<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/NCT03765671</url>
  </required_header>
  <id_info>
    <org_study_id>GFT505-118-14</org_study_id>
    <nct_id>NCT03765671</nct_id>
  </id_info>
  <brief_title>Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients</brief_title>
  <official_title>An Open-label, Phase 1, Single-dose Study to Evaluate the Pharmacokinetics of Elafibranor 120 mg in Adult Subjects With Hepatic Impairment and Adult Healthy Control Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Genfit</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Syneos Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Genfit</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being conducted in order to assess the need for dose adjustment for elafibranor&#xD;
      in patients with hepatic impairment. Pharmacokinetic parameters of elafibranor and its active&#xD;
      metabolite (GFT1007) will be compared in hepatic impaired patients (mild, moderate and severe&#xD;
      according to Child-Pugh categories) versus healthy participants after a single oral&#xD;
      administration of elafibranor 120 mg.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2018</start_date>
  <completion_date type="Actual">June 14, 2019</completion_date>
  <primary_completion_date type="Actual">June 7, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under curve from dosing time to last measurement (AUC(0-t)) of elafibranor and active metabolite</measure>
    <time_frame>pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired patients</time_frame>
    <description>In participants with mild, moderate and severe hepatic impairment compared to healthy volunteers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under curve from dosing time to infinity (AUC(0-∞)) of elafibranor and active metabolite</measure>
    <time_frame>pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired patients</time_frame>
    <description>In participants with mild, moderate and severe hepatic impairment compared to healthy volunteers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma pharmacokinetics: maximum plasma drug concentration (Cmax)</measure>
    <time_frame>pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired participants</time_frame>
    <description>for elafibranor and metabolites</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma pharmacokinetics: elimination half-life (t1/2)</measure>
    <time_frame>pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired participants</time_frame>
    <description>for elafibranor and metabolites</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma pharmacokinetics: apparent volume of distribution (Vd/F)</measure>
    <time_frame>pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired participants</time_frame>
    <description>for elafibranor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma pharmacokinetics: renal clearance (CLr)</measure>
    <time_frame>pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired participants</time_frame>
    <description>for elafibranor and metabolites</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma pharmacokinetics: apparent non renal clearance (CLnr/F)</measure>
    <time_frame>pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired participants</time_frame>
    <description>for elafibranor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma pharmacokinetics: apparent total clearance (CL/F)</measure>
    <time_frame>pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired participants</time_frame>
    <description>for elafibranor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma pharmacokinetics: area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total area under the plasma concentration-time curve (%AUCextra)</measure>
    <time_frame>pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired participants</time_frame>
    <description>for elafibranor and metabolites</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma pharmacokinetics: area under curve from dosing time to last measurement (AUC(0-t)) of glucuronide metabolites and corresponding aglycones</measure>
    <time_frame>pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired participants</time_frame>
    <description>for the glucuronide metabolites of elafibranor and corresponding aglycones</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma pharmacokinetics: area under curve from dosing time to infinity (AUC(0-∞)) of glucuronide metabolites and corresponding aglycones</measure>
    <time_frame>pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired patients</time_frame>
    <description>for the glucuronide metabolites of elafibranor and corresponding aglycones</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine pharmacokinetics: amount excreted (Ae)</measure>
    <time_frame>pre-dose and then 24, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose</time_frame>
    <description>for elafibranor and metabolites, if applicable. 24 hours urine collection from dosing to 216 hours post-dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine pharmacokinetics: cumulative amount excreted (Ae0-t)</measure>
    <time_frame>pre-dose and then 24, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose</time_frame>
    <description>for elafibranor and metabolites, if applicable. 24 hours urine collection from dosing to 216 hours post-dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine pharmacokinetics: percentage of dose excreted (Fe)</measure>
    <time_frame>pre-dose and then 24, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose</time_frame>
    <description>for elafibranor and metabolites, if applicable. 24 hours urine collection from dosing to 216 hours post-dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine pharmacokinetics: cumulative percent of dose excreted (Fe0-t)</measure>
    <time_frame>pre-dose and then 24, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose</time_frame>
    <description>for elafibranor and metabolites, if applicable. 24 hours urine collection from dosing to 216 hours post-dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine pharmacokinetics: renal clearance (CLR)</measure>
    <time_frame>pre-dose and then 24, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose</time_frame>
    <description>for elafibranor and metabolites, if applicable. 24 hours urine collection from dosing to 216 hours post-dose</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Hepatic Impairment</condition>
  <condition>Liver Disease</condition>
  <condition>Pharmacokinetics</condition>
  <arm_group>
    <arm_group_label>Mild Child-Pugh A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of elafibranor 120mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate Child-Pugh B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of elafibranor 120mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Severe Child-Pugh C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of elafibranor 120mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose of elafibranor 120mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Elafibranor</intervention_name>
    <description>120mg oral single dose</description>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_label>Mild Child-Pugh A</arm_group_label>
    <arm_group_label>Moderate Child-Pugh B</arm_group_label>
    <arm_group_label>Severe Child-Pugh C</arm_group_label>
    <other_name>GFT505</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - For all participants:&#xD;
&#xD;
          1. Males or females, between 18 and 75 years of age, inclusive;&#xD;
&#xD;
          2. With a minimum body weight of 50 kg and within a BMI range of 18.0 to 40.0 kg/m²,&#xD;
             inclusive;&#xD;
&#xD;
          3. Females participating in this study must be of non-childbearing potential or using&#xD;
             highly efficient contraception for the full duration of the study&#xD;
&#xD;
          4. Negative serum pregnancy test at screening (if applicable);&#xD;
&#xD;
          5. Negative human immunodeficiency virus antibody screens at Screening;&#xD;
&#xD;
               -  For hepatically impaired participants:&#xD;
&#xD;
          6. Participants who have chronic (≥ 6 months) mild, moderate, or severe hepatic&#xD;
             insufficiency (of any etiology) that has been clinically stable (no acute episodes of&#xD;
             illness due to deterioration in hepatic function) for at least 1 month prior to&#xD;
             Screening Currently on a stable medication regimen&#xD;
&#xD;
               -  For healthy volunteers with normal hepatic function:&#xD;
&#xD;
          7. Non-smokers&#xD;
&#xD;
          8. Matched to participants with Mild and/or Moderate and/or Severe hepatic impairment in&#xD;
             age (± 10 years), BMI (± 20 percent) and gender.&#xD;
&#xD;
        Other protocol-defined inclusion criteria may apply&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - For all participants:&#xD;
&#xD;
          1. A positive alcohol test result at Check-in;&#xD;
&#xD;
          2. A history of alcohol abuse in the prior 2 years;&#xD;
&#xD;
          3. Positive urine screen for drugs of abuse at Screening or Check-in.&#xD;
&#xD;
          4. Strenuous exercise within 72 hours prior to Check-in;&#xD;
&#xD;
          5. Blood donation or loss of blood (excluding volume drawn at screening or menses) of 50&#xD;
             mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the&#xD;
             dosing;&#xD;
&#xD;
          6. History of stomach or intestinal surgery or resection that would potentially alter&#xD;
             absorption and/or excretion of orally administered drugs except that appendectomy and&#xD;
             hernia repair will be allowed. Bariatric surgery will not be allowed.&#xD;
&#xD;
          7. Presence or history of malignancy within the prior 3 years, with the exception of&#xD;
             treated basal cell or squamous cell carcinoma;&#xD;
&#xD;
          8. Poor peripheral venous access;&#xD;
&#xD;
          9. Receipt of blood products within 2 months prior to Check-in;&#xD;
&#xD;
               -  For hepatically impaired participants:&#xD;
&#xD;
         10. History of unstable diabetes mellitus Subjects who have a transjugular intrahepatic&#xD;
             portosystemic shunt and/or have undergone portacaval shunting;&#xD;
&#xD;
         11. Participant has shown evidence of hepatorenal syndrome or has creatinine clearance ≤&#xD;
             60 mL/min Subject has required treatment for GI bleeding within the 6 months prior to&#xD;
             Check in;&#xD;
&#xD;
         12. Recent history of paracentesis (&lt; 3 months prior to Check-in);&#xD;
&#xD;
         13. Participants with Wilson's disease, alpha-1 antitrypsin deficiency, glycogen storage&#xD;
             diseases, or galactosemia;&#xD;
&#xD;
         14. Participants with anemia secondary to hepatic disease, unless hemoglobin is ≥ 9 g/dL&#xD;
             and anemia symptoms are not clinically significant. Subjects must have ≥ 35 000&#xD;
             platelets at screening and at Day -1;&#xD;
&#xD;
               -  For healthy volunteers with normal hepatic function:&#xD;
&#xD;
         15. Significant history or clinical manifestation of any metabolic (including thyroid),&#xD;
             allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular&#xD;
             (including any prior history of cardiomyopathy or cardiac failure), gastrointestinal&#xD;
             (GI), neurological, or psychiatric disorder;&#xD;
&#xD;
         16. Positive serologic test for hepatitis B surface antigen or for hepatitis C virus&#xD;
             antibody at Screening;&#xD;
&#xD;
         17. Frequent headaches (&gt; twice a month) and/or migraines, recurrent nausea and/or&#xD;
             vomiting;&#xD;
&#xD;
         18. Participants with symptomatic hypotension at Screening, whatever the decrease of blood&#xD;
             pressure, or asymptomatic postural hypotension;&#xD;
&#xD;
         19. Cholecystectomy&#xD;
&#xD;
        Other protocol-defined exclusion criteria may apply&#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>Pascal BIRMAN, MD</last_name>
    <role>Study Director</role>
    <affiliation>Genfit</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Division of Clinical Pharmacology, University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>inVentiv Health Clinical Research</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>August 21, 2019</last_update_submitted>
  <last_update_submitted_qc>August 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2019</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/NCT03765671
org study id: GFT505-118-14
nct id: NCT03765671
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study is being conducted in order to assess the need for dose adjustment for elafibranor
      in patients with hepatic impairment. Pharmacokinetic parameters of elafibranor and its active
      metabolite (GFT1007) will be compared in hepatic impaired patients (mild, moderate and severe
      according to Child-Pugh categories) versus healthy participants after a single oral
      administration of elafibranor 120 mg.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Area under curve from dosing time to last measurement (AUC(0-t)) of elafibranor and active metabolite
time frame: pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired patients
description: In participants with mild, moderate and severe hepatic impairment compared to healthy volunteers
measure: Area under curve from dosing time to infinity (AUC(0-∞)) of elafibranor and active metabolite
time frame: pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired patients
description: In participants with mild, moderate and severe hepatic impairment compared to healthy volunteers
measure: Plasma pharmacokinetics: maximum plasma drug concentration (Cmax)
time frame: pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired participants
description: for elafibranor and metabolites
measure: Plasma pharmacokinetics: elimination half-life (t1/2)
time frame: pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired participants
description: for elafibranor and metabolites
measure: Plasma pharmacokinetics: apparent volume of distribution (Vd/F)
time frame: pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired participants
description: for elafibranor
measure: Plasma pharmacokinetics: renal clearance (CLr)
time frame: pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired participants
description: for elafibranor and metabolites
measure: Plasma pharmacokinetics: apparent non renal clearance (CLnr/F)
time frame: pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired participants
description: for elafibranor
measure: Plasma pharmacokinetics: apparent total clearance (CL/F)
time frame: pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired participants
description: for elafibranor
measure: Plasma pharmacokinetics: area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total area under the plasma concentration-time curve (%AUCextra)
time frame: pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired participants
description: for elafibranor and metabolites
measure: Plasma pharmacokinetics: area under curve from dosing time to last measurement (AUC(0-t)) of glucuronide metabolites and corresponding aglycones
time frame: pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired participants
description: for the glucuronide metabolites of elafibranor and corresponding aglycones
measure: Plasma pharmacokinetics: area under curve from dosing time to infinity (AUC(0-∞)) of glucuronide metabolites and corresponding aglycones
time frame: pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired patients
description: for the glucuronide metabolites of elafibranor and corresponding aglycones
measure: Urine pharmacokinetics: amount excreted (Ae)
time frame: pre-dose and then 24, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose
description: for elafibranor and metabolites, if applicable. 24 hours urine collection from dosing to 216 hours post-dose
measure: Urine pharmacokinetics: cumulative amount excreted (Ae0-t)
time frame: pre-dose and then 24, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose
description: for elafibranor and metabolites, if applicable. 24 hours urine collection from dosing to 216 hours post-dose
measure: Urine pharmacokinetics: percentage of dose excreted (Fe)
time frame: pre-dose and then 24, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose
description: for elafibranor and metabolites, if applicable. 24 hours urine collection from dosing to 216 hours post-dose
measure: Urine pharmacokinetics: cumulative percent of dose excreted (Fe0-t)
time frame: pre-dose and then 24, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose
description: for elafibranor and metabolites, if applicable. 24 hours urine collection from dosing to 216 hours post-dose
measure: Urine pharmacokinetics: renal clearance (CLR)
time frame: pre-dose and then 24, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose
description: for elafibranor and metabolites, if applicable. 24 hours urine collection from dosing to 216 hours post-dose
arm group label: Mild Child-Pugh A
arm group type: Experimental
description: Single oral dose of elafibranor 120mg
arm group label: Moderate Child-Pugh B
arm group type: Experimental
description: Single oral dose of elafibranor 120mg
arm group label: Severe Child-Pugh C
arm group type: Experimental
description: Single oral dose of elafibranor 120mg
arm group label: Healthy
arm group type: Experimental
description: Single oral dose of elafibranor 120mg
intervention type: Drug
intervention name: Elafibranor
description: 120mg oral single dose
arm group label: Healthy
arm group label: Mild Child-Pugh A
arm group label: Moderate Child-Pugh B
arm group label: Severe Child-Pugh C
other name: GFT505
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pascal BIRMAN, MD
role: Study Director
affiliation: Genfit
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Liver Diseases