<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/NCT03241147</url>
  </required_header>
  <id_info>
    <org_study_id>17278A</org_study_id>
    <nct_id>NCT03241147</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of Lu AF35700 in Subjects With Renal Impairment</brief_title>
  <official_title>Interventional, Open Label, Reduced/Staged, Single Dose Study Investigating the Pharmacokinetic Properties of Lu AF35700 in Subjects With Renal Impairment 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the pharmacokinetics of Lu AF35700 after a single dose tablet to&#xD;
      subjects with renal impairment (kidney insufficiency) and compare that with healthy subjects&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      If the initial data shows a substantial effect in subjects with severe renal impairment, the&#xD;
      study will be expanded to include subjects with intermediate level (mild and moderate) of&#xD;
      renal impairment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    New data; the study was terminated based on new efficacy data&#xD;
  </why_stopped>
  <start_date type="Actual">July 25, 2017</start_date>
  <completion_date type="Actual">July 24, 2019</completion_date>
  <primary_completion_date type="Actual">July 17, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC0-inf</measure>
    <time_frame>Predose to day 57 postdose</time_frame>
    <description>Area under the Lu AF35700 plasma concentration-time curve from zero to infinity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>Predose to day 57 postdose</time_frame>
    <description>Maximum observed plasma concentration of Lu AF35700</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Renal Failure</condition>
  <arm_group>
    <arm_group_label>Subjects with severe renal impairment (Group A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy subjects (Group B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects with moderate renal impairment (Group C)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects with mild renal impairment (Group D)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lu AF35700</intervention_name>
    <description>Single dose, 10 mg film coated tablet</description>
    <arm_group_label>Healthy subjects (Group B)</arm_group_label>
    <arm_group_label>Subjects with mild renal impairment (Group D)</arm_group_label>
    <arm_group_label>Subjects with moderate renal impairment (Group C)</arm_group_label>
    <arm_group_label>Subjects with severe renal impairment (Group A)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Healthy subjects: The subject has a Glomerular Filtration Rate as based on creatinine&#xD;
        clearance (CLCr) ≥90 mL/min (estimated by the Cockcroft-Gault method)&#xD;
&#xD;
        -Subjects with renal impairment: The subject has any form of renal dysfunction which&#xD;
        includes polycystic kidney disease&#xD;
&#xD;
        The subject is classified as having renal impairment at Screening according to&#xD;
        Cockroft-Gault method for estimating creatinine clearance:&#xD;
&#xD;
        Severe: CLCr ≤ 29 mL/min Moderate: 30 mL/min ≤ CLCr ≤ 59 mL/min Mild: 60 mL/min ≤ CLCr ≤ 89&#xD;
        mL/min&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -The subject has previously been dosed with Lu AF35700&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 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</name>
      <address>
        <city>Munich</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>September 26, 2019</last_update_submitted>
  <last_update_submitted_qc>September 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 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>Renal Insufficiency</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/NCT03241147
org study id: 17278A
nct id: NCT03241147
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will evaluate the pharmacokinetics of Lu AF35700 after a single dose tablet to
      subjects with renal impairment (kidney insufficiency) and compare that with healthy subjects
If the initial data shows a substantial effect in subjects with severe renal impairment, the
      study will be expanded to include subjects with intermediate level (mild and moderate) of
      renal impairment.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC0-inf
time frame: Predose to day 57 postdose
description: Area under the Lu AF35700 plasma concentration-time curve from zero to infinity
measure: Cmax
time frame: Predose to day 57 postdose
description: Maximum observed plasma concentration of Lu AF35700
arm group label: Subjects with severe renal impairment (Group A)
arm group type: Experimental
arm group label: Healthy subjects (Group B)
arm group type: Experimental
arm group label: Subjects with moderate renal impairment (Group C)
arm group type: Experimental
arm group label: Subjects with mild renal impairment (Group D)
arm group type: Experimental
intervention type: Drug
intervention name: Lu AF35700
description: Single dose, 10 mg film coated tablet
arm group label: Healthy subjects (Group B)
arm group label: Subjects with mild renal impairment (Group D)
arm group label: Subjects with moderate renal impairment (Group C)
arm group label: Subjects with severe renal impairment (Group A)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 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: Renal Insufficiency