<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/NCT03014895</url>
  </required_header>
  <id_info>
    <org_study_id>E3112/CP1</org_study_id>
    <nct_id>NCT03014895</nct_id>
  </id_info>
  <brief_title>A Single Intravenous Dose Study of E3112 in Japanese Healthy Adult Male Subjects</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Single Intravenous Ascending Dose Study of E3112 in Japanese Healthy Adult Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>EA Pharma Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eisai Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study (E3112/CP1) is a single-center, randomized, double-blind, placebo-controlled,&#xD;
      single intravenous ascending dose study conducted in Japanese healthy adult males to evaluate&#xD;
      the pharmacokinetics (PK), safety, and immunogenicity of E3112 following a single intravenous&#xD;
      dose of E3112.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 25, 2017</start_date>
  <completion_date type="Actual">November 22, 2017</completion_date>
  <primary_completion_date type="Actual">June 12, 2017</primary_completion_date>
  <phase>Early 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>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peak concentration (Cmax) of E3112</measure>
    <time_frame>Days 1 to 4, 8, 14, and 28</time_frame>
    <description>Cmax is the maximum observed concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to peak concentration (Tmax) of E3112</measure>
    <time_frame>Days 1 to 4, 8, 14, and 28</time_frame>
    <description>Tmax is the time from dosing to reach the maximum observed concentration a drug achieves in a specified compartment or test area of the body after the drug has been administered.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the curve (AUC)</measure>
    <time_frame>Days 1 to 4, 8, 14, and 28</time_frame>
    <description>AUC is the area under the curve in a plot of concentration of drug in blood plasma against time. AUC represents the total drug exposure over a defined period of time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Half-life of elimination (t1/2) of E3112</measure>
    <time_frame>Days 1 to 4, 8, 14, and 28</time_frame>
    <description>t1/2 is the time required for the concentration of the drug to reach half of its original value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clearance of E3112</measure>
    <time_frame>Days 1 to 4, 8, 14, and 28</time_frame>
    <description>Clearance is defined as the rate of drug elimination divided by the plasma concentration of the drug.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Volume of distribution (Vd) of E3112</measure>
    <time_frame>Days 1 to 4, 8, 14, and 28</time_frame>
    <description>Vd is the theoretical volume that would be necessary to contain the total amount of an administered drug at the same concentration that it is observed in the blood plasma.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with any serious adverse event and any non-serious adverse event</measure>
    <time_frame>Days 1 to 28</time_frame>
    <description>An adverse event is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A serious adverse event is defined as any adverse event occurring at any dose that results in any of the following outcomes: results in death; is life threatening; results in inpatient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life function; results in a congenital anomaly/birth defect; or can be defined as any other important medical event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with an abnormal, clinically significant hematology parameter value</measure>
    <time_frame>Days 1 to 28</time_frame>
    <description>Clinical significance will be determined by the investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with an abnormal, clinically significant blood chemistry parameter value</measure>
    <time_frame>Days 1 to 28</time_frame>
    <description>Clinical significance will be determined by the investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with an abnormal, clinically significant urine value</measure>
    <time_frame>Days 1 to 28</time_frame>
    <description>Clinical significance will be determined by the investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with an abnormal, clinically significant vital sign measurement</measure>
    <time_frame>Baseline; Days 1 to 28</time_frame>
    <description>Clinical significance will be determined by the investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with an abnormal, clinically significant electrocardiogram (ECG) measurement</measure>
    <time_frame>Baseline; Days 1 to 28</time_frame>
    <description>Clinical significance will be determined by the investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with an abnormal, clinically significant physical examination measurement</measure>
    <time_frame>Baseline; Days 1 to 28</time_frame>
    <description>Clinical significance will be determined by the investigator.</description>
  </secondary_outcome>
  <number_of_arms>10</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Healthy Male Volunteers</condition>
  <arm_group>
    <arm_group_label>Cohort 1: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intravenous placebo infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1: E3112</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous E3112 infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intravenous placebo infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: E3112</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous E3112 infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intravenous placebo infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3: E3112</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous E3112 infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intravenous placebo infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4: E3112</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous E3112 infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 5: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intravenous placebo infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 5: E3112</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous E3112 infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Intravenous infusion</description>
    <arm_group_label>Cohort 1: Placebo</arm_group_label>
    <arm_group_label>Cohort 2: Placebo</arm_group_label>
    <arm_group_label>Cohort 3: Placebo</arm_group_label>
    <arm_group_label>Cohort 4: Placebo</arm_group_label>
    <arm_group_label>Cohort 5: Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>E3112</intervention_name>
    <description>Intravenous infusion</description>
    <arm_group_label>Cohort 1: E3112</arm_group_label>
    <arm_group_label>Cohort 2: E3112</arm_group_label>
    <arm_group_label>Cohort 3: E3112</arm_group_label>
    <arm_group_label>Cohort 4: E3112</arm_group_label>
    <arm_group_label>Cohort 5: E3112</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Main Inclusion Criteria:&#xD;
&#xD;
          -  Non-smoking, Japanese, male participants, ≥20 and &lt;45 years old at the time of&#xD;
             obtaining informed consent&#xD;
&#xD;
          -  Have a Body Mass Index (BMI) ≥18.5 and &lt;25.0 kilograms per meters squared (kg/m^2) at&#xD;
             Screening&#xD;
&#xD;
          -  Able to provide written informed consent of their free will&#xD;
&#xD;
          -  Males who were given a full explanation of all the requirements of the protocol, and&#xD;
             are willing and able to comply with them&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Main Exclusion Criteria:&#xD;
&#xD;
          -  Male and his partner who do not agree to use a highly effective method of&#xD;
             contraception throughout the entire study period, if he has reproductive capacity&#xD;
&#xD;
          -  Male who had or has any malignant tumor, lymphoma, leukaemia, or lymphoproliferative&#xD;
             disorders. Clinically significant illness that required medical treatment within 8&#xD;
             weeks or a clinically significant infection within 4 weeks prior to dosing.&#xD;
&#xD;
          -  Evidence of disease that may influence the outcome of the study within 4 weeks prior&#xD;
             to dosing&#xD;
&#xD;
          -  Any history of surgical treatment that may affect pharmacokinetic (PK) profiles of&#xD;
             study drug at Screening&#xD;
&#xD;
          -  Any suspected clinically abnormal symptom or organ impairment that require medical&#xD;
             treatment at Screening or Baseline&#xD;
&#xD;
          -  Receipt of vaccination within 4 weeks prior to dosing&#xD;
&#xD;
          -  History of drug or alcohol dependency or abuse prior to Screening&#xD;
&#xD;
          -  Intake of caffeinated beverages or food within 72 hours prior to dosing&#xD;
&#xD;
          -  Use of prescription drugs within 4 weeks prior to dosing&#xD;
&#xD;
          -  Intake of over-the-counter (OTC) medications within 2 weeks prior to dosing&#xD;
&#xD;
          -  Male who is currently being enrolled in another clinical study or used any&#xD;
             investigational drug or device in another clinical study within 16 weeks prior to&#xD;
             dosing&#xD;
&#xD;
          -  Male who underwent a blood transfusion within 12 weeks prior to dosing, who donate 400&#xD;
             milliliters (mL) or more of whole blood within 12 weeks prior to dosing, who donate&#xD;
             200 mL or more of whole blood within 4 weeks prior to dosing, or who made a component&#xD;
             donation within 2 weeks prior to dosing&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>EA Pharma Trial Site</name>
      <address>
        <city>Toshima</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>November 12, 2018</last_update_submitted>
  <last_update_submitted_qc>November 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>E3112</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Japanese</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03014895
org study id: E3112/CP1
nct id: NCT03014895
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study (E3112/CP1) is a single-center, randomized, double-blind, placebo-controlled,
      single intravenous ascending dose study conducted in Japanese healthy adult males to evaluate
      the pharmacokinetics (PK), safety, and immunogenicity of E3112 following a single intravenous
      dose of E3112.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Peak concentration (Cmax) of E3112
time frame: Days 1 to 4, 8, 14, and 28
description: Cmax is the maximum observed concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered.
measure: Time to peak concentration (Tmax) of E3112
time frame: Days 1 to 4, 8, 14, and 28
description: Tmax is the time from dosing to reach the maximum observed concentration a drug achieves in a specified compartment or test area of the body after the drug has been administered.
measure: Area under the curve (AUC)
time frame: Days 1 to 4, 8, 14, and 28
description: AUC is the area under the curve in a plot of concentration of drug in blood plasma against time. AUC represents the total drug exposure over a defined period of time.
measure: Half-life of elimination (t1/2) of E3112
time frame: Days 1 to 4, 8, 14, and 28
description: t1/2 is the time required for the concentration of the drug to reach half of its original value.
measure: Clearance of E3112
time frame: Days 1 to 4, 8, 14, and 28
description: Clearance is defined as the rate of drug elimination divided by the plasma concentration of the drug.
measure: Volume of distribution (Vd) of E3112
time frame: Days 1 to 4, 8, 14, and 28
description: Vd is the theoretical volume that would be necessary to contain the total amount of an administered drug at the same concentration that it is observed in the blood plasma.
measure: Number of participants with any serious adverse event and any non-serious adverse event
time frame: Days 1 to 28
description: An adverse event is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A serious adverse event is defined as any adverse event occurring at any dose that results in any of the following outcomes: results in death; is life threatening; results in inpatient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life function; results in a congenital anomaly/birth defect; or can be defined as any other important medical event.
measure: Number of participants with an abnormal, clinically significant hematology parameter value
time frame: Days 1 to 28
description: Clinical significance will be determined by the investigator.
measure: Number of participants with an abnormal, clinically significant blood chemistry parameter value
time frame: Days 1 to 28
description: Clinical significance will be determined by the investigator.
measure: Number of participants with an abnormal, clinically significant urine value
time frame: Days 1 to 28
description: Clinical significance will be determined by the investigator.
measure: Number of participants with an abnormal, clinically significant vital sign measurement
time frame: Baseline; Days 1 to 28
description: Clinical significance will be determined by the investigator.
measure: Number of participants with an abnormal, clinically significant electrocardiogram (ECG) measurement
time frame: Baseline; Days 1 to 28
description: Clinical significance will be determined by the investigator.
measure: Number of participants with an abnormal, clinically significant physical examination measurement
time frame: Baseline; Days 1 to 28
description: Clinical significance will be determined by the investigator.
arm group label: Cohort 1: Placebo
arm group type: Placebo Comparator
description: Intravenous placebo infusion
arm group label: Cohort 1: E3112
arm group type: Experimental
description: Intravenous E3112 infusion
arm group label: Cohort 2: Placebo
arm group type: Placebo Comparator
description: Intravenous placebo infusion
arm group label: Cohort 2: E3112
arm group type: Experimental
description: Intravenous E3112 infusion
arm group label: Cohort 3: Placebo
arm group type: Placebo Comparator
description: Intravenous placebo infusion
arm group label: Cohort 3: E3112
arm group type: Experimental
description: Intravenous E3112 infusion
arm group label: Cohort 4: Placebo
arm group type: Placebo Comparator
description: Intravenous placebo infusion
arm group label: Cohort 4: E3112
arm group type: Experimental
description: Intravenous E3112 infusion
arm group label: Cohort 5: Placebo
arm group type: Placebo Comparator
description: Intravenous placebo infusion
arm group label: Cohort 5: E3112
arm group type: Experimental
description: Intravenous E3112 infusion
intervention type: Drug
intervention name: Placebo
description: Intravenous infusion
arm group label: Cohort 1: Placebo
arm group label: Cohort 2: Placebo
arm group label: Cohort 3: Placebo
arm group label: Cohort 4: Placebo
arm group label: Cohort 5: Placebo
intervention type: Drug
intervention name: E3112
description: Intravenous infusion
arm group label: Cohort 1: E3112
arm group label: Cohort 2: E3112
arm group label: Cohort 3: E3112
arm group label: Cohort 4: E3112
arm group label: Cohort 5: E3112
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 44 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Japan
responsible party type: Sponsor
sharing ipd: No