<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/NCT02972125</url>
  </required_header>
  <id_info>
    <org_study_id>EP0059</org_study_id>
    <secondary_id>2016-002462-31</secondary_id>
    <nct_id>NCT02972125</nct_id>
  </id_info>
  <brief_title>A Study to Demonstrate the Bioequivalence of Lacosamide Tablets and Dry Syrup in Healthy Male Japanese Subjects</brief_title>
  <official_title>A Single-Center, Open-Label, Randomized, Single-Oral Dose, 2-Way Cross-Over Study to Investigate the Bioequivalence Between Lacosamide Tablet and Dry Syrup in Healthy Male Japanese Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UCB Biopharma S.P.R.L.</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>
      This is a study designed to demonstrate the Bioequivalence between Lacosamide (LCM) Tablet&#xD;
      and Dry Syrup in Healthy Male Japanese Subjects&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</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>Maximum concentration (Cmax)</measure>
    <time_frame>Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the curve from 0 to time of last quantifiable concentration (AUC(0-t))</measure>
    <time_frame>Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the curve from zero up to infinity (AUC)</measure>
    <time_frame>Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent total body clearance (CL/F)</measure>
    <time_frame>Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution (Vz/F)</measure>
    <time_frame>Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time (MRT)</measure>
    <time_frame>Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of observed Cmax (tmax)</measure>
    <time_frame>Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal elimination half-life (t1/2)</measure>
    <time_frame>Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>First order terminal elimination rate constant (Lambda z)</measure>
    <time_frame>Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Treatment A - B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single administration of the reference drug (Treatment A, a single dose of Lacosamide (LCM) 100 mg tablet), followed by a Wash-Out Period of at least 7 days and a single administration of the test drug (Treatment B, a single dose of LCM 100 mg given as dry syrup).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment B - A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single administration of the test drug (Treatment B, a single dose of LCM 100 mg given as dry syrup), followed by a Wash-Out Period of at least 7 days and a single administration of the reference drug (Treatment A, a single dose of Lacosamide (LCM) 100 mg tablet).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lacosamide (LCM) tablet</intervention_name>
    <description>Treatment A: Single dose of Lacosamide (LCM) 100 mg tablet</description>
    <arm_group_label>Treatment A - B</arm_group_label>
    <arm_group_label>Treatment B - A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lacosamide (LCM) dry syrup</intervention_name>
    <description>Treatment B: Single dose of Lacosamide (LCM) 100 mg given as dry syrup</description>
    <arm_group_label>Treatment A - B</arm_group_label>
    <arm_group_label>Treatment B - A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is male and between 20 and 55 years of age (inclusive)&#xD;
&#xD;
          -  Subject is of Japanese descent as evidenced by appearance and verbal confirmation of&#xD;
             familial heritage (a subject has all 4 Japanese grandparents born in Japan)&#xD;
&#xD;
          -  Male subject confirms that when having sexual intercourse with a woman of childbearing&#xD;
             potential, he will use condoms during the study and 1 week after the last dose of&#xD;
             study drug&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has any medical or psychiatric condition that, in the opinion of the&#xD;
             investigator, could jeopardize or would compromise the subject's ability to&#xD;
             participate in this study.&#xD;
&#xD;
          -  Subject has clinically relevant out-of-range values for hematology, and serum&#xD;
             chemistry, or urinalysis variables at the Screening Visit.&#xD;
&#xD;
          -  Subject has any clinically significant abnormal physical examination (Screening Visit&#xD;
             or Day -1) and vital signs (Screening Visit).&#xD;
&#xD;
          -  Subject has any clinically relevant ECG finding at the Screening Visit.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>UCB Cares</last_name>
    <role>Study Director</role>
    <affiliation>+1 877 822 9493 (UCB)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ep0059 001</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>March 9, 2017</last_update_submitted>
  <last_update_submitted_qc>March 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lacosamide</keyword>
  <keyword>Bioequivalence</keyword>
  <keyword>Dry Syrup</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lacosamide</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/NCT02972125
org study id: EP0059
secondary id: 2016-002462-31
nct id: NCT02972125
lead sponsor: 
has dmc: No
This is a study designed to demonstrate the Bioequivalence between Lacosamide (LCM) Tablet
      and Dry Syrup in Healthy Male Japanese Subjects
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum concentration (Cmax)
time frame: Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing
measure: Area under the curve from 0 to time of last quantifiable concentration (AUC(0-t))
time frame: Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing
measure: Area under the curve from zero up to infinity (AUC)
time frame: Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing
measure: Apparent total body clearance (CL/F)
time frame: Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing
measure: Apparent volume of distribution (Vz/F)
time frame: Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing
measure: Mean residence time (MRT)
time frame: Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing
measure: Time of observed Cmax (tmax)
time frame: Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing
measure: Terminal elimination half-life (t1/2)
time frame: Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing
measure: First order terminal elimination rate constant (Lambda z)
time frame: Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing
arm group label: Treatment A - B
arm group type: Experimental
description: Single administration of the reference drug (Treatment A, a single dose of Lacosamide (LCM) 100 mg tablet), followed by a Wash-Out Period of at least 7 days and a single administration of the test drug (Treatment B, a single dose of LCM 100 mg given as dry syrup).
arm group label: Treatment B - A
arm group type: Experimental
description: Single administration of the test drug (Treatment B, a single dose of LCM 100 mg given as dry syrup), followed by a Wash-Out Period of at least 7 days and a single administration of the reference drug (Treatment A, a single dose of Lacosamide (LCM) 100 mg tablet).
intervention type: Drug
intervention name: Lacosamide (LCM) tablet
description: Treatment A: Single dose of Lacosamide (LCM) 100 mg tablet
arm group label: Treatment A - B
arm group label: Treatment B - A
intervention type: Drug
intervention name: Lacosamide (LCM) dry syrup
description: Treatment B: Single dose of Lacosamide (LCM) 100 mg given as dry syrup
arm group label: Treatment A - B
arm group label: Treatment B - A
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: UCB Cares
role: Study Director
affiliation: +1 877 822 9493 (UCB)
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Lacosamide