<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/NCT02192515</url>
  </required_header>
  <id_info>
    <org_study_id>APD356-J081-101</org_study_id>
    <nct_id>NCT02192515</nct_id>
  </id_info>
  <brief_title>A Study of APD356 (Lorcaserin) in Healthy Japanese Adult Subjects</brief_title>
  <official_title>A Phase 1 Study of APD356 (Lorcaserin) in Healthy Japanese Adult Subjects</official_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>
      The purpose of this study is to assess the safety and pharmacokinetics of APD356 in healthy&#xD;
      Japanese adult subjects. Regarding cohorts 1 to 3, this study is a single center,&#xD;
      placebo-controlled, randomized,double-blind study. Regarding cohort 4, this study is a single&#xD;
      center, randomized, open-label study that consists of two sequential two-way crossover&#xD;
      studies. The study consists of 4 cohorts. In cohort 1, subjects will be randomized to 10 mg&#xD;
      group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug. In&#xD;
      cohort 2, subjects will be randomized to 20 mg group (6 subjects) or placebo group (2&#xD;
      subjects) to receive single dose of study drug. In cohort 3, subjects will be randomized to&#xD;
      XR-20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study&#xD;
      drug on Day 1 and multiple doses of study drug on Day 8-14 once daily before breakfast. In&#xD;
      cohort 4, subjects will be randomized to Sequence A (8 subjects) or Sequence B (8 subjects)&#xD;
      to receive study drug in the sequence shown below.&#xD;
&#xD;
      Sequence A: 10 mg tablet, 2 doses (12 hours apart) =&gt; XR-20 mg orange tablet, single dose =&gt;&#xD;
      XR-20 mg orange tablet, q. d., multiple doses (fasted) =&gt; XR-20 mg orange tablet, q. d.,&#xD;
      multiple dose (fed)&#xD;
&#xD;
      Sequence B: XR-20 mg orange tablet, single dose =&gt; 10 mg tablet, 2 doses (12 hours apart) =&gt;&#xD;
      XR-20 mg orange tablet, q. d., multiple dose (fed) =&gt; XR-20 mg orange tablet, q. d., multiple&#xD;
      doses (fasted)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">November 2015</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>Safety as assessed by adverse events (AEs), clinical laboratory tests, vital signs, body weight and ECGs</measure>
    <time_frame>Up to 30 days after last dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of APD356: Cmax</measure>
    <time_frame>Up to 96 hours after last dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of APD356: tmax</measure>
    <time_frame>Up to 96 hours after last dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of APD356: AUC</measure>
    <time_frame>Up to 96 hours after last dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of APD356: t1/2</measure>
    <time_frame>Up to 96 hours after last dose</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>APD356 10 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be randomized to APD356 10 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>APD356 20 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be randomized to APD356 20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>APD356 XR-20 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be randomized to APD356 XR-20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug on Day 1 and multiple doses of study drug on Day 8-14 once daily before breakfast.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>APD356 10 mg and APD356 XR-20mg (orange tablet)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be randomized to Sequence A (8 subjects) or Sequence B (8 subjects) to receive study drug in the sequence shown below.&#xD;
Sequence A: 10 mg tablet, 2 doses (12 hours apart) =&gt; XR-20 mg orange tablet, single dose =&gt; XR-20 mg orange tablet, q. d., multiple doses (fasted) =&gt; XR-20 mg orange tablet, q. d., multiple dose (fed)&#xD;
Sequence B: XR-20 mg orange tablet, single dose =&gt; 10 mg tablet, 2 doses (12 hours apart) =&gt; XR-20 mg orange tablet, q. d., multiple dose (fed) =&gt; XR-20 mg orange tablet, q. d., multiple doses (fasted)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>APD356 10 mg</intervention_name>
    <description>One tablet of APD356 10 mg will be orally administered in fasted state.</description>
    <arm_group_label>APD356 10 mg</arm_group_label>
    <arm_group_label>APD356 10 mg and APD356 XR-20mg (orange tablet)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>APD356 XR-20 mg</intervention_name>
    <description>One tablet of APD356 XR-20 mg will be orally administered in fasted state.</description>
    <arm_group_label>APD356 XR-20 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>APD356 10 mg matching Placebo</intervention_name>
    <description>One tablet of APD356 10 mg matching placebo will be orally administered in fasted state.</description>
    <arm_group_label>APD356 10 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>APD356 XR-20 mg matching Placebo</intervention_name>
    <description>One tablet of APD356 XR matching placebo will be orally administered in fasted state.</description>
    <arm_group_label>APD356 XR-20 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>APD356 20 mg</intervention_name>
    <description>Two tablets of APD356 10 mg will be orally administered in fasted state.</description>
    <arm_group_label>APD356 20 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>APD356 20 mg matching Placebo</intervention_name>
    <description>Two tablets of APD356 10 mg matching placebo will be orally administered in fasted state.</description>
    <arm_group_label>APD356 20 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>APD356 XR-20 mg (orange tablet)</intervention_name>
    <description>One tablet of APD356 XR-20 mg orange tablet will be orally administered in fasted state.</description>
    <arm_group_label>APD356 10 mg and APD356 XR-20mg (orange tablet)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>APD356 XR-20mg (orange tablet, fed state)</intervention_name>
    <description>One tablet of APD356 XR-20 mg orange tablet will be orally administered 30 minutes after the start of a meal.</description>
