<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/NCT02199431</url>
  </required_header>
  <id_info>
    <org_study_id>14380A</org_study_id>
    <secondary_id>2013-003870-28</secondary_id>
    <nct_id>NCT02199431</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Effect of a Known and Marketed Product, Itraconazole (Mycosis Treatment) on Lu AF11167 Entering the Body and Subsequently Elimination. The Study is a Drug-drug Interaction Study in Healthy Volunteers.</brief_title>
  <official_title>Interventional, Open-label, Interaction Study Investigating the Effects of Itraconazole (Inhibitor of CYP3A4/5) on the Pharmacokinetics and Safety and Tolerability of Lu AF11167 in Healthy Young 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 evaluate the increase in exposure of Lu AF11167 following a&#xD;
      single oral dose of Lu AF11167 with and without administration of multiple oral doses of&#xD;
      itraconazole (a strong CYP3A4/5 inhibitor) in healthy subjects with inferred metabolic status&#xD;
      as CYP2C19 extensive metabolisers&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <primary_completion_date type="Actual">February 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 AF11167 plasma concentration-time curve from zero to infinity (AUC0-inf)</measure>
    <time_frame>Day 1 and 8</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum observed plasma concentration (Cmax) of Lu AF11167</measure>
    <time_frame>Day 1 and 8</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the Lu AF36201 plasma concentration-time curve from zero to infinity (AUC0-inf)</measure>
    <time_frame>Day 1 and 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum observed plasma concentration (Cmax) of Lu AF36201</measure>
    <time_frame>Day 1 and 8</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Lu AF1167 capsule 0.5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single oral dose (day 1)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lu AF11167 0.5 mg capsule + itraconazole 200 mg capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Itraconazole administered once daily for 7 days (day 3-9); Lu AF11167 administered as a single dose on day 8</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lu AF11167</intervention_name>
    <arm_group_label>Lu AF11167 0.5 mg capsule + itraconazole 200 mg capsule</arm_group_label>
    <arm_group_label>Lu AF1167 capsule 0.5 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Itraconazole</intervention_name>
    <arm_group_label>Lu AF11167 0.5 mg capsule + itraconazole 200 mg capsule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects be 18 years of age and 55 years of age and with a BMI &gt;18.5 kg/m2 and &lt;30.0&#xD;
             kg/m2 at the Screening Visit. Women must not be pregnant or lactating.&#xD;
&#xD;
        Other pre-defined inclusion and exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 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>Covance</name>
      <address>
        <city>Leeds</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>September 18, 2015</last_update_submitted>
  <last_update_submitted_qc>September 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lu AF11167</keyword>
  <keyword>Interaction</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Itraconazole</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/NCT02199431
org study id: 14380A
secondary id: 2013-003870-28
nct id: NCT02199431
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the increase in exposure of Lu AF11167 following a
      single oral dose of Lu AF11167 with and without administration of multiple oral doses of
      itraconazole (a strong CYP3A4/5 inhibitor) in healthy subjects with inferred metabolic status
      as CYP2C19 extensive metabolisers
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the Lu AF11167 plasma concentration-time curve from zero to infinity (AUC0-inf)
time frame: Day 1 and 8
measure: Maximum observed plasma concentration (Cmