<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/NCT03802786</url>
  </required_header>
  <id_info>
    <org_study_id>PXL008-024</org_study_id>
    <nct_id>NCT03802786</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects</brief_title>
  <official_title>An Open-label, Single-dose, Parallel-group Study to Assess the Pharmacokinetics of Imeglimin in Subjects With Moderate Hepatic Impairment Compared to Matched Healthy Control Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poxel SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poxel SA</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>
      This is a Phase 1, single-centre, open-label, parallel-group study in subjects with moderate&#xD;
      hepatic impairment and subjects with normal hepatic function. Child-Pugh (CP) scoring will be&#xD;
      used to determine hepatic impairment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 6, 2018</start_date>
  <completion_date type="Actual">July 8, 2019</completion_date>
  <primary_completion_date type="Actual">July 3, 2019</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PK parameters of imeglimin</measure>
    <time_frame>At Day 1</time_frame>
    <description>Cmax: peak plasma concentration after dosing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PK parameters of imeglimin</measure>
    <time_frame>From day 1 to day 2</time_frame>
    <description>AUC last:area under the concentration-time curve</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</measure>
    <time_frame>From day 1 to day 7</time_frame>
    <description>Incidence of Treatment-Emergent Adverse Events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Hepatic Impairment</condition>
  <arm_group>
    <arm_group_label>Moderate hepatic impairment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of Imeglimin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal hepatic function</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of Imeglimin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Imeglimin</intervention_name>
    <description>Single administration dose of imeglimin</description>
    <arm_group_label>Moderate hepatic impairment</arm_group_label>
    <arm_group_label>Normal hepatic function</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Caucasian&#xD;
&#xD;
          -  BMI :18.0 and 40.0 kg/m2 and weight ≥50 kg.&#xD;
&#xD;
          -  Stable hepatic impairment or normal hepatic function for healthy volunteer&#xD;
&#xD;
          -  No clinically significant findings from medical history, physical examination, 12-lead&#xD;
             ECG, vital sign measurements, and clinical laboratory evaluations (Subjects with&#xD;
             moderate hepatic impairment may have medical findings consistent with their hepatic&#xD;
             dysfunction)&#xD;
&#xD;
          -  Females will not be pregnant or lactating, and females of childbearing potential and&#xD;
             males will agree to use contraception&#xD;
&#xD;
          -  Informed consent signature&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically relevant abnormal findings at the screening assessment&#xD;
&#xD;
          -  Severe adverse reaction to any drug or sensitivity to the trial medication or its&#xD;
             componentsClinically significant vital signs outside the acceptable range at screening&#xD;
&#xD;
          -  History of stomach or intestinal surgery or resection that would potentially alter&#xD;
             absorption and/or excretion of orally administered drugs&#xD;
&#xD;
          -  Drug or alcohol abuse&#xD;
&#xD;
          -  Positive test HIV&#xD;
&#xD;
          -  Smoking more than 10 cig/day&#xD;
&#xD;
          -  Participation in other clinical trials of unlicensed or prescription medicines&#xD;
&#xD;
        Exclusion criteria for healthy volunteer&#xD;
&#xD;
          -  Positive test for HBV, HBC&#xD;
&#xD;
          -  eGFR less than 90 mL/min/1.73 m2&#xD;
&#xD;
          -  liver diseases&#xD;
&#xD;
        Exclusion criteria for hepatic impaired&#xD;
&#xD;
          -  eGFR less than 80 mL/min/1.73 m2&#xD;
&#xD;
          -  Hepatic impairment due to non liver disease&#xD;
&#xD;
          -  History of hepatocellular carcinoma or acute liver disease&#xD;
&#xD;
          -  CLinically significant change in liver disease status within 6 months&#xD;
&#xD;
          -  ascites&#xD;
&#xD;
          -  encephalopathy grade III or IV&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clémence Chevalier</last_name>
    <role>Study Director</role>
    <affiliation>Poxel SA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Apex</name>
      <address>
        <city>Munich</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>August 10, 2020</last_update_submitted>
  <last_update_submitted_qc>August 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pharmacokinetics</keyword>
  <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/NCT03802786
org study id: PXL008-024
nct id: NCT03802786
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a Phase 1, single-centre, open-label, parallel-group study in subjects with moderate
      hepatic impairment and subjects with normal hepatic function. Child-Pugh (CP) scoring will be
      used to determine hepatic impairment.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PK parameters of imeglimin
time frame: At Day 1
description: Cmax: peak plasma concentration after dosing
measure: PK parameters of imeglimin
time frame: From day 1 to day 2
description: AUC last:area under the concentration-time curve
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
time frame: From day 1 to day 7
description: Incidence of Treatment-Emergent Adverse Events
arm group label: Moderate hepatic impairment
arm group type: Experimental
description: Single dose of Imeglimin
arm group label: Normal hepatic function
arm group type: Experimental
description: Single dose of Imeglimin
intervention type: Drug
intervention name: Imeglimin
description: Single administration dose of imeglimin
arm group label: Moderate hepatic impairment
arm group label: Normal hepatic function
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Clémence Chevalier
role: Study Director
affiliation: Poxel SA
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Liver Diseases