    <arm_group_label>APD356 10 mg and APD356 XR-20mg (orange tablet)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        Subjects must meet all of the following criteria to be included in this study:&#xD;
&#xD;
          1. Non-smoking, healthy Japanese male subjects age greater than or equal to 20 years and&#xD;
             less than 55 years old at the time of informed consent. To be considered non-smokers,&#xD;
             subject must have discontinued smoking for at least 4 weeks prior to dosing.&#xD;
&#xD;
          2. BMI greater than or equal to 23 and less than 32 kg/m2 at Screening&#xD;
&#xD;
             a) BMI (kg/m2) = body weight(kg)/[height(m) x height(m)]&#xD;
&#xD;
          3. Provide written informed consent&#xD;
&#xD;
          4. Willing and able to comply with all aspects of the protocol&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        Subjects who meet any of the following criteria will be excluded from this study:&#xD;
&#xD;
          1. Clinically significant illness that requires medical treatment within 8 weeks or a&#xD;
             clinically significant infection that requires medical treatment within 4 weeks of&#xD;
             dosing&#xD;
&#xD;
          2. Evidence of disease that may influence the outcome of the study within 4 weeks prior&#xD;
             to dosing; eg, psychiatric disorders and disorders of the gastrointestinal tract,&#xD;
             liver, kidney, respiratory system, endocrine system, hematological system,&#xD;
             neurological system, or cardiovascular system, or subjects who have a congenital&#xD;
             abnormality in metabolism&#xD;
&#xD;
          3. Any history of gastrointestinal surgery that may affect PK profiles of study drug, eg,&#xD;
             hepatectomy, nephrotomy, digestive organ resection at Screening&#xD;
&#xD;
          4. Any clinically abnormal symptom or organ impairment found by medical history at&#xD;
             Screening, and physical examinations, vital signs, ECG finding, or laboratory test&#xD;
             results that require medical treatment at Screening&#xD;
&#xD;
          5. A prolonged QT/QTc interval (QTc greater than 450 ms) demonstrated on ECG at Screening&#xD;
             or Baseline&#xD;
&#xD;
          6. Known history of clinically significant drug allergy at Screening&#xD;
&#xD;
          7. Known history of food allergies or presently experiencing significant seasonal or&#xD;
             perennial allergy at Screening&#xD;
&#xD;
          8. Known to be human immunodeficiency virus (HIV) positive at Screening&#xD;
&#xD;
          9. Positive results for Hepatitis B surface antigen (HBs Ag), Hepatitis C virus antibody&#xD;
             (HCV Ab) or Syphilis test at Screening&#xD;
&#xD;
         10. History of drug or alcohol dependency or abuse, or those who have a positive urine&#xD;
             drug test at Screening or Baseline&#xD;
&#xD;
         11. Intake of caffeinated beverages or food within 72 hours prior to dosing&#xD;
&#xD;
         12. Intake of nutritional supplements, juice, and herbal preparations or other foods or&#xD;
             beverages that may affect the various drug metabolizing enzymes and transporters (eg,&#xD;
             alcohol and grapefruit juice) within 1 week prior to dosing&#xD;
&#xD;
         13. Intake of herbal preparations containing St. John's Wort within 4 weeks prior to&#xD;
             dosing&#xD;
&#xD;
         14. Use of prescription drugs (except for disinfectants, eye drops) within 4 weeks prior&#xD;
             to dosing&#xD;
&#xD;
         15. Intake of over-the-counter (OTC) medications (except for disinfectants, eye drops)&#xD;
             within 2 weeks prior to dosing&#xD;
&#xD;
         16. Currently enrolled in another clinical study or used any investigational drug or&#xD;
             device within 16 weeks preceding informed consent&#xD;
&#xD;
         17. Subjects who undergo blood transfusion within 12 weeks, or who donate 400 mL or more&#xD;
             of whole blood within 12 weeks (16 weeks for woman) or 200 mL or more of whole blood&#xD;
             within 4 weeks, or who make a component donation within 2 weeks prior to dosing.&#xD;
&#xD;
         18. Engagement in strenuous exercise within 2 weeks prior to check-in (eg, marathon&#xD;
             runners, weight lifters, etc.)&#xD;
&#xD;
         19. Subjects who have any condition that would make them, in the opinion of the&#xD;
             investigator, unsuitable for the study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>54 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Toshima-Ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>February 8, 2016</last_update_submitted>
  <last_update_submitted_qc>February 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 10, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy Subjects</keyword>
  <keyword>Japanese Adult</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/NCT02192515
org study id: APD356-J081-101
nct id: NCT02192515
lead sponsor: 
has dmc: No
The purpose of this study is to assess the safety and pharmacokinetics of APD356 in healthy
      Japanese adult subjects. Regarding cohorts 1 to 3, this study is a single center,
      placebo-controlled, randomized,double-blind study. Regarding cohort 4, this study is a single
      center, randomized, open-label study that consists of two sequential two-way crossover
      studies. The study consists of 4 cohorts. In cohort 1, subjects will be randomized to 10 mg
      group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug. In
      cohort 2, subjects will be randomized to 20 mg group (6 subjects) or placebo group (2
      subjects) to receive single dose of study drug. In cohort 3, subjects will be randomized to
      XR-20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study
      drug on Day 1 and multiple doses of study drug on Day 8-14 once daily before breakfast. In
      cohort 4, subjects will be randomized to Sequence A (8 subjects) or Sequence B (8 subjects)
      to receive study drug in the sequence shown below.

