<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/NCT04485884</url>
  </required_header>
  <id_info>
    <org_study_id>IN_BTK_101</org_study_id>
    <nct_id>NCT04485884</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of IN-C005 in Healthy Male Subjects</brief_title>
  <official_title>An Open-label, Randomized, Single and Multiple Dosing Phase I Clinical Trial to Evaluate Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of IN-C005 After Oral Administration in Healthy Korean and Caucasian Male 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>Yes</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 main purpose of this study is to evaluate pharmacokinetics/pharmacodynamics and&#xD;
      safety/tolerability of IN-C005 after oral administration in healthy Korean and Caucasian male&#xD;
      subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      [Pharmacokinetic Assessments]: Plasma concentrations of IN-C005 and its metabolite will be&#xD;
      measured&#xD;
&#xD;
        1. Single Dosing Group (Korean Subjects)&#xD;
&#xD;
             -  Primary endpoints: Cmax and AUClast of IN-C005&#xD;
&#xD;
             -  Secondary endpoints: AUClast, Cmax, AUCinf, Tmax, t½, CL/F, and Vd/F of M1; AUCinf,&#xD;
                Tmax, t½, CL/F, and Vd/F of IN-C005&#xD;
&#xD;
        2. Multiple Dosing Group (Caucasian Subjects)&#xD;
&#xD;
             -  Primary endpoints: Cmax, AUClast, Cmax,ss, and AUCτ,ss of IN-C005&#xD;
&#xD;
             -  Secondary endpoints: For M1, AUClast, Cmax, Cmax,ss, AUCinf, AUCτ,ss, Tmax,&#xD;
                Tmax,ss, t½, CL/F, and Vd/F; for IN-C005, AUCinf, Tmax, Tmax,ss, Cmin,ss, t½, CL/F,&#xD;
                Vd/F, Cav,ss, CLss/F, Vss/F, PTF (peak to trough fluctuation), and R (accumulation&#xD;
                ratio)&#xD;
&#xD;
      [Pharmacodynamic Assessments]:&#xD;
&#xD;
        1. Single Dosing Group (Korean Subjects)&#xD;
&#xD;
             -  Intragastric pH&#xD;
&#xD;
                  -  Percent (%) duration of pH ≥4 in 24 hrs&#xD;
&#xD;
                  -  Mean pH&#xD;
&#xD;
                  -  Median pH&#xD;
&#xD;
                  -  Change in pH from baseline to post-dose (Δduration %, Δmean pH, Δmedian pH,&#xD;
                     etc.)&#xD;
&#xD;
             -  Serum gastrin level&#xD;
&#xD;
                  -  AUEGlast&#xD;
&#xD;
                  -  Gmax&#xD;
&#xD;
                  -  Change in gastrin level from baseline to study treatment (1d, 8d, and&#xD;
                     15d)(ΔAUEGlast, ΔGmax, etc.)&#xD;
&#xD;
        2. Multiple Dosing Group (Caucasian Subjects)&#xD;
&#xD;
             -  Intragastric pH&#xD;
&#xD;
                  -  Percent (%) duration of pH ≥4 in 24 hrs&#xD;
&#xD;
                  -  Mean pH&#xD;
&#xD;
                  -  Median pH&#xD;
&#xD;
                  -  Change in pH from baseline to post-single dose and post-multiple doses&#xD;
                     (Δduration %, Δmean pH, Δmedian pH, etc.)&#xD;
&#xD;
             -  Serum gastrin level&#xD;
&#xD;
                  -  AUEGlast&#xD;
&#xD;
                  -  Gmax&#xD;
&#xD;
                  -  Change in gastrin level from baseline to 1d and 7d (ΔAUEGlast, ΔGmax, etc.)&#xD;
&#xD;
      [Safety Assessments] &lt;Single Dosing Group (Korean Subjects) and Multiple Dosing Group&#xD;
      (Caucasian Subjects)&gt;&#xD;
&#xD;
        1. AEs will be monitored with observable/objective symptoms, etc.&#xD;
&#xD;
        2. Physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory&#xD;
           tests&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 13, 2020</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">March 2021</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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects), Multiple Dosing Group (Caucasian Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Cmax of IN-C005</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects), Multiple Dosing Group (Caucasian Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>AUClast of IN-C005</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Cmax,ss of IN-C005</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>AUCtau,ss of IN-C005</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>AUClast of M1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Cmax of M1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>AUCinf of IN-C005 and M1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Tmax of IN-C005 and M1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>t½ of IN-C005 and M1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>CL/F of IN-C005 and M1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Vd/F of IN-C005 and M1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>AUClast of M1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Cmax of M1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Cmax,ss of M1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>AUCinf of IN-C005 and M1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>AUCtau,ss of M1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Tmax of IN-C005 and M1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Tmax,ss of IN-C005 and M1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>t½ of IN-C005 and M1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>CL/F of IN-C005 and M1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Vd/F of IN-C005 and M1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Cmin,ss of IN-C005</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Cav,ss of IN-C005</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>CLss/F of IN-C005</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Vss/F of IN-C005</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>PTF (peak to trough fluctuation) of IN-C005</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>R (accumulation ratio) of IN-C005</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]</measure>
    <time_frame>Pre-dose(0h) up to 24 hours after IP administration in each period</time_frame>
    <description>Percent (%) duration of pH ≥ 4 in 24 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]</measure>
