<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/NCT03009760</url>
  </required_header>
  <id_info>
    <org_study_id>[CJ_APA_104]</org_study_id>
    <nct_id>NCT03009760</nct_id>
  </id_info>
  <brief_title>To Investigate Pharmacokinetics and Pharmacodynamics of CJ-12420 After Single and Multiple Dose Administration</brief_title>
  <official_title>A Phase I , Study to Investigate Pharmacokinetics and Pharmacodynamics of Single and Multiple Dose of CJ-12420 50mg, 100mg in Helicobacter Pylori ?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HK inno.N Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>HK inno.N Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of CJ-12420&#xD;
      after single and multiple dose administration according to H. pylori infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Cohort 1: To investigate the pharmacokinetics and pharmacodynamics of CJ-12420 after the&#xD;
           multiple dose administration in H. pylori negative volunteers.&#xD;
&#xD;
        2. Cohort 2: To investigate the pharmacokinetics and pharmacodynamics of CJ-12420 after the&#xD;
           single dose administration in H. pylori positive volunteers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peak Plasma Concentration (Cmax) of CJ-12420</measure>
    <time_frame>up to 12 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC) of CJ-12420</measure>
    <time_frame>up to 12 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of maximum observed concentration(tmax) of CJ-12420</measure>
    <time_frame>up to 12 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Half life(t1/2β) of CJ-12420</measure>
    <time_frame>up to 12 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean pH</measure>
    <time_frame>Day -1, Day 1, Day 7 up to 24 hours</time_frame>
    <description>Data from the pH probe monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time at pH &gt; 4(%)</measure>
    <time_frame>Day -1, Day 1, Day 7 up to 24 hours</time_frame>
    <description>the percent of time the pH as data from the pH probe monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time at pH &gt; 6(%)</measure>
    <time_frame>Day -1, Day 1, Day 7 up to 24 hours</time_frame>
    <description>the percent of time the pH as data from the pH probe monitoring</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>CJ-12420 50mg(HP-)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CJ-12420 50mg in H. pylori negative subject</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CJ-12420 100mg(HP-)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CJ-12420 100mg in H. pylori negative subject</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CJ-12420 50mg(HP+)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CJ-12420 50mg in H. pylori positive subject</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CJ-12420 100mg(HP+)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CJ-12420 100mg in H. pylori positive subject</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CJ-12420 50mg(HP-)</intervention_name>
    <description>CJ-12420 50mg in H. pylori negative subject</description>
    <arm_group_label>CJ-12420 50mg(HP-)</arm_group_label>
    <other_name>not yet determined</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CJ-12420 100mg(HP-)</intervention_name>
    <description>CJ-12420 100mg in H. pylori negative subject</description>
    <arm_group_label>CJ-12420 100mg(HP-)</arm_group_label>
    <other_name>not yet determined</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CJ-12420 50mg(HP+)</intervention_name>
    <description>CJ-12420 50mg in H. pylori positive subject</description>
    <arm_group_label>CJ-12420 50mg(HP+)</arm_group_label>
    <other_name>not yet determined</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CJ-12420 100mg(HP+)</intervention_name>
    <description>CJ-12420 100mg in H. pylori positive subject</description>
    <arm_group_label>CJ-12420 100mg(HP+)</arm_group_label>
    <other_name>not yet determined</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male volunteers between 20 to 45 years of age (inclusive)&#xD;
&#xD;
          -  Body mass index (BMI) in the range of 19~28 kg/㎡ and weighted at least 50kg&#xD;
&#xD;
          -  Medically healthy with no clinically significant vital signs (blood pressure in the&#xD;
             sitting position, pulse rate)&#xD;
&#xD;
               -  90 mmHg ≤ systolic blood pressure ≤ 140 mmHg&#xD;
&#xD;
               -  50 mmHg ≤ diastolic blood pressure ≤ 95 mmHg&#xD;
&#xD;
               -  45 beats per minute ≤ pulse rate ≤ 95 beats per minute&#xD;
&#xD;
          -  Understood the requirements of the study and voluntarily consented to participate in&#xD;
             the study&#xD;
&#xD;
          -  Agreed to be sexually abstinent or to use a condom or spermicide when engaging in&#xD;
             sexual activity and not to donate sperm during the course of the study for 30 days&#xD;
             following completion of the study&#xD;
&#xD;
          -  Non-smokers or non-users of nicotine-containing products for at least 1 year&#xD;
&#xD;
          -  [Cohort 1] H. pylori negative as determined by urea breath test and serum IgG antibody&#xD;
&#xD;
          -  [Cohort 2] H. pylori positive as determined by urea breath test and serum IgG&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of clinically significant gastrointestinal, renal, hepatic, neurologic,&#xD;
