<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/NCT03043521</url>
  </required_header>
  <id_info>
    <org_study_id>CJ_APA_105</org_study_id>
    <nct_id>NCT03043521</nct_id>
  </id_info>
  <brief_title>Pharmacodynamic Properties of CJ-12420 on Evening Dosing</brief_title>
  <official_title>Phase I Study to Investigate Pharmacodynamics of CJ-12420 Compared to Dexlansoprazole With Evening Dosing</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>
      The purpose of this study is to compare and evaluate impact on pharmacodynamic&#xD;
      characteristics of CJ-12420 and dexlansoprazole with evening dosing in healthy male&#xD;
      volunteers&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evaluation Criteria:&#xD;
&#xD;
        1. Pharmacokinetic Endpoints Cmax, tmax, AUClast of CJ-12420&#xD;
&#xD;
        2. Pharmacodynamics Endpoints Time pH &gt; 4 Time pH &gt; 6 Integrated acidity Percent inhibition&#xD;
           of integrated acidity Percent inhibition time gastric pH ≤ 4 Median pH&#xD;
&#xD;
        3. Safety Assessments Physical examination, ECGs, vital signs (blood pressure, heart rate,&#xD;
           body temperature), laboratory test (CBC, Chemistry, UA), and adverse events (AEs)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 13, 2015</start_date>
  <completion_date type="Actual">August 12, 2015</completion_date>
  <primary_completion_date type="Actual">August 12, 2015</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>Time pH &gt; 4 of CJ-12420</measure>
    <time_frame>24 hours pH</time_frame>
    <description>intragastric pH</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax of CJ-12420</measure>
    <time_frame>up to 20 hours</time_frame>
    <description>maximum measured plasma concentraion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUClast of CJ-12420</measure>
    <time_frame>up to 20 hours</time_frame>
    <description>The area under the plasma concentration versus time curve from time 0 to the last measurable concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax of dexlansoprazole</measure>
    <time_frame>up to 20 hours</time_frame>
    <description>maximum measured plasma concentraion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUClast of dexlansoprazole</measure>
    <time_frame>up to 20 hours</time_frame>
    <description>The area under the plasma concentration versus time curve from time 0 to the last measurable concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time pH &gt; 4 of dexlansoprazole</measure>
    <time_frame>24 hours pH</time_frame>
    <description>intragastric pH</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median pH &gt; 4 of CJ-12420</measure>
    <time_frame>24 hours pH</time_frame>
    <description>intragastric pH</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median pH &gt; 4 of dexlansoprazole</measure>
    <time_frame>24 hours pH</time_frame>
    <description>intragastric pH</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>CJ-12420 50mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>T1=CJ-12420 50mg QD evening (9PM)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CJ-12420 100mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>T2=CJ-12420 100mg QD evening (9PM)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CJ-12420 200mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>T3=CJ-12420 200mg QD evening (9PM)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexlansopazole 60mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>R=dexlansoprazole 60mg QD evening (9p.m)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexlansoprazole 60 MG</intervention_name>
    <arm_group_label>Dexlansopazole 60mg</arm_group_label>
    <other_name>R</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CJ-12420 50mg</intervention_name>
    <arm_group_label>CJ-12420 50mg</arm_group_label>
    <other_name>T1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CJ-12420 100mg</intervention_name>
    <arm_group_label>CJ-12420 100mg</arm_group_label>
    <other_name>T2</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CJ-12420 200mg</intervention_name>
    <arm_group_label>CJ-12420 200mg</arm_group_label>
    <other_name>T3</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male volunteers aged ≥20 to ≤45 years&#xD;
&#xD;
          2. Body mass Index (BMI) of 19 to 28kg/m2 ; and a total body weight ≥ 50kg&#xD;
&#xD;
          3. Medically healthy without clinically significant vital signs (blood pressure in&#xD;
             sitting position, heart rate)&#xD;
&#xD;
               -  90 mmHg ≤ Systolic blood pressure (SBP) ≤ 140 mmHg&#xD;
&#xD;
               -  50 mmHg ≤ Diastolic blood pressure (DBP) ≤ 95 mmHg&#xD;
&#xD;
               -  45 (beats/min) ≤ Heart rate ≤ 95 (beats/min)&#xD;
&#xD;
          4. Understand restriction during the study and voluntarily consent to participate in the&#xD;
             study&#xD;
&#xD;
          5. Consent to use the effective contraceptive methods (using abstinence, spermicide, and&#xD;
             condom) and not to donate sperm during the study and until 30 days after completion of&#xD;
             study&#xD;
&#xD;
          6. Non-smoker or ex-smoker who stopped smoking for at least one year&#xD;
&#xD;
          7. Negative H. pylori result in urea breath test (UBT)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of clinically significant diseases in the digestive, kidney, liver, nervous,&#xD;
             hemato-oncologic, endocrine, respiratory, immune, psychiatric, musculoskeletal, or&#xD;
             cardiovascular system and other diseases that may harm safety of the subject or may&#xD;
             affect the validity of study results, in the judgment of investigator&#xD;
&#xD;
          2. History of allergy or hypersensitivity to any drugs including serious adverse events&#xD;
             from treatments such as PPI (omeprazole, rabeprazole, lansoprazole) or P-CAB&#xD;
&#xD;
          3. History surgery that may affect absorption, distribution, metabolism, and elimination&#xD;
             of the study drug or in such a medical condition, at the discretion of the principal&#xD;
             investigator or sub-investigator&#xD;
&#xD;
          4. History of use of another investigational product within 90 days prior to screening&#xD;
             visit&#xD;
&#xD;
          5. Donation of a unit of whole blood within 60 days or blood components or transfusion&#xD;
             within 30 days prior to screening visit&#xD;
&#xD;
          6. Having special diet or changes in dietary habits within 30 days prior to screening&#xD;
             visit&#xD;
&#xD;
          7. Use of prescription drug within 14 days or over-the-count (OTC) drug including herbal&#xD;
             medicine within 7 days prior to screening visit&#xD;
&#xD;
          8. Alcohol &gt; 21 units/week&#xD;
&#xD;
          9. Caffeinated drink intake &gt; 5units/day&#xD;
&#xD;
         10. Positive on urinary drug screening test or urine nicotine test&#xD;
&#xD;
         11. Positive human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or syphilis&#xD;
             test&#xD;
&#xD;
         12. Clinically significant abnormal result of liver function (serum ALT, AST or total&#xD;
             bilirubin levels ≥ 1.5 times the upper limit of normal (ULN))&#xD;
&#xD;
         13. Inability to tolerate pH catheter insertion&#xD;
&#xD;
         14. History of symptomatic GERD, erosive esophagitis (EE), duodenal ulcer, gastric ulcer,&#xD;
             Barrett's esophagus, or Zollinger-Ellison Syndrome&#xD;
&#xD;
         15. Any other conditions which would have made the subject unsuitable for the study in the&#xD;
             opinion of the investigator&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Healthy male volunteers</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eunji Kim</last_name>
    <role>Study Director</role>
    <affiliation>CJ HealthCare Corp.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asan Medical 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>February 2017</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>February 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>February 3, 2017</last_update_submitted>
  <last_update_submitted_qc>February 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 6, 2017</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>Dexlansoprazole</mesh_term>
    <mesh_term>Lansoprazole</mesh_term>
  </intervention_browse>
  <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/NCT03043521
org study id: CJ_APA_105
nct id: NCT03043521
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare and evaluate impact on pharmacodynamic
      characteristics of CJ-12420 and dexlansoprazole with evening dosing in healthy male
      volunteers
Evaluation Criteria:

        1. Pharmacokinetic Endpoints Cmax, tmax, AUClast of CJ-12420

        2. Pharmacodynamics Endpoints Time pH > 4 Time pH > 6 Integrated acidity Percent inhibition
           of integrated acidity Percent inhibition time gastric pH ≤ 4 Median pH

        3. Safety Assessments Physical examination, ECGs, vital signs (blood pressure, heart rate,
           body temperature), laboratory test (CBC, Chemistry, UA), and adverse events (AEs)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time pH > 4 of CJ-12420
time frame: 24 hours pH
description: intragastric pH
measure: Cmax of CJ-12420
time frame: up to 20 hours
description: maximum measured plasma concentraion
measure: AUClast of CJ-12420
time frame: up to 20 hours
description: The area under the plasma concentration versus time curve from time 0 to the last measurable concentration
measure: Cmax of dexlansoprazole
time frame: up to 20 hours
description: maximum measured plasma concentraion
measure: AUClast of dexlansoprazole
time frame: up to 20 hours
description: The area under the plasma concentration versus time curve from time 0 to the last measurable concentration
measure: Time pH > 4 of dexlansoprazole
time frame: 24 hours pH
description: intragastric pH
measure: Median pH > 4 of CJ-12420
time frame: 24 hours pH
description: intragastric pH
measure: Median pH > 4 of dexlansoprazole
time frame: 24 hours pH
description: intragastric pH
arm group label: CJ-12420 50mg
arm group type: Experimental
description: T1=CJ-12420 50mg QD evening (9PM)
arm group label: CJ-12420 100mg
arm group type: Experimental
description: T2=CJ-12420 100mg QD evening (9PM)
arm group label: CJ-12420 200mg
arm group type: Experimental
description: T3=CJ-12420 200mg QD evening (9PM)
arm group label: Dexlansopazole 60mg
arm group type: Active Comparator
description: R=dexlansoprazole 60mg QD evening (9p.m)
intervention type: Drug
intervention name: Dexlansoprazole 60 MG
arm group label: Dexlansopazole 60mg
other name: R
intervention type: Drug
intervention name: CJ-12420 50mg
arm group label: CJ-12420 50mg
other name: T1
intervention type: Drug
intervention name: CJ-12420 100mg
arm group label: CJ-12420 100mg
other name: T2
intervention type: Drug
intervention name: CJ-12420 200mg
arm group label: CJ-12420 200mg
other name: T3
criteria: 
gender: Male
gender based: Yes
gender description: Healthy male volunteers
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eunji Kim
role: Study Director
affiliation: CJ HealthCare Corp.
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Dexlansoprazole
mesh term: Lansoprazole
sharing ipd: No