      Sequence A: 10 mg tablet, 2 doses (12 hours apart) => XR-20 mg orange tablet, single dose =>
      XR-20 mg orange tablet, q. d., multiple doses (fasted) => XR-20 mg orange tablet, q. d.,
      multiple dose (fed)

      Sequence B: XR-20 mg orange tablet, single dose => 10 mg tablet, 2 doses (12 hours apart) =>
      XR-20 mg orange tablet, q. d., multiple dose (fed) => XR-20 mg orange tablet, q. d., multiple
      doses (fasted)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Safety as assessed by adverse events (AEs), clinical laboratory tests, vital signs, body weight and ECGs
time frame: Up to 30 days after last dose
measure: Pharmacokinetics of APD356: Cmax
time frame: Up to 96 hours after last dose
measure: Pharmacokinetics of APD356: tmax
time frame: Up to 96 hours after last dose
measure: Pharmacokinetics of APD356: AUC
time frame: Up to 96 hours after last dose
measure: Pharmacokinetics of APD356: t1/2
time frame: Up to 96 hours after last dose
arm group label: APD356 10 mg
arm group type: Experimental
description: Subjects will be randomized to APD356 10 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug.
arm group label: APD356 20 mg
arm group type: Experimental
description: Subjects will be randomized to APD356 20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug.
arm group label: APD356 XR-20 mg
arm group type: Experimental
description: Subjects will be randomized to APD356 XR-20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug on Day 1 and multiple doses of study drug on Day 8-14 once daily before breakfast.
arm group label: APD356 10 mg and APD356 XR-20mg (orange tablet)
arm group type: Experimental
description: Subjects will be randomized to Sequence A (8 subjects) or Sequence B (8 subjects) to receive study drug in the sequence shown below.
Sequence A: 10 mg tablet, 2 doses (12 hours apart) => XR-20 mg orange tablet, single dose => XR-20 mg orange tablet, q. d., multiple doses (fasted) => XR-20 mg orange tablet, q. d., multiple dose (fed)
Sequence B: XR-20 mg orange tablet, single dose => 10 mg tablet, 2 doses (12 hours apart) => XR-20 mg orange tablet, q. d., multiple dose (fed) => XR-20 mg orange tablet, q. d., multiple doses (fasted)
intervention type: Drug
intervention name: APD356 10 mg
description: One tablet of APD356 10 mg will be orally administered in fasted state.
arm group label: APD356 10 mg
arm group label: APD356 10 mg and APD356 XR-20mg (orange tablet)
intervention type: Drug
intervention name: APD356 XR-20 mg
description: One tablet of APD356 XR-20 mg will be orally administered in fasted state.
arm group label: APD356 XR-20 mg
intervention type: Drug
intervention name: APD356 10 mg matching Placebo
description: One tablet of APD356 10 mg matching placebo will be orally administered in fasted state.
arm group label: APD356 10 mg
intervention type: Drug
intervention name: APD356 XR-20 mg matching Placebo
description: One tablet of APD356 XR matching placebo will be orally administered in fasted state.
arm group label: APD356 XR-20 mg
intervention type: Drug
intervention name: APD356 20 mg
description: Two tablets of APD356 10 mg will be orally administered in fasted state.
arm group label: APD356 20 mg
intervention type: Drug
intervention name: APD356 20 mg matching Placebo
description: Two tablets of APD356 10 mg matching placebo will be orally administered in fasted state.
arm group label: APD356 20 mg
intervention type: Drug
intervention name: APD356 XR-20 mg (orange tablet)
description: One tablet of APD356 XR-20 mg orange tablet will be orally administered in fasted state.
arm group label: APD356 10 mg and APD356 XR-20mg (orange tablet)
intervention type: Drug
intervention name: APD356 XR-20mg (orange tablet, fed state)
description: One tablet of APD356 XR-20 mg orange tablet will be orally administered 30 minutes after the start of a meal.
arm group label: APD356 10 mg and APD356 XR-20mg (orange tablet)
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 54 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Japan
responsible party type: Sponsor