<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/NCT03011996</url>
  </required_header>
  <id_info>
    <org_study_id>CJ_APA_107</org_study_id>
    <nct_id>NCT03011996</nct_id>
  </id_info>
  <brief_title>To Investigate PK and PD of CJ-12420, Clarithromycin, Amoxicillin After Multiple Dose Administration</brief_title>
  <official_title>An Open-label, Randomized Study to Evaluate Pharmacokinetic Interaction, Pharmacodynamics and Safety After Multiple Oral Dosing of CJ-12420 and Amoxicillin/Clarithromycin in Healthy Subjects</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cohort 1&#xD;
&#xD;
      To evaluate the pharmacokinetic interactions of CJ-12420 after multiple oral doses of&#xD;
      CJ-12420 given alone or in combination with amoxicillin/clarithromycin in healthy subjects.&#xD;
&#xD;
      Cohort 2&#xD;
&#xD;
      To evaluate the pharmacodynamic profiles of CJ-12420 after multiple oral doses of CJ-12420 in&#xD;
      combination with amoxicillin/clarithromycin in healthy subjects as compared to an active&#xD;
      control group, i.e., pantoprazole in combination with amoxicillin/clarithromycin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate the pharmacokinetic the drug-drug interaction of CJ-12420 and&#xD;
      amoxicillin/clarithromycin and investigate the pharmacodynamic of co-administration of&#xD;
      CJ-12420 and amoxicillin and clarithromycin.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2016</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">February 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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peak Plasma Concentration (Cmax) of CJ-12420, clarithromycin and amoxicillin</measure>
    <time_frame>Up to 120 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC) of CJ-12420, clarithromycin and amoxicillin</measure>
    <time_frame>Up to 120 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of maximum observed concentraion(tmax) of CJ-12420, clarithromycin and amoxicillin</measure>
    <time_frame>Up to 120 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Half life(t1/2) of CJ-12420, clarithromycin and amoxicillin</measure>
    <time_frame>Up to 120 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oral clearance at steady state(CLss/F) of CJ-12420, clarithromycin and amoxicillin</measure>
    <time_frame>Up to 120 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution at steady state(Vdss/F) of CJ-12420, clarithromycin and amoxicillin</measure>
    <time_frame>Up to 120 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>median pH</measure>
    <time_frame>Up to 24 hours</time_frame>
    <description>Data from the pH probe monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time at pH &gt; 3 (%)</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; 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>6</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Drug Interaction</condition>
  <condition>Pharmacokinetic</condition>
  <condition>Pharmacodynamic</condition>
  <arm_group>
    <arm_group_label>CJ-12420 100mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CJ-12420 100mg BID for 5 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CJ-12420 50mg + CLR 500mg + AMX 1g</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>coadministration of CJ-12420 50mg and CLR 500mg/AMX 1g BID for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pantoprazole 40mg + CLR 500mg + AMX 1g</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>coadministration of Pantoprazole 40mg and CLR 500mg/AMX 1g BID for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CJ-12420 100mg + CLR 500mg + AMX 1g</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>coadministration of CJ-12420 100mg, CLR 500mg/AMX 1g BID for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CLR 500mg/AMX 1g</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CLR 500mg/AMX 1g BID for 5 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CJ-12420 100mg + CLR 500mg/AMX 1g</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>coadministration of CJ-12420 100mg and CLR 500mg/AMX 1g BID for 7 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CLR 500mg</intervention_name>
    <description>Cohort 1: bid for 5 days Cohort 2: bid for 7 days</description>
    <arm_group_label>CJ-12420 100mg + CLR 500mg + AMX 1g</arm_group_label>
    <arm_group_label>CJ-12420 100mg + CLR 500mg/AMX 1g</arm_group_label>
    <arm_group_label>CJ-12420 50mg + CLR 500mg + AMX 1g</arm_group_label>
    <arm_group_label>CLR 500mg/AMX 1g</arm_group_label>
    <arm_group_label>Pantoprazole 40mg + CLR 500mg + AMX 1g</arm_group_label>
    <other_name>Clarithromycin 500mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CJ-12420 100mg</intervention_name>
    <description>Cohort 1: bid for 5 days Cohort 2: bid for 7 days</description>
    <arm_group_label>CJ-12420 100mg</arm_group_label>
    <arm_group_label>CJ-12420 100mg + CLR 500mg + AMX 1g</arm_group_label>
    <arm_group_label>CJ-12420 100mg + CLR 500mg/AMX 1g</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CJ-12420 50mg</intervention_name>
    <description>Cohort 2: bid for 7 days</description>
    <arm_group_label>CJ-12420 50mg + CLR 500mg + AMX 1g</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AMX 1g</intervention_name>
    <description>Cohort 1: bid for 5 days Cohort 2: bid for 7 days</description>
    <arm_group_label>CJ-12420 100mg + CLR 500mg + AMX 1g</arm_group_label>
    <arm_group_label>CJ-12420 100mg + CLR 500mg/AMX 1g</arm_group_label>
    <arm_group_label>CJ-12420 50mg + CLR 500mg + AMX 1g</arm_group_label>
    <arm_group_label>CLR 500mg/AMX 1g</arm_group_label>
    <arm_group_label>Pantoprazole 40mg + CLR 500mg + AMX 1g</arm_group_label>
    <other_name>Amoxicillin 1g</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pantoprazole 40mg</intervention_name>
    <description>Cohort 2: bid for 7 days</description>
    <arm_group_label>Pantoprazole 40mg + CLR 500mg + AMX 1g</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male volunteers aged ≥19 and ≤45 years at screening;&#xD;
&#xD;
          2. No congenital or chronic disease, and no morbid symptoms or findings on screening&#xD;
             tests;&#xD;
&#xD;
          3. Body mass index (BMI) ≥18.5 and ≤28 kg/m2;&#xD;
&#xD;
          4. Considered eligible based on medical examinations (including interview, vital signs,&#xD;
             12-lead ECG, physical exam and laboratory tests) which are set and performed in&#xD;
             accordance with the nature of investigational product by the investigator;&#xD;
&#xD;
          5. Voluntary consent to participate in the study after being fully informed of purpose&#xD;
             and procedures of the study, and profiles of investigational product prior to the&#xD;
             participation;&#xD;
&#xD;
          6. For Cohort 2, positive on 13C urea breath test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Medical history&#xD;
&#xD;
               1. History or current evidence for diseases considered clinically relevant by the&#xD;
                  investigator including hepatic, renal, gastrointestinal, respiratory,&#xD;
                  musculoskeletal, endocrine, neurologic, hemato-oncological, urinary, or&#xD;
                  cardiovascular (including cardiac arrhythmia) diseases;&#xD;
&#xD;
               2. History of gastrointestinal diseases (such as gastritis, gastrodynia,&#xD;
                  gastroesophageal reflux disease, Crohn's disease and ulcer) or abdominal surgery&#xD;
                  (except for simple appendectomy or herniotomy) which are considered to have&#xD;
                  potential effect on drug absorption by the investigator;&#xD;
&#xD;
               3. For Cohort 2, previous treatment failure for H. pylori eradication.&#xD;
&#xD;
          2. Laboratory tests and ECG&#xD;
&#xD;
               1. AST or ALT ≥ 1.25 x upper limit of normal (ULN);&#xD;
&#xD;
               2. Total bilirubin ≥ 1.5 x ULN;&#xD;
&#xD;
               3. eGFR calculated by CKD-EPI formula &lt; 80 mL/min;&#xD;
&#xD;
               4. Any clinically relevant ECG abnormalities.&#xD;
&#xD;
          3. Allergy and drug abuse&#xD;
&#xD;
               1. History of hypersensitivity to drugs containing investigational products&#xD;
                  (penicillins, cephems, macrolides, pantoprazole and benzimidazole) and other&#xD;
                  drugs (including aspirin and antibiotics);&#xD;
&#xD;
               2. History of drug abuse or positive on drug screening test.&#xD;
&#xD;
          4. Drug/dietary restrictions&#xD;
&#xD;
               1. Medications (including herbal supplements) or abnormal diet (e.g., grapefruit&#xD;
                  juice &gt; 1 L/day, excessive garlic, broccoli, kale, etc.) which may have effect on&#xD;
                  absorption, distribution, metabolism and excretion of investigational products&#xD;
                  within 28 days prior to the first study dose;&#xD;
&#xD;
               2. Use of prescription drugs, over-the-counter drugs (OTCs) or vitamins within 10&#xD;
                  days prior to the first study dose;&#xD;
&#xD;
               3. Participating in other study and receive investigational product within 3 months&#xD;
                  prior to the first study dose.&#xD;
&#xD;
          5. Blood donation and transfusion&#xD;
&#xD;
               1. Whole blood donation within 60 days prior to the first study dose;&#xD;
&#xD;
               2. Donation of blood components or transfusion within 30 days prior to the first&#xD;
                  study dose.&#xD;
&#xD;
          6. Pregnancy and contraception&#xD;
&#xD;
               1. Pregnant or breast-feeding;&#xD;
&#xD;
               2. Subject or his partner's inability to use of medically qualifying&#xD;
                  dual-contraceptive methods or medically acceptable contraception (including&#xD;
                  intrauterine device with established pregnancy failure rate, barrier methods with&#xD;
                  spermicide, vasectomy, tubectomy, tubal ligation and hysterectomy) from screening&#xD;
                  to 30 days of the last dose of investigational product.&#xD;
&#xD;
          7. Others&#xD;
&#xD;
               1. Heavy use of alcohol (average alcohol intake ≥30 g/day) or positive on alcohol&#xD;
                  test;&#xD;
&#xD;
               2. Heavy smoker (&gt;10 cigarettes/day);&#xD;
&#xD;
               3. Caffeine intake &gt; 400 mg/day;&#xD;
&#xD;
               4. Any clinically relevant findings considered inappropriate for study participation&#xD;
                  at the discretion of the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jae-Gook Shin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Inje university college of medicine Busan Paik Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inje University Busan Baik Hospital</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>May 11, 2017</last_update_submitted>
  <last_update_submitted_qc>May 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 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>Amoxicillin</mesh_term>
    <mesh_term>Clarithromycin</mesh_term>
    <mesh_term>Pantoprazole</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/NCT03011996
org study id: CJ_APA_107
nct id: NCT03011996
lead sponsor: 
has dmc: No
Cohort 1

      To evaluate the pharmacokinetic interactions of CJ-12420 after multiple oral doses of
      CJ-12420 given alone or in combination with amoxicillin/clarithromycin in healthy subjects.

      Cohort 2

      To evaluate the pharmacodynamic profiles of CJ-12420 after multiple oral doses of CJ-12420 in
      combination with amoxicillin/clarithromycin in healthy subjects as compared to an active
      control group, i.e., pantoprazole in combination with amoxicillin/clarithromycin.
To evaluate the pharmacokinetic the drug-drug interaction of CJ-12420 and
      amoxicillin/clarithromycin and investigate the pharmacodynamic of co-administration of
      CJ-12420 and amoxicillin and clarithromycin.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Peak Plasma Concentration (Cmax) of CJ-12420, clarithromycin and amoxicillin
time frame: Up to 120 hours
measure: Area under the plasma concentration versus time curve (AUC) of CJ-12420, clarithromycin and amoxicillin
time frame: Up to 120 hours
measure: Time of maximum observed concentraion(tmax) of CJ-12420, clarithromycin and amoxicillin
time frame: Up to 120 hours
measure: Half life(t1/2) of CJ-12420, clarithromycin and amoxicillin
time frame: Up to 120 hours
measure: Oral clearance at steady state(CLss/F) of CJ-12420, clarithromycin and amoxicillin
time frame: Up to 120 hours
measure: Apparent volume of distribution at steady state(Vdss/F) of CJ-12420, clarithromycin and amoxicillin
time frame: Up to 120 hours
measure: median pH
time frame: Up to 24 hours
description: Data from the pH probe monitoring
measure: Time at pH > 3 (%)
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 > 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 100mg
arm group type: Experimental
description: CJ-12420 100mg BID for 5 days
arm group label: CJ-12420 50mg + CLR 500mg + AMX 1g
arm group type: Experimental
description: coadministration of CJ-12420 50mg and CLR 500mg/AMX 1g BID for 7 days
arm group label: Pantoprazole 40mg + CLR 500mg + AMX 1g
arm group type: Active Comparator
description: coadministration of Pantoprazole 40mg and CLR 500mg/AMX 1g BID for 7 days
arm group label: CJ-12420 100mg + CLR 500mg + AMX 1g
arm group type: Experimental
description: coadministration of CJ-12420 100mg, CLR 500mg/AMX 1g BID for 7 days
arm group label: CLR 500mg/AMX 1g
arm group type: Experimental
description: CLR 500mg/AMX 1g BID for 5 days
arm group label: CJ-12420 100mg + CLR 500mg/AMX 1g
arm group type: Experimental
description: coadministration of CJ-12420 100mg and CLR 500mg/AMX 1g BID for 7 days
intervention type: Drug
intervention name: CLR 500mg
description: Cohort 1: bid for 5 days Cohort 2: bid for 7 days
arm group label: CJ-12420 100mg + CLR 500mg + AMX 1g
arm group label: CJ-12420 100mg + CLR 500mg/AMX 1g
arm group label: CJ-12420 50mg + CLR 500mg + AMX 1g
arm group label: CLR 500mg/AMX 1g
arm group label: Pantoprazole 40mg + CLR 500mg + AMX 1g
other name: Clarithromycin 500mg
intervention type: Drug
intervention name: CJ-12420 100mg
description: Cohort 1: bid for 5 days Cohort 2: bid for 7 days
arm group label: CJ-12420 100mg
arm group label: CJ-12420 100mg + CLR 500mg + AMX 1g
arm group label: CJ-12420 100mg + CLR 500mg/AMX 1g
intervention type: Drug
intervention name: CJ-12420 50mg
description: Cohort 2: bid for 7 days
arm group label: CJ-12420 50mg + CLR 500mg + AMX 1g
intervention type: Drug
intervention name: AMX 1g
description: Cohort 1: bid for 5 days Cohort 2: bid for 7 days
arm group label: CJ-12420 100mg + CLR 500mg + AMX 1g
arm group label: CJ-12420 100mg + CLR 500mg/AMX 1g
arm group label: CJ-12420 50mg + CLR 500mg + AMX 1g
arm group label: CLR 500mg/AMX 1g
arm group label: Pantoprazole 40mg + CLR 500mg + AMX 1g
other name: Amoxicillin 1g
intervention type: Drug
intervention name: Pantoprazole 40mg
description: Cohort 2: bid for 7 days
arm group label: Pantoprazole 40mg + CLR 500mg + AMX 1g
criteria: 
gender: All
minimum age: 19 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jae-Gook Shin
role: Principal Investigator
affiliation: Inje university college of medicine Busan Paik Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Amoxicillin
mesh term: Clarithromycin
mesh term: Pantoprazole
sharing ipd: Undecided