             hemato-oncologic, endocrine, pulmonary, immunologic, psychiatric, musculoskeletal, or&#xD;
             cardiovascular disease or any other condition, which in the opinion of the&#xD;
             investigators, would jeopardize the safety of the subject or impact the validity of&#xD;
             the study results&#xD;
&#xD;
          -  History of allergy or hypersensitivity to any drug, including prior serious adverse&#xD;
             reaction to PPIs or P-CABs&#xD;
&#xD;
          -  Undergone surgery or in a medical condition, which in the judgment of the PI or&#xD;
             investigators may affect absorption, distribution, metabolism or elimination of the&#xD;
             study drug&#xD;
&#xD;
          -  Administered other drug(s) in other clinical study within 60 days prior to screening&#xD;
             visit&#xD;
&#xD;
          -  Donated blood within 60 days or blood components within 30 days, or had been&#xD;
             transfused plasma within 30 days prior to screening visit&#xD;
&#xD;
          -  On special diet or have experienced substantial changes in eating habits within 30&#xD;
             days prior to screening visit&#xD;
&#xD;
          -  Used any prescription medication within 14 days, or any other OTC medications&#xD;
             including herbal products within 7 days prior to screening visit&#xD;
&#xD;
          -  Consumed over 21 units/week of alcohol&#xD;
&#xD;
          -  Consumed over 5 units/day of caffeine-containing beverage&#xD;
&#xD;
          -  Positive urine screen for drugs and/or cotinine&#xD;
&#xD;
          -  Positive blood screen for human immunodeficiency virus (HIV), hepatitis B or C, or&#xD;
             syphilis&#xD;
&#xD;
          -  Clinically significant abnormalities of liver function tests (≥1.5 fold of normal&#xD;
             upper limit in the level of L-alanine aminotransferase (ALT), L-aspartate&#xD;
             aminotransferase (AST) or total bilirubin)&#xD;
&#xD;
          -  Unable to bear pH meter catheter insertion&#xD;
&#xD;
          -  History of symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer,&#xD;
             Barrett's esophagus, or Zollinger-Ellison syndrome&#xD;
&#xD;
          -  Clinically significant observations considered as unsuitable based on medical judgment&#xD;
             by investigators&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>January 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>January 19, 2017</last_update_submitted>
  <last_update_submitted_qc>January 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03009760
org study id: [CJ_APA_104]
nct id: NCT03009760
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of CJ-12420
      after single and multiple dose administration according to H. pylori infection.
1. Cohort 1: To investigate the pharmacokinetics and pharmacodynamics of CJ-12420 after the
           multiple dose administration in H. pylori negative volunteers.

        2. Cohort 2: To investigate the pharmacokinetics and pharmacodynamics of CJ-12420 after the
           single dose administration in H. pylori positive volunteers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Peak Plasma Concentration (Cmax) of CJ-12420
time frame: up to 12 hours
measure: Area under the plasma concentration versus time curve (AUC) of CJ-12420
time frame: up to 12 hours
measure: Time of maximum observed concentration(tmax) of CJ-12420
time frame: up to 12 hours
measure: Half life(t1/2β) of CJ-12420
time frame: up to 12 hours
measure: Mean pH
time frame: Day -1, Day 1, Day 7 up to 24 hours
description: Data from the pH probe monitoring
measure: Time at pH > 4(%)
time frame: Day -1, Day 1, Day 7 up to 24 hours
description: the percent of time the pH as data from the pH probe monitoring
measure: Time at pH > 6(%)
time frame: Day -1, Day 1, Day 7 up to 24 hours
description: the percent of time the pH as data from the pH probe monitoring
arm group label: CJ-12420 50mg(HP-)
arm group type: Experimental
description: CJ-12420 50mg in H. pylori negative subject
arm group label: CJ-12420 100mg(HP-)
arm group type: Experimental
description: CJ-12420 100mg in H. pylori negative subject
arm group label: CJ-12420 50mg(HP+)
arm group type: Experimental
description: CJ-12420 50mg in H. pylori positive subject
arm group label: CJ-12420 100mg(HP+)
arm group type: Experimental
description: CJ-12420 100mg in H. pylori positive subject
intervention type: Drug
intervention name: CJ-12420 50mg(HP-)
description: CJ-12420 50mg in H. pylori negative subject
arm group label: CJ-12420 50mg(HP-)
other name: not yet determined
intervention type: Drug
intervention name: CJ-12420 100mg(HP-)
description: CJ-12420 100mg in H. pylori negative subject
arm group label: CJ-12420 100mg(HP-)
other name: not yet determined
intervention type: Drug
intervention name: CJ-12420 50mg(HP+)
description: CJ-12420 50mg in H. pylori positive subject
arm group label: CJ-12420 50mg(HP+)
other name: not yet determined
intervention type: Drug
intervention name: CJ-12420 100mg(HP+)
description: CJ-12420 100mg in H. pylori positive subject
arm group label: CJ-12420 100mg(HP+)
other name: not yet determined
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
sharing ipd: No