitis, abnormal pigmentation, injury, or scar at application sites which&#xD;
             may affect the evaluation of skin symptoms&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Kagoshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>March 31, 2015</last_update_submitted>
  <last_update_submitted_qc>March 31, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy Subjects</keyword>
  <keyword>Japanese</keyword>
  <keyword>Males</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/NCT02225288
org study id: E2022-J081-007
nct id: NCT02225288
lead sponsor: 
has dmc: No
This is a single-center, 4-group, open-label study in Japanese healthy elderly males. A total
      of 48 subjects will be randomized to one of four groups (A to D, 12 subjects/group) to
      administer one E2022 tape to designated sites.
This study consists of Screening, Treatment Period, and Follow-up. The Treatment Period is
      subdivided into three periods (Periods 1 to 3). Screening will start within 4 weeks before
      starting Treatment Period 1. In Treatment Periods 1 and 2, one E2022 tape will be applied to
      the designated site. The Treatment Period 2 application must have at least a 17-day interval
      from the end of Treatment Period 1 application. In Treatment Period 3, E2022 tape will be
      applied to back site (contralateral to the first applied site during Treatment Periods 1 and
      2) after at least 17 days from the end of Treatment Period 2 (removing). A new E2022 tape
      will be applied to the same site after the specified intervals from the end of previous
      application (removing) in each group. Follow-up will start after at least a 17-day interval
      from the end of re-application in the Treatment Period 3 (removing).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number and frequency of adverse events
time frame: 168 hours after the end of application
measure: Pharmacokinetics of E2022: Cmax
time frame: 216 hours after the end of application
description: Maximal Drug Concentration (Cmax)
measure: Pharmacokinetics of E2022: AUC
time frame: 216 hours after the end of application
description: Area Under the Plasma Concentration-Time Curve (AUC)
measure: Pharmacokinetics of E2022: Tmax
time frame: 216 hours after the end of application
description: Time to Reach Maximum Observed Plasma Concentration (Tmax)
measure: Pharmacokinetics of E2022: t1/2
time frame: 216 hours after the end of application
description: Plasma Decay Half-Life (t1/2)
arm group label: Group A
arm group type: Experimental
description: Period 1: Apply one E2022 tape to the designated site (back or upper arm) for 24 hours (applying in the morning and removing next morning) Period 2: Apply one E2022 tape to the designated site (back or upper arm, but different from Period 1) for 24 hours (applying in the morning and removing next morning) Period 3: Apply one E2022 tape to back (contralateral to Period 1 and 2). After the specified intervals (Group A: 48 hours), apply a new E2022 tape to the same site (for 24 hours after the first and second applications [applying in the morning and removing next morning])
arm group label: Group B
arm group type: Experimental
description: Period 1: Apply one E2022 tape to the designated site (back or upper arm) for 24 hours (applying in the morning and removing next morning) Period 2: Apply one E2022 tape to the designated site (back or upper arm, but different from Period 1) for 24 hours (applying in the morning and removing next morning) Period 3: Apply one E2022 tape to back (contralateral to Period 1 and 2). After the specified intervals (Group B: 72 hours), apply a new E2022 tape to the same site (for 24 hours after the first and second applications [applying in the morning and removing next morning])
arm group label: Group C
arm group type: Experimental
description: Period 1: Apply one E2022 tape to the designated site (back or chest) for 24 hours (applying in the morning and removing next morning) Period 2: Apply one E2022 tape to the designated site (back or chest, but different from Period 1) for 24 hours (applying in the morning and removing next morning) Period 3: Apply one E2022 tape to back (contralateral to Period 1 and 2). After the specified intervals (Group C: 96 hours), apply a new E2022 tape to the same site (for 24 hours after the first and second applications [applying in the morning and removing next morning])
arm group label: Group D
arm group type: Experimental
description: Period 1: Apply one E2022 tape to the designated site (back or chest) for 24 hours (applying in the morning and removing next morning) Period 2: Apply one E2022 tape to the designated site (back or chest, but different from Period 1) for 24 hours (applying in the morning and removing next morning) Period 3: Apply one E2022 tape to back (contralateral to Period 1 and 2). After the specified intervals (Group D: 120 hours), apply a new E2022 tape to the same site (for 24 hours after the first and second applications [applying in the morning and removing next morning])
intervention type: Drug
intervention name: E2022
description: transdermal E2022 tape formulation (8.1 cm x 8.1 cm)
arm group label: Group A
arm group label: Group B
arm group label: Group C
arm group label: Group D
criteria: 
gender: Male
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Japan
responsible party type: Sponsor