<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/NCT03814642</url>
  </required_header>
  <id_info>
    <org_study_id>CJ_APA_110</org_study_id>
    <nct_id>NCT03814642</nct_id>
  </id_info>
  <brief_title>Effect of Tegoprazan on Pharmacodynamics of Clopidogrel in Healthy Male Participants</brief_title>
  <official_title>A Randomized, Open-label, Three-period, Multiple Dosing Crossover Clinical Trial to Evaluate the Influence of Tegoprazan on the Pharmacodynamics of Clopidogrel According to CYP2C19 Genotypes in Healthy Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HK inno.N Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HK inno.N Corporation</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>
      This study aims to evaluate the influence of tegoprazan on the pharmacodynamics of&#xD;
      clopidogrel according to CYP2C19 genotypes following co-administration of tegoprazan and&#xD;
      clopidogrel in healthy male volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evaluation Criteria:&#xD;
&#xD;
        -  Pharmacodynamic assessments using P2Y12 assay&#xD;
&#xD;
        -  Safety assessments with adverse event monitoring including subjective/objective&#xD;
           symptoms, physical examination, vital signs, electrocardiogram, and laboratory test&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 21, 2019</start_date>
  <completion_date type="Actual">July 22, 2019</completion_date>
  <primary_completion_date type="Actual">July 22, 2019</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>Change in P2Y12 Reaction Unit (PRU) from baseline</measure>
    <time_frame>Pre-dose(0h) on days 1, 3, 5, and 8 in each period</time_frame>
    <description>Pharmacodynamic blood sampling to measure PRU using VerifyNow® system</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Clopidogrel 75 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oral administration of clopidogrel 75 mg tablet once daily for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clopidogrel 75 mg + Tegoprazan 50 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral administration of clopidogrel 75 mg tablet and tegoprazan 50 mg tablet once daily for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clopidogrel 75 mg + Esomeprazole 20 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral administration of clopidogrel 75 mg tablet and esomeprazole 20 mg tablet once daily for 7 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clopidogrel 75 mg</intervention_name>
    <description>Clopidogrel 75 mg tablet</description>
    <arm_group_label>Clopidogrel 75 mg</arm_group_label>
    <arm_group_label>Clopidogrel 75 mg + Esomeprazole 20 mg</arm_group_label>
    <arm_group_label>Clopidogrel 75 mg + Tegoprazan 50 mg</arm_group_label>
    <other_name>Plavix</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tegoprazan 50 mg</intervention_name>
    <description>Tegoprazan 50 mg tablet</description>
    <arm_group_label>Clopidogrel 75 mg + Tegoprazan 50 mg</arm_group_label>
    <other_name>K-CAB</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Esomeprazole 20 mg</intervention_name>
    <description>Esomeprazole 20 mg tablet</description>
    <arm_group_label>Clopidogrel 75 mg + Esomeprazole 20 mg</arm_group_label>
    <other_name>Nexium</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adult males aged ≥ 19 years and ≤ 50 years on the date of the written informed&#xD;
             consent&#xD;
&#xD;
          -  Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 18.0 kg/m2 and&#xD;
             ≤ 27.0 kg/m2 at the time of screening&#xD;
&#xD;
          -  Helicobacter pylori negative&#xD;
&#xD;
          -  Voluntarily decided to participate in the study and provided written informed consent&#xD;
             before any screening procedure&#xD;
&#xD;
          -  Judged by the investigator to be eligible for this study based on physical&#xD;
             examination, laboratory test, inquiry, etc.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a history of or currently has clinically significant liver, kidney, nervous&#xD;
             system, respiratory system, endocrine system, blood, cardiovascular system, urinary&#xD;
             system, or psychiatric disease or tumor&#xD;
&#xD;
          -  Has a history of or currently has gastrointestinal disorder (gastrointestinal ulcer,&#xD;
             gastritis, stomach cramps, gastroesophageal reflux disease, Crohn's disease, etc.)&#xD;
             that may influence the safety and pharmacodynamic assessments of the investigational&#xD;
             product&#xD;
&#xD;
          -  Has a history of gastrointestinal surgery (except simple appendectomy and hernia&#xD;
             surgery)&#xD;
&#xD;
          -  Hypersensitivity to drugs including the ingredients of the investigational product and&#xD;
             other drugs (aspirin, antibiotics, etc.) or a history of clinically significant&#xD;
             hypersensitivity&#xD;
&#xD;
          -  Positive serological test including hepatitis B, hepatitis C, or human&#xD;
             immunodeficiency virus (HIV)&#xD;
&#xD;
          -  Blood total bilirubin, AST (GOT), and ALT (GPT) levels greater than 1.5x of the upper&#xD;
             limit of normal range at screening&#xD;
&#xD;
          -  Platelet, PT and aPTT levels outside the upper/lower limit of normal range by 10% at&#xD;
             screening&#xD;
&#xD;
          -  P2Y12 Reaction Unit (PRU) by P2Y12 assay outside the upper/lower limit of normal range&#xD;
             by 10% at screening&#xD;
&#xD;
          -  *17 allele by CYP2C19 genotyping (Ultrarapid metabolizer)&#xD;
&#xD;
          -  Systolic blood pressure &lt; 90 mmHg or &gt; 140 mmHg, diastolic blood pressure &lt; 50 mmHg or&#xD;
             &gt; 95 mmHg, or pulse rate &lt; 45 beats/minute or &gt; 100 beats/minute when vital signs are&#xD;
             measured in sitting position after resting for at least 5 minutes during screening&#xD;
&#xD;
          -  QTc &gt; 450 msec, PR interval &gt; 200 msec, QRS interval &gt; 120 msec, and other clinically&#xD;
             significant findings on electrocardiogram at screening&#xD;
&#xD;
          -  Has a history of or positive urine screening for drug abuse&#xD;
&#xD;
          -  Administration of any prescription drugs or herbal medicine within 2 weeks prior to&#xD;
             the expected date of the first dose, or administration of any over-the-counter (OTC)&#xD;
             drug, health functional food or vitamin within 1 week prior to the expected date of&#xD;
             the first dose (However, can participate in the study if otherwise decided eligible by&#xD;
             the investigator)&#xD;
&#xD;
          -  Participation in other clinical study or bioequivalence study to receive an&#xD;
             investigational product within 3 months prior to the expected date of the first dose&#xD;
&#xD;
          -  Donation of whole blood within 2 months or apheresis/receipt of blood transfusion&#xD;
             within 1 month prior to the expected date of the first dose&#xD;
&#xD;
          -  Excessive caffeine intake (&gt; 5 units/day) or persistent alcohol intake (&gt; 21&#xD;
             units/week, 1 unit = 10 g of pure alcohol), or inability to abstain from drinking&#xD;
             during hospitalization period&#xD;
&#xD;
          -  Smoking for more than 3 months prior to the study or inability to cease smoking&#xD;
             throughout the study&#xD;
&#xD;
          -  Inability to refrain from grapefruit-containing food from 24 hours before admission to&#xD;
             discharge&#xD;
&#xD;
          -  Inability to refrain from caffeine-containing food (coffee, tea (black tea, green tea,&#xD;
             etc.), carbonated drink, coffee-flavored milk, nutritional tonic, etc.) from 24 hours&#xD;
             before admission to discharge&#xD;
&#xD;
          -  Inability to use a medically acceptable method of contraception throughout the study.&#xD;
             Medically acceptable methods of contraception include use of intrauterine device with&#xD;
             established failure rate of contraception by spouse (or partner), concomitant use of&#xD;
             barrier method (for male or for female) and spermicide, or surgical procedure on&#xD;
             subject himself or his partner (vasectomy, tubal resection/ligation, hysterectomy)&#xD;
&#xD;
          -  Considered ineligible to participate in the study by the investigator based on&#xD;
             laboratory test results or other reasons&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>In-Jin Jang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital, Dept. of Clinical Pharmacology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital, Clinical Trial Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>January 20, 2019</study_first_submitted>
  <study_first_submitted_qc>January 20, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>October 18, 2019</last_update_submitted>
  <last_update_submitted_qc>October 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2019</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>Esomeprazole</mesh_term>
    <mesh_term>Clopidogrel</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/NCT03814642
org study id: CJ_APA_110
nct id: NCT03814642
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate the influence of tegoprazan on the pharmacodynamics of
      clopidogrel according to CYP2C19 genotypes following co-administration of tegoprazan and
      clopidogrel in healthy male volunteers.
Evaluation Criteria:

        -  Pharmacodynamic assessments using P2Y12 assay

        -  Safety assessments with adverse event monitoring including subjective/objective
           symptoms, physical examination, vital signs, electrocardiogram, and laboratory test
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in P2Y12 Reaction Unit (PRU) from baseline
time frame: Pre-dose(0h) on days 1, 3, 5, and 8 in each period
description: Pharmacodynamic blood sampling to measure PRU using VerifyNow® system
arm group label: Clopidogrel 75 mg
arm group type: Active Comparator
description: Oral administration of clopidogrel 75 mg tablet once daily for 7 days
arm group label: Clopidogrel 75 mg + Tegoprazan 50 mg
arm group type: Experimental
description: Oral administration of clopidogrel 75 mg tablet and tegoprazan 50 mg tablet once daily for 7 days
arm group label: Clopidogrel 75 mg + Esomeprazole 20 mg
arm group type: Experimental
description: Oral administration of clopidogrel 75 mg tablet and esomeprazole 20 mg tablet once daily for 7 days
intervention type: Drug
intervention name: Clopidogrel 75 mg
description: Clopidogrel 75 mg tablet
arm group label: Clopidogrel 75 mg
arm group label: Clopidogrel 75 mg + Esomeprazole 20 mg
arm group label: Clopidogrel 75 mg + Tegoprazan 50 mg
other name: Plavix
intervention type: Drug
intervention name: Tegoprazan 50 mg
description: Tegoprazan 50 mg tablet
arm group label: Clopidogrel 75 mg + Tegoprazan 50 mg
other name: K-CAB
intervention type: Drug
intervention name: Esomeprazole 20 mg
description: Esomeprazole 20 mg tablet
arm group label: Clopidogrel 75 mg + Esomeprazole 20 mg
other name: Nexium
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: In-Jin Jang
role: Principal Investigator
affiliation: Seoul National University Hospital, Dept. of Clinical Pharmacology
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Esomeprazole
mesh term: Clopidogrel