<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/NCT04494269</url>
  </required_header>
  <id_info>
    <org_study_id>IN_APA_116</org_study_id>
    <nct_id>NCT04494269</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls</brief_title>
  <official_title>An Open-label, Multi-center, Single-dose, Parallel-group Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls</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>
    <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 compare the pharmacokinetic and safety of tegoprazan&#xD;
      following single oral dose in subjects with hepatic impairment versus healthy control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      [Pharmacokinetic Assessment]&#xD;
&#xD;
        -  Measurements&#xD;
&#xD;
           - Tegoprazan and desmethyl tegoprazan (M1) in blood and urine&#xD;
&#xD;
        -  Endpoints&#xD;
&#xD;
             -  Primary endpoints: AUClast and Cmax of tegoprazan and M1&#xD;
&#xD;
             -  Secondary endpoints: CL/F, t1/2, AUCinf, and fu of tegoprazan; CLrenal and Ae of&#xD;
                tegoprazan and M1&#xD;
&#xD;
      [Safety Assessment]&#xD;
&#xD;
        -  Adverse events (AEs)&#xD;
&#xD;
        -  Clinical laboratory tests&#xD;
&#xD;
        -  Vital sign&#xD;
&#xD;
        -  Physical examination&#xD;
&#xD;
        -  Electrocardiogram (ECG)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 8, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetic Assessment</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>AUClast of tegoprazan and M1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic Assessment</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Cmax of tegoprazan and M1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Assessment</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>CL/F of tegoprazan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Assessment</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>t½ of tegoprazan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Assessment</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>AUCinf of tegoprazan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Assessment</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>fu of tegoprazan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Assessment</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>CLrenal of tegoprazan and M1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Assessment</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Ae of tegoprazan and M1</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">28</enrollment>
  <condition>Hepatic Impairment</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Subjects with normal hepatic function</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single dose of Tegoprazan 50mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects with mild hepatic impairment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of Tegoprazan 50mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects with moderate hepatic impairment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of Tegoprazan 50mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects with severe hepatic impairment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of Tegoprazan 50mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tegoprazan 50mg</intervention_name>
    <description>Oral administration once daily</description>
    <arm_group_label>Subjects with mild hepatic impairment</arm_group_label>
    <arm_group_label>Subjects with moderate hepatic impairment</arm_group_label>
    <arm_group_label>Subjects with normal hepatic function</arm_group_label>
    <arm_group_label>Subjects with severe hepatic impairment</arm_group_label>
    <other_name>K-CAB</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        [Healthy Control Group]&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects aged 19 to 70(inclusive) years at the time of signing the informed consent&#xD;
             form.&#xD;
&#xD;
          -  Subjects with a body weight of ≥ 50 kg and ≤ 90 kg at screening.&#xD;
&#xD;
          -  Subjects with AST, ALT, and ALP levels of ≤ 1.5 × upper limit of the normal reference&#xD;
             range (ULN) with total bilirubin &lt; 2 mg/dL and PT (INR) &lt; 1.7 at screening.&#xD;
&#xD;
          -  Subjects who have no chronic disease or any congenital disease within the last 5 years&#xD;
             and no pathological symptoms or findings as a result of an internal examination&#xD;
&#xD;
          -  Subjects who provide voluntary written informed consent to study participation after&#xD;
             being informed of detailed explanation and fully understanding study objectives,&#xD;
             procedures and characteristics of the investigational product(IP).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who show symptoms of acute disease at the time of screening.&#xD;
&#xD;
          -  Subjects with any clinically significant disease related to ongoing cardiovascular&#xD;
             problem, respiratory system, kidney, endocrine system, hematologic, central nervous&#xD;
             system, mental health disorder, or malignant tumor.&#xD;
&#xD;
          -  Subjects with history or current evidence of gastrointestinal or hepatobiliary disease&#xD;
             which may affect PK evaluation of the IP.&#xD;
&#xD;
          -  Subjects with history or current evidence of clinically significant hypersensitivity&#xD;
             to drugs containing any ingredient of proton pump inhibitors or potassium-competitive&#xD;
             acid blockers and other drugs (such as aspirin and antibiotics).&#xD;
&#xD;
          -  Subjects with systolic blood pressure (BP) of &lt; 90 mmHg or &gt; 160 mmHg, or diastolic BP&#xD;
             of &lt; 50 mmHg or &gt; 100 mmHg at screening.&#xD;
&#xD;
          -  Subjects who have received medication or food which may significantly affect&#xD;
             absorption, distribution, metabolism, or elimination of study drug within 7 days prior&#xD;
             to scheduled study treatment.&#xD;
&#xD;
          -  Subjects who have participated in any other clinical study or bioequivalence study and&#xD;
             received investigational agent within 180 days prior to scheduled study treatment.&#xD;
&#xD;
          -  Subjects who have donated whole blood within 60 days prior to the scheduled study&#xD;
             treatment, or has donated blood components or received transfusion within 30 days&#xD;
             prior to scheduled study treatment.&#xD;
&#xD;
          -  Subjects who are unable to use a medically acceptable contraceptive method throughout&#xD;
             the study.&#xD;
&#xD;
          -  Subjects who are determined ineligible for study participation by the investigator for&#xD;
             other reasons.&#xD;
&#xD;
        [Subjects with Hepatic Impairment]&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with chronic liver disease who meet any of the followings:&#xD;
&#xD;
               -  Chronic Hepatitis B;&#xD;
&#xD;
               -  Chronic Hepatitis C;&#xD;
&#xD;
               -  Alcoholic liver disease;&#xD;
&#xD;
               -  Non-alcoholic fatty liver disease; or&#xD;
&#xD;
               -  Liver fibrosis and cirrhosis.&#xD;
&#xD;
          -  Subjects aged 19 to 70 years (inclusive) at the time of signing the informed consent&#xD;
             form.&#xD;
&#xD;
          -  Subjects with body weight of ≥ 50 kg and ≤ 90 kg with a BMI of ≥ 18.0 kg/m2 and ≤ 30&#xD;
             kg/m2 at screening.&#xD;
&#xD;
          -  Subjects who meet any of following criteria:&#xD;
&#xD;
               -  AST, ALT, or ALP level &gt; 1.5 × ULN at screening;&#xD;
&#xD;
               -  Total bilirubin ≥ 2 mg/dL at screening; or&#xD;
&#xD;
               -  PT (INR) ≥ 1.7 at screening.&#xD;
&#xD;
          -  Subjects who provide voluntary written informed consent to study participation after&#xD;
             being informed of detailed explanation and fully understanding study objectives,&#xD;
             procedures and characteristics of the IP.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who show symptoms of acute disease at the time of screening.&#xD;
&#xD;
          -  Subjects with any clinically significant disease related to ongoing cardiovascular&#xD;
             problem, respiratory system, kidney, endocrine system, hematologic, central nervous&#xD;
             system, mental health disorder, or malignant tumor.&#xD;
&#xD;
          -  Subjects with a history or current evidence of gastrointestinal disease which may&#xD;
             affect PK evaluation for the IP.&#xD;
&#xD;
          -  Subjects who have clinical changes to an estimated level that may affect PK evaluation&#xD;
             of the study drug within 30 days prior to the scheduled dosing date.&#xD;
&#xD;
          -  Changes in existing medications including dosage regimen within 30 days prior to the&#xD;
             scheduled dosing date.&#xD;
&#xD;
          -  Subjects with prior history or current evidence of clinically significant&#xD;
             hypersensitivity to drugs containing any ingredient of proton pump inhibitors or&#xD;
             potassium-competitive acid blockers and other drugs (such as aspirin and antibiotics).&#xD;
&#xD;
          -  Systolic BP of &lt; 90 mmHg or &gt; 160 mmHg, or diastolic BP of &lt; 50 mmHg or &gt; 100 mmHg at&#xD;
             screening.&#xD;
&#xD;
          -  Any concomitant medications or foods which may significantly affect absorption,&#xD;
             distribution, metabolism, or elimination of the study drug within 7 days prior to the&#xD;
             scheduled dosing date.&#xD;
&#xD;
          -  Subjects who have participated in any other clinical study or bioequivalence study and&#xD;
             received investigational agent within 180 days prior to scheduled study treatment.&#xD;
&#xD;
          -  Subjects who have donated whole blood within 60 days prior to the scheduled dosing&#xD;
             date, or have donated blood components or received transfusion within 30 days prior to&#xD;
             the scheduled dosing date.&#xD;
&#xD;
          -  Subjects who are unable to use medically acceptable contraceptive methods throughout&#xD;
             the study.&#xD;
&#xD;
          -  Subjects who are determined to be ineligible for study participation by the&#xD;
             investigator for other reasons.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jung-Ryul Kim, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yang-Won Min, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dong-Seong Shin, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gachon University Gil Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eon-Hye Kim, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHA Bundang Medical 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>Gachon University Gil Medical Center</name>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHA Bundang Medical Center</name>
      <address>
        <city>Seongnam-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</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 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
  </condition_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/NCT04494269
org study id: IN_APA_116
nct id: NCT04494269
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The main purpose of this study is to compare the pharmacokinetic and safety of tegoprazan
      following single oral dose in subjects with hepatic impairment versus healthy control.
[Pharmacokinetic Assessment]

        -  Measurements

           - Tegoprazan and desmethyl tegoprazan (M1) in blood and urine

        -  Endpoints

             -  Primary endpoints: AUClast and Cmax of tegoprazan and M1

             -  Secondary endpoints: CL/F, t1/2, AUCinf, and fu of tegoprazan; CLrenal and Ae of
                tegoprazan and M1

      [Safety Assessment]

        -  Adverse events (AEs)

        -  Clinical laboratory tests

        -  Vital sign

        -  Physical examination

        -  Electrocardiogram (ECG)
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pharmacokinetic Assessment
time frame: Up to 48 hours
description: AUClast of tegoprazan and M1
measure: Pharmacokinetic Assessment
time frame: Up to 48 hours
description: Cmax of tegoprazan and M1
measure: Pharmacokinetic Assessment
time frame: Up to 48 hours
description: CL/F of tegoprazan
measure: Pharmacokinetic Assessment
time frame: Up to 48 hours
description: t½ of tegoprazan
measure: Pharmacokinetic Assessment
time frame: Up to 48 hours
description: AUCinf of tegoprazan
measure: Pharmacokinetic Assessment
time frame: Up to 48 hours
description: fu of tegoprazan
measure: Pharmacokinetic Assessment
time frame: Up to 48 hours
description: CLrenal of tegoprazan and M1
measure: Pharmacokinetic Assessment
time frame: Up to 48 hours
description: Ae of tegoprazan and M1
arm group label: Subjects with normal hepatic function
arm group type: Active Comparator
description: Single dose of Tegoprazan 50mg
arm group label: Subjects with mild hepatic impairment
arm group type: Experimental
description: Single dose of Tegoprazan 50mg
arm group label: Subjects with moderate hepatic impairment
arm group type: Experimental
description: Single dose of Tegoprazan 50mg
arm group label: Subjects with severe hepatic impairment
arm group type: Experimental
description: Single dose of Tegoprazan 50mg
intervention type: Drug
intervention name: Tegoprazan 50mg
description: Oral administration once daily
arm group label: Subjects with mild hepatic impairment
arm group label: Subjects with moderate hepatic impairment
arm group label: Subjects with normal hepatic function
arm group label: Subjects with severe hepatic impairment
other name: K-CAB
criteria: 
gender: All
minimum age: 19 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jung-Ryul Kim, MD, PhD
role: Study Chair
affiliation: Samsung Medical Center
last name: Yang-Won Min, MD, PhD
role: Principal Investigator
affiliation: Samsung Medical Center
last name: Dong-Seong Shin, MD, PhD
role: Principal Investigator
affiliation: Gachon University Gil Medical Center
last name: Eon-Hye Kim, MD, PhD
role: Principal Investigator
affiliation: CHA Bundang Medical 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
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Liver Diseases