<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/NCT01725009</url>
  </required_header>
  <id_info>
    <org_study_id>EP0038</org_study_id>
    <nct_id>NCT01725009</nct_id>
  </id_info>
  <brief_title>Multiple-dose Study of Levetiracetam Injection in Japanese and Caucasian Healthy Males</brief_title>
  <official_title>A Single-center, Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Levetiracetam Administered as Intravenous Infusion in Japanese and Caucasian Healthy Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UCB Japan Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UCB Pharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the pharmacokinetics of levetiracetam following single and multiple 15-minute&#xD;
      intravenous infusions of 1500 mg levetiracetam between Japanese and Caucasian healthy male&#xD;
      subjects&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2012</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>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum plasma concentration after a single dose (Cmax)</measure>
    <time_frame>Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of Intravenous (IV) infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the curve from zero to the time of the last quantifiable concentration after a single (AUC(0-t))</measure>
    <time_frame>Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration time curve from zero to infinity after a single dose (AUC)</measure>
    <time_frame>Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Body-weight normalized maximum plasma concentration after a single dose (Cmax)</measure>
    <time_frame>Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Body-weight normalized area under the curve from zero to the time of the last quantifiable concentration after a single, (AUC(0-t))</measure>
    <time_frame>Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Body weight normalized area under the plasma concentration time curve from zero to infinity after a single dose, (AUC)</measure>
    <time_frame>Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum plasma concentration at steady state after multiple doses (Cmax,ss)</measure>
    <time_frame>Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the curve over a dosing interval at steady state after multiple doses (AUCτss)</measure>
    <time_frame>Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Body-weight normalized maximum plasma concentration at steady state after multiple doses (Cmax,ss)</measure>
    <time_frame>Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Body-weight normalized area under the curve over a dosing interval at steady state after multiple doses (AUCτss)</measure>
    <time_frame>Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the curve over a dosing interval, (AUCτ (τ = 12 hours))</measure>
    <time_frame>Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum plasma concentration after a single dose (tmax)</measure>
    <time_frame>Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal elimination half-life after a single dose (t1/2)</measure>
    <time_frame>Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>First order terminal elimination rate constant after a single dose (λz)</measure>
    <time_frame>Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total body clearance after a single dose (CL)</measure>
    <time_frame>Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of distribution during terminal phase after a single dose (Vz)</measure>
    <time_frame>Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time after a single dose (MRT)</measure>
    <time_frame>Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum plasma concentration at steady state after multiple doses (tmax,ss)</measure>
    <time_frame>Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total body clearance at steady state after multiple doses (CLss)</measure>
    <time_frame>Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linearity factor after multiple doses (LF)</measure>
    <time_frame>Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of the first IV infusion and at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of the last IV infusion.</time_frame>
    <description>LF = AUCτss / AUC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation ratio (RAUC) after multiple doses</measure>
    <time_frame>Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of the first and the last IV infusions</time_frame>
    <description>RAUC = AUCτss / AUCτ</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Levetiracetam IV infusions in Japanese</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multiple 15-minute intravenous infusions of 1500 mg levetiracetam in Japanese subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Levetiracetam IV infusions in Caucasian</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multiple 15-minute intravenous infusions of 1500 mg levetiracetam in Caucasian subjects</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Multiple 15-minute intravenous infusions of 1500 mg levetiracetam</intervention_name>
    <description>Strength, 100 mg/mL; Form, concentrate for solution for infusion; Frequency, twice a day; Duration, 7 days</description>
    <arm_group_label>Levetiracetam IV infusions in Caucasian</arm_group_label>
    <arm_group_label>Levetiracetam IV infusions in Japanese</arm_group_label>
    <other_name>E-Keppra</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy Japanese and Caucasian males with the age between 20 and 40 years old,&#xD;
&#xD;
          -  with the body mass index between 20 and 25,&#xD;
&#xD;
          -  with the body weight between 60 and 80kg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects who have a history or presence of drug addiction or excessive use of alcohol&#xD;
&#xD;
          -  current smokers and former smokers who have given up since less than 6 months before&#xD;
             the first dose&#xD;
&#xD;
          -  heavy caffeine drinker&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>01</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>March 2013</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>March 27, 2013</last_update_submitted>
  <last_update_submitted_qc>March 27, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 29, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy volunteers</keyword>
  <keyword>Japanese</keyword>
  <keyword>Caucasian</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Levetiracetam</mesh_term>
  </intervention_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/NCT01725009
org study id: EP0038
nct id: NCT01725009
lead sponsor: 
has dmc: No
To compare the pharmacokinetics of levetiracetam following single and multiple 15-minute
      intravenous infusions of 1500 mg levetiracetam between Japanese and Caucasian healthy male
      subjects
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Maximum plasma concentration after a single dose (Cmax)
time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of Intravenous (IV) infusion
measure: Area under the curve from zero to the time of the last quantifiable concentration after a single (AUC(0-t))
time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion
measure: Area under the plasma concentration time curve from zero to infinity after a single dose (AUC)
time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion
measure: Body-weight normalized maximum plasma concentration after a single dose (Cmax)
time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion
measure: Body-weight normalized area under the curve from zero to the time of the last quantifiable concentration after a single, (AUC(0-t))
time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion
measure: Body weight normalized area under the plasma concentration time curve from zero to infinity after a single dose, (AUC)
time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion
measure: Maximum plasma concentration at steady state after multiple doses (Cmax,ss)
time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.
measure: Area under the curve over a dosing interval at steady state after multiple doses (AUCτss)
time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.
measure: Body-weight normalized maximum plasma concentration at steady state after multiple doses (Cmax,ss)
time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.
measure: Body-weight normalized area under the curve over a dosing interval at steady state after multiple doses (AUCτss)
time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.
measure: Area under the curve over a dosing interval, (AUCτ (τ = 12 hours))
time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion
measure: Time to maximum plasma concentration after a single dose (tmax)
time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.
measure: Terminal elimination half-life after a single dose (t1/2)
time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.
measure: First order terminal elimination rate constant after a single dose (λz)
time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.
measure: Total body clearance after a single dose (CL)
time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.
measure: Volume of distribution during terminal phase after a single dose (Vz)
time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.
measure: Mean residence time after a single dose (MRT)
time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.
measure: Time to maximum plasma concentration at steady state after multiple doses (tmax,ss)
time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.
measure: Total body clearance at steady state after multiple doses (CLss)
time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.
measure: Linearity factor after multiple doses (LF)
time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of the first IV infusion and at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of the last IV infusion.
description: LF = AUCτss / AUC
measure: Accumulation ratio (RAUC) after multiple doses
time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of the first and the last IV infusions
description: RAUC = AUCτss / AUCτ
arm group label: Levetiracetam IV infusions in Japanese
arm group type: Experimental
description: Multiple 15-minute intravenous infusions of 1500 mg levetiracetam in Japanese subjects
arm group label: Levetiracetam IV infusions in Caucasian
arm group type: Experimental
description: Multiple 15-minute intravenous infusions of 1500 mg levetiracetam in Caucasian subjects
intervention type: Drug
intervention name: Multiple 15-minute intravenous infusions of 1500 mg levetiracetam
description: Strength, 100 mg/mL; Form, concentrate for solution for infusion; Frequency, twice a day; Duration, 7 days
arm group label: Levetiracetam IV infusions in Caucasian
arm group label: Levetiracetam IV infusions in Japanese
other name: E-Keppra
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Levetiracetam