<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/NCT04401137</url>
  </required_header>
  <id_info>
    <org_study_id>QDX001</org_study_id>
    <nct_id>NCT04401137</nct_id>
  </id_info>
  <brief_title>The Evaluation of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of QDX in Healthy Korean Male Subjects</brief_title>
  <official_title>A Single Center, Randomized, Double Blind, Placebo Controlled, Dose Escalation Clinical Trial to Evaluate Pharmacokinetic/Pharmacodynamic Characteristics and Safety of QDX After Single Oral Administration in Healthy Korean Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SK Chemicals Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SK Chemicals Co., Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate pharmacokinetic/pharmacodynamic characteristics and safety of QDX after single&#xD;
      oral administration in healthy Korean male subjects&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">October 6, 2020</completion_date>
  <primary_completion_date type="Actual">October 6, 2020</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Capsaicin-Induced Dermal Blood Flow (DBF)</measure>
    <time_frame>Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 24 hour post-dosing on Day1</time_frame>
    <description>Change from Baseline in Dermal Blood Flow Induced by QDX Compared to Placebo</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-T])</measure>
    <time_frame>Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1</time_frame>
    <description>Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Plasma Concentration (AUClast)</measure>
    <time_frame>Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1</time_frame>
    <description>Area under the plasma concentration-time curve from time zero to the last quantifiable concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1</time_frame>
    <description>Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Reach Maximum Plasma Concentration (Tmax)</measure>
    <time_frame>Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1</time_frame>
    <description>Tmax was defined as the time required to reach maximum observed plasma concentration.</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Migraine</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>QDX 25</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>QDX 50</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>QDX 100</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>QDX 200</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topiramate</intervention_name>
    <description>Topiramate</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>QDX 100</arm_group_label>
    <arm_group_label>QDX 200</arm_group_label>
    <arm_group_label>QDX 25</arm_group_label>
    <arm_group_label>QDX 50</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants who have fully understood this clinical trial via detailed explanation,&#xD;
             are willing to voluntarily participate in this study, and agree to give written&#xD;
             informed consent which is confirmed from IRB.&#xD;
&#xD;
          -  Healthy male participants aged between 19 and 45 years at screening&#xD;
&#xD;
          -  Those whose body weight is over 50kg, and BMI is between 18.0 and 27.0&#xD;
&#xD;
          -  Participants who have demonstrated at least a 100 percent (%) increase in dermal blood&#xD;
             flow in 30 minutes after capsaicin challenge as part of the screening procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those who have a clinically significant disease of liver, kidney, digestive,&#xD;
             respiratory, endocrine, neurologic, blood/tumor, cardiovascular system, or history of&#xD;
             those diseases&#xD;
&#xD;
          -  Those who have a history of hypersensitivity or clinically significant&#xD;
             hypersensitivity reactions to drugs (containing Topiramate etc.)&#xD;
&#xD;
          -  Those who have a hereditary galactose intolerance, lapp lactase deficiency or&#xD;
             glucose-galactose malabsorption syndrome&#xD;
&#xD;
          -  Those who have irritating skin, wounds, eczema, and wounds on the area where capsaicin&#xD;
             is applied&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Hospital, Dept. of Clinical Pharmacology</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>October 23, 2020</last_update_submitted>
  <last_update_submitted_qc>October 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Topiramate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04401137
org study id: QDX001
nct id: NCT04401137
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To evaluate pharmacokinetic/pharmacodynamic characteristics and safety of QDX after single
      oral administration in healthy Korean male subjects
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: The Capsaicin-Induced Dermal Blood Flow (DBF)
time frame: Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 24 hour post-dosing on Day1
description: Change from Baseline in Dermal Blood Flow Induced by QDX Compared to Placebo
measure: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-T])
time frame: Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1
description: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.
measure: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Plasma Concentration (AUClast)
time frame: Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1
description: Area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1
description: Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data.
measure: Time to Reach Maximum Plasma Concentration (Tmax)
time frame: Pre-dose(-2 hour), 2 hour, 4 hour, 8 hour, 12hour, 24 hour post-dosing on Day1
description: Tmax was defined as the time required to reach maximum observed plasma concentration.
arm group label: Placebo
arm group type: Placebo Comparator
arm group label: QDX 25
arm group type: Experimental
arm group label: QDX 50
arm group type: Experimental
arm group label: QDX 100
arm group type: Experimental
arm group label: QDX 200
arm group type: Experimental
intervention type: Drug
intervention name: Topiramate
description: Topiramate
arm group label: Placebo
arm group label: QDX 100
arm group label: QDX 200
arm group label: QDX 25
arm group label: QDX 50
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Topiramate
sharing ipd: Undecided