    <time_frame>Pre-dose(0h) up to 24 hours after IP administration in each period</time_frame>
    <description>Mean pH</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]</measure>
    <time_frame>Pre-dose(0h) up to 24 hours after IP administration in each period</time_frame>
    <description>Median pH</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]</measure>
    <time_frame>Pre-dose(0h) up to 24 hours after IP administration in each period</time_frame>
    <description>Change in pH from baseline to post-dose of Δduration %</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]</measure>
    <time_frame>Pre-dose(0h) up to 24 hours after IP administration in each period</time_frame>
    <description>Change in pH from baseline to post-dose of Δmean pH</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]</measure>
    <time_frame>Pre-dose(0h) up to 24 hours after IP administration in each period</time_frame>
    <description>Change in pH from baseline to post-dose of Δmedian pH</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>AUEGlast(Area under the concentration-time curve of serum gastrin from time zero to the last point of quantifiable concentration)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Gmax (Maximum plasma concentration of gastrin)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Change in gastrin level from baseline to 1d and 7d of ΔAUEGlast</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Change in gastrin level from baseline to 1d and 7d of ΔGmax</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects)]</measure>
    <time_frame>Pre-dose(0h) up to 24 hours after IP administration in each period</time_frame>
    <description>Percent (%) duration of pH ≥ 4 in 24 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects)]</measure>
    <time_frame>Pre-dose(0h) up to 24 hours after IP administration in each period</time_frame>
    <description>Mean pH</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects)]</measure>
    <time_frame>Pre-dose(0h) up to 24 hours after IP administration in each period</time_frame>
    <description>Median pH</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects)]</measure>
    <time_frame>Pre-dose(0h) up to 24 hours after IP administration in each period</time_frame>
    <description>Change in pH from baseline to post-single dose and post-multiple dose (Δduration %, Δmean pH, Δmedian pH, etc)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects)]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>AUEGlast(Area under the concentration-time curve of serum gastrin from time zero to the last point of quantifiable concentration)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Gmax (Maximum plasma concentration of gastrin)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Change in gastrin level from baseline to 1d and 7d of ΔAUEGlast</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects]</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Change in gastrin level from baseline to 1d and 7d of ΔGmax</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IN-C005 dose A</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IN-C005 dose B</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IN-C005 dose C</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IN-C005 dose D</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IN-C005 dose E</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group F</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IN-C005 dose F</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IN-C005 dose A</intervention_name>
    <description>One time dose of IN-C005 dose A taken orally.</description>
    <arm_group_label>Group A</arm_group_label>
    <other_name>IN-C005</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IN-C005 dose B</intervention_name>
    <description>One time dose of IN-C005 dose B taken orally.</description>
    <arm_group_label>Group B</arm_group_label>
    <other_name>IN-C005</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IN-C005 dose C</intervention_name>
    <description>One time dose of IN-C005 dose C taken orally.</description>
    <arm_group_label>Group C</arm_group_label>
    <other_name>IN-C005</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IN-C005 dose D</intervention_name>
    <description>Oral administration of IN-C005 dose D once daily for 7 days.</description>
    <arm_group_label>Group D</arm_group_label>
    <other_name>IN-C005</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IN-C005 dose E</intervention_name>
    <description>Oral administration of IN-C005 dose E once daily for 7 days.</description>
    <arm_group_label>Group E</arm_group_label>
    <other_name>IN-C005</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IN-C005 dose F</intervention_name>
    <description>Oral administration of IN-C005 dose F once daily for 7 days.</description>
    <arm_group_label>Group F</arm_group_label>
    <other_name>IN-C005</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  [For single dosing group only] Healthy Korean male aged 19 to 50 years (inclusive) at&#xD;
             the time of signing the informed consent form (ICF)&#xD;
&#xD;
          -  [For multiple dosing group only] Healthy Caucasian male aged 19 to 50 years&#xD;
             (inclusive) at the time of signing the ICF (Caucasian subject is defined as a European&#xD;
             who was born in Europe, has the duration of residence outside of Europe less than 10&#xD;
             years, and both of whose parents and grandparents are European-born).&#xD;
&#xD;
          -  Body mass index (BMI) of ≥ 18.0 and ≤ 28.0 kg/m2 with a body weight ≥ 55.0 kg at&#xD;
             screening. (BMI (kg/m2) = weight (kg) / {height (m)}2)&#xD;
&#xD;
          -  Subjects with negative result in serum Helicobacter pylori antibody test.&#xD;
&#xD;
          -  Voluntary participation in the study after being fully informed of and understanding&#xD;
             the study completely, and provides his written informed consent prior to screening&#xD;
             procedure&#xD;
&#xD;
          -  Subjects who are eligible for this study in the opinion of the investigator based on&#xD;
             the results of physical examination, clinical laboratory tests, interview, etc.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or current evidence of clinically significant disorder of hepatic, renal,&#xD;
             nervous, respiratory, endocrine, hemato-oncologic, cardiovascular, urinary, and/or&#xD;
             psychiatric system.&#xD;
&#xD;
          -  History or current evidence of gastrointestinal disease that may affect the safety and&#xD;
             PD assessment for study treatment (e.g., gastrointestinal ulcer, gastritis, gastric&#xD;
             cramp, gastroesophageal reflux disease, and Crohn's disease) or a history of&#xD;
             gastrointestinal surgery (except for simple appendectomy or herniotomy).&#xD;
&#xD;
          -  History or current evidence of clinically significant hypersensitivity to drugs&#xD;
             containing IN-C005 or any ingredient of proton pump inhibitors and other drugs (such&#xD;
             as aspirin and antibiotics).&#xD;
&#xD;
          -  Subjects with positive result on serology tests (for hepatitis B, human&#xD;
             immunodeficiency virus [HIV], and hepatitis C).&#xD;
&#xD;
          -  Subjects with blood level of total bilirubin, AST (GOT), or ALT (GPT) &gt; 1.5 X upper&#xD;
             limit of normal range(ULN) at procedures performed during the screening period&#xD;
             including those performed additionally.&#xD;
&#xD;
          -  Subjects with eGFR &lt; 60 ml/min/1.73m2 during the screening period including those&#xD;
             performed additionally.&#xD;
&#xD;
          -  Systolic blood pressure (SBP) of &lt; 90 mmHg or &gt; 140 mmHg, diastolic blood pressure&#xD;
             (DBP) of &lt; 50 mmHg or &gt; 95 mmHg, or pulse rate of &lt; 45 beats/min or &gt; 100 beats/min on&#xD;
             vital signs as measured in sitting position after taking a rest for at least 5 minutes&#xD;
             at screening.&#xD;
&#xD;
          -  Subjects with anatomical disorder that precludes insertion and maintenance of&#xD;
             intragastric pH meter catheter or is expected to be intolerable to insertion of&#xD;
             intragastric pH meter catheter.&#xD;
&#xD;
          -  History of drug abuse or positive response to drug abuse on urine drug screening test.&#xD;
&#xD;
          -  Subjects who received any prescription drug or herbal medication within 2 weeks of or&#xD;
             any over-the-counter (OTC) drug, dietary supplements, or vitamins within 1 week of&#xD;
             scheduled first dose or subjects who are expected to receive such medication during&#xD;
             the study. (Note: a subject may participate in the study at the discretion of the&#xD;
             investigator, provided that the subject meets all the other criteria).&#xD;
&#xD;
          -  Subjects who participated in any other clinical study or bioequivalence study and&#xD;
             received investigational product within 6 months prior to the scheduled first dose.&#xD;
&#xD;
          -  Subjects who have donated whole blood within 2 months prior to the scheduled first&#xD;
             dose, or have donated blood components or received transfusion within a month prior to&#xD;
             the scheduled first dose.&#xD;
&#xD;
          -  Excessive caffeine intake (&gt; 5 units/day), continued use of alcohol (&gt; 21 units/week,&#xD;
             1 unit = 10 g of pure alcohol), or inability to stop drinking while hospitalized.&#xD;
&#xD;
          -  Positive result for cotinine on urine drug screening test or inability to quit smoking&#xD;
             throughout the study.&#xD;
&#xD;
          -  Subjects who have taken grapefruit-containing foods during the period from 24 hours&#xD;
             (hrs) before hospitalization to discharge, or are unable to avoid&#xD;
             grapefruit-containing foods during this period.&#xD;
&#xD;
          -  Subjects who are unable to avoid caffeine-containing foods (e.g., coffee, tea [red&#xD;
             tea, green tee, etc.], soda, coffee milk, and nutritive tonic drink) during the period&#xD;
             from 24 hrs before hospitalization to discharge.&#xD;
&#xD;
          -  Subjects who are unable to use medically acceptable contraceptive methods throughout&#xD;
             the study.&#xD;
&#xD;
             ► Medically acceptable contraceptive methods include:&#xD;
&#xD;
             ① Use of intrauterine device with a proven birth control failure rate by the spouse&#xD;
             (or partner);&#xD;
&#xD;
             ② Simultaneous use of (male or female) barrier method and spermicide; and&#xD;
&#xD;
             ③ Surgical sterilization of the subject or his partner (e.g., vasectomy,&#xD;
             salpingectomy, tubal ligation, or hysterectomy).&#xD;
&#xD;
          -  Subjects who are determined ineligible for study participation by the investigator for&#xD;
             other reasons such as clinical laboratory abnormalities.&#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, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital, Clinical Trial Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Youngshin Keum, R.Ph, Pharm.D</last_name>
    <phone>+82-2-6477-0204</phone>
    <email>ys.keum@inno-n.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Seokuee Kim, MD, PhD</last_name>
    <phone>+82-2-6477-0207</phone>
    <email>seokuee.kim@inno-n.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>November 5, 2020</last_update_submitted>
  <last_update_submitted_qc>November 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04485884
org study id: IN_BTK_101
nct id: NCT04485884
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The main purpose of this study is to evaluate pharmacokinetics/pharmacodynamics and
      safety/tolerability of IN-C005 after oral administration in healthy Korean and Caucasian male
      subjects.
[Pharmacokinetic Assessments]: Plasma concentrations of IN-C005 and its metabolite will be
      measured

        1. Single Dosing Group (Korean Subjects)

             -  Primary endpoints: Cmax and AUClast of IN-C005

             -  Secondary endpoints: AUClast, Cmax, AUCinf, Tmax, t½, CL/F, and Vd/F of M1; AUCinf,
                Tmax, t½, CL/F, and Vd/F of IN-C005

        2. Multiple Dosing Group (Caucasian Subjects)

             -  Primary endpoints: Cmax, AUClast, Cmax,ss, and AUCτ,ss of IN-C005

             -  Secondary endpoints: For M1, AUClast, Cmax, Cmax,ss, AUCinf, AUCτ,ss, Tmax,
                Tmax,ss, t½, CL/F, and Vd/F; for IN-C005, AUCinf, Tmax, Tmax,ss, Cmin,ss, t½, CL/F,
                Vd/F, Cav,ss, CLss/F, Vss/F, PTF (peak to trough fluctuation), and R (accumulation
                ratio)

      [Pharmacodynamic Assessments]:

        1. Single Dosing Group (Korean Subjects)

             -  Intragastric pH

                  -  Percent (%) duration of pH ≥4 in 24 hrs

                  -  Mean pH

                  -  Median pH

                  -  Change in pH from baseline to post-dose (Δduration %, Δmean pH, Δmedian pH,
                     etc.)

             -  Serum gastrin level

                  -  AUEGlast

                  -  Gmax

                  -  Change in gastrin level from baseline to study treatment (1d, 8d, and
                     15d)(ΔAUEGlast, ΔGmax, etc.)

        2. Multiple Dosing Group (Caucasian Subjects)

             -  Intragastric pH

                  -  Percent (%) duration of pH ≥4 in 24 hrs

                  -  Mean pH

                  -  Median pH

                  -  Change in pH from baseline to post-single dose and post-multiple doses
                     (Δduration %, Δmean pH, Δmedian pH, etc.)

             -  Serum gastrin level

                  -  AUEGlast

                  -  Gmax

                  -  Change in gastrin level from baseline to 1d and 7d (ΔAUEGlast, ΔGmax, etc.)

      [Safety Assessments] <Single Dosing Group (Korean Subjects) and Multiple Dosing Group
      (Caucasian Subjects)>

        1. AEs will be monitored with observable/objective symptoms, etc.

        2. Physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory
           tests
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects), Multiple Dosing Group (Caucasian Subjects)]
time frame: Up to 48 hours
description: Cmax of IN-C005
measure: Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects), Multiple Dosing Group (Caucasian Subjects)]
time frame: Up to 48 hours
description: AUClast of IN-C005
measure: Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
time frame: Up to 48 hours
description: Cmax,ss of IN-C005
measure: Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
time frame: Up to 48 hours
description: AUCtau,ss of IN-C005
measure: Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]
time frame: Up to 48 hours
description: AUClast of M1
measure: Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]
time frame: Up to 48 hours
description: Cmax of M1
measure: Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]
time frame: Up to 48 hours
description: AUCinf of IN-C005 and M1
measure: Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]
time frame: Up to 48 hours
description: Tmax of IN-C005 and M1
measure: Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]
time frame: Up to 48 hours
description: t½ of IN-C005 and M1
measure: Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]
time frame: Up to 48 hours
description: CL/F of IN-C005 and M1
measure: Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]
time frame: Up to 48 hours
description: Vd/F of IN-C005 and M1
measure: Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
time frame: Up to 48 hours
description: AUClast of M1
measure: Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
time frame: Up to 48 hours
description: Cmax of M1
measure: Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
time frame: Up to 48 hours
description: Cmax,ss of M1
measure: Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
time frame: Up to 48 hours
description: AUCinf of IN-C005 and M1
measure: Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
time frame: Up to 48 hours
description: AUCtau,ss of M1
measure: Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
time frame: Up to 48 hours
description: Tmax of IN-C005 and M1
measure: Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
time frame: Up to 48 hours
description: Tmax,ss of IN-C005 and M1
measure: Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
time frame: Up to 48 hours
description: t½ of IN-C005 and M1
measure: Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
time frame: Up to 48 hours
description: CL/F of IN-C005 and M1
measure: Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
time frame: Up to 48 hours
description: Vd/F of IN-C005 and M1
measure: Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
time frame: Up to 48 hours
description: Cmin,ss of IN-C005
measure: Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
time frame: Up to 48 hours
description: Cav,ss of IN-C005
measure: Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
time frame: Up to 48 hours
description: CLss/F of IN-C005
measure: Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
time frame: Up to 48 hours
description: Vss/F of IN-C005
measure: Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
time frame: Up to 48 hours
description: PTF (peak to trough fluctuation) of IN-C005
measure: Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
time frame: Up to 48 hours
description: R (accumulation ratio) of IN-C005
measure: Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
time frame: Pre-dose(0h) up to 24 hours after IP administration in each period
description: Percent (%) duration of pH ≥ 4 in 24 hours
measure: Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
time frame: Pre-dose(0h) up to 24 hours after IP administration in each period
description: Mean pH
measure: Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
time frame: Pre-dose(0h) up to 24 hours after IP administration in each period
description: Median pH
measure: Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
time frame: Pre-dose(0h) up to 24 hours after IP administration in each period
description: Change in pH from baseline to post-dose of Δduration %
measure: Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
time frame: Pre-dose(0h) up to 24 hours after IP administration in each period
description: Change in pH from baseline to post-dose of Δmean pH
measure: Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
time frame: Pre-dose(0h) up to 24 hours after IP administration in each period
description: Change in pH from baseline to post-dose of Δmedian pH
measure: Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
time frame: Up to 48 hours
description: AUEGlast(Area under the concentration-time curve of serum gastrin from time zero to the last point of quantifiable concentration)
measure: Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
time frame: Up to 48 hours
description: Gmax (Maximum plasma concentration of gastrin)
measure: Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
time frame: Up to 48 hours
description: Change in gastrin level from baseline to 1d and 7d of ΔAUEGlast
measure: Pharmacodynamic Evaluation [Single Dosing Group (Korean Subjects)]
time frame: Up to 48 hours
description: Change in gastrin level from baseline to 1d and 7d of ΔGmax
measure: Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
time frame: Pre-dose(0h) up to 24 hours after IP administration in each period
description: Percent (%) duration of pH ≥ 4 in 24 hours
measure: Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
time frame: Pre-dose(0h) up to 24 hours after IP administration in each period
description: Mean pH
measure: Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
time frame: Pre-dose(0h) up to 24 hours after IP administration in each period
description: Median pH
measure: Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
time frame: Pre-dose(0h) up to 24 hours after IP administration in each period
description: Change in pH from baseline to post-single dose and post-multiple dose (Δduration %, Δmean pH, Δmedian pH, etc)
measure: Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects)]
time frame: Up to 48 hours
description: AUEGlast(Area under the concentration-time curve of serum gastrin from time zero to the last point of quantifiable concentration)
measure: Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects]
time frame: Up to 48 hours
description: Gmax (Maximum plasma concentration of gastrin)
measure: Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects]
time frame: Up to 48 hours
description: Change in gastrin level from baseline to 1d and 7d of ΔAUEGlast
measure: Pharmacodynamic Evaluation [Multiple Dosing Group (Caucasian Subjects]
time frame: Up to 48 hours
description: Change in gastrin level from baseline to 1d and 7d of ΔGmax
arm group label: Group A
arm group type: Experimental
description: IN-C005 dose A
arm group label: Group B
arm group type: Experimental
description: IN-C005 dose B
arm group label: Group C
arm group type: Experimental
description: IN-C005 dose C
arm group label: Group D
arm group type: Experimental
description: IN-C005 dose D
arm group label: Group E
arm group type: Experimental
description: IN-C005 dose E
arm group label: Group F
arm group type: Experimental
description: IN-C005 dose F
intervention type: Drug
intervention name: IN-C005 dose A
description: One time dose of IN-C005 dose A taken orally.
arm group label: Group A
other name: IN-C005
intervention type: Drug
intervention name: IN-C005 dose B
description: One time dose of IN-C005 dose B taken orally.
arm group label: Group B
other name: IN-C005
intervention type: Drug
intervention name: IN-C005 dose C
description: One time dose of IN-C005 dose C taken orally.
arm group label: Group C
other name: IN-C005
intervention type: Drug
intervention name: IN-C005 dose D
description: Oral administration of IN-C005 dose D once daily for 7 days.
arm group label: Group D
other name: IN-C005
intervention type: Drug
intervention name: IN-C005 dose E
description: Oral administration of IN-C005 dose E once daily for 7 days.
arm group label: Group E
other name: IN-C005
intervention type: Drug
intervention name: IN-C005 dose F
description: Oral administration of IN-C005 dose F once daily for 7 days.
arm group label: Group F
other name: IN-C005
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: In-Jin Jang, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital, Clinical Trial Center
last name: Youngshin Keum, R.Ph, Pharm.D
phone: +82-2-6477-0204
email: ys.keum@inno-n.com
last name: Seokuee Kim, MD, PhD
phone: +82-2-6477-0207
email: seokuee.kim@inno-n.com
facility: 
status: Recruiting
country: Korea, Republic of
responsible party type: Sponsor