<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/NCT02231450</url>
  </required_header>
  <id_info>
    <org_study_id>15877A</org_study_id>
    <secondary_id>2013-004449-18</secondary_id>
    <nct_id>NCT02231450</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics Properties of Single Oral Dosing of Lu AE58054 in Subjects With Hepatic Impairment (Mild and Moderate) and in Healthy Subjects</brief_title>
  <official_title>Interventional, Open-label, Three-group Study to Determine the Pharmacokinetic Properties of Single Oral Dosing of Lu AE58054 in Patients With Hepatic Impairment (Mild and Moderate) and in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>H. Lundbeck A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>H. Lundbeck A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the impact of mild to moderate hepatic impairment on&#xD;
      the pharmacokinetics of Lu AE58054 following a single oral dose of Lu AE58054&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <primary_completion_date type="Actual">March 2015</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>Area under the Lu AE58054 plasma concentration-time curve from time zero to infinity (AUC0-inf)</measure>
    <time_frame>0 to 96 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum observed plasma concentration (Cmax) of Lu AE58054</measure>
    <time_frame>0 to 96 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Absolute values and changes from baseline in safety variables (Adverse events, clinical safety laboratory tests, vital signs, weight, and ECG)</measure>
    <time_frame>Screening to day 11</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Heptic Impairment</condition>
  <arm_group>
    <arm_group_label>Patients with mild hepatic impairment (Group1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8 patients with mild hepatic impairment will be administered a single oral dose of 60 mg Lu AE58054</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with moderate hepatic impairment (Group 2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8 patients with moderate hepatic impairment will be administered a single oral dose of 60 mg Lu AE58054.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy subjects (Group 3)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8 healthy subjects will be administered a single oral dose of 60 mg Lu AE58054.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lu AE58054 encapsulated film-coated tablets</intervention_name>
    <arm_group_label>Healthy subjects (Group 3)</arm_group_label>
    <arm_group_label>Patients with mild hepatic impairment (Group1)</arm_group_label>
    <arm_group_label>Patients with moderate hepatic impairment (Group 2)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women aged between 40 and 65 years (inclusive) with a body mass index between&#xD;
             19 and 32 kg/m2 (inclusive).&#xD;
&#xD;
          -  Group 1: Patients with mild hepatic impairment (Child-Pugh's Criteria A, score 5-6)&#xD;
&#xD;
          -  Group 2: Patients with moderate hepatic impairment (Child-Pugh's Criteria B, score&#xD;
             7-9)&#xD;
&#xD;
          -  Group 3: Healthy subjects with normal hepatic function&#xD;
&#xD;
        Other pre-defined inclusion and exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Email contact via H. Lundbeck A/S</last_name>
    <role>Study Director</role>
    <affiliation>LundbeckClinicalTrials@lundbeck.com</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>APEX GmbH</name>
      <address>
        <city>Munich</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>March 17, 2015</last_update_submitted>
  <last_update_submitted_qc>March 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 18, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>AE58054</keyword>
  <keyword>Hepatic impairment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>(2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine</mesh_term>
  </intervention_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/NCT02231450
org study id: 15877A
secondary id: 2013-004449-18
nct id: NCT02231450
lead sponsor: 
has dmc: No
The purpose of this study is to assess the impact of mild to moderate hepatic impairment on
      the pharmacokinetics of Lu AE58054 following a single oral dose of Lu AE58054
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the Lu AE58054 plasma concentration-time curve from time zero to infinity (AUC0-inf)
time frame: 0 to 96 hours
measure: Maximum observed plasma concentration (Cmax) of Lu AE58054
time frame: 0 to 96 hours
measure: Absolute values and changes from baseline in safety variables (Adverse events, clinical safety laboratory tests, vital signs, weight, and ECG)
time frame: Screening to day 11
arm group label: Patients with mild hepatic impairment (Group1)
arm group type: Experimental
description: 8 patients with mild hepatic impairment will be administered a single oral dose of 60 mg Lu AE58054
arm group label: Patients with moderate hepatic impairment (Group 2)
arm group type: Experimental
description: 8 patients with moderate hepatic impairment will be administered a single oral dose of 60 mg Lu AE58054.
arm group label: Healthy subjects (Group 3)
arm group type: Experimental
description: 8 healthy subjects will be administered a single oral dose of 60 mg Lu AE58054.
intervention type: Drug
intervention name: Lu AE58054 encapsulated film-coated tablets
arm group label: Healthy subjects (Group 3)
arm group label: Patients with mild hepatic impairment (Group1)
arm group label: Patients with moderate hepatic impairment (Group 2)
criteria: 
gender: All
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Email contact via H. Lundbeck A/S
role: Study Director
affiliation: LundbeckClinicalTrials@lundbeck.com
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: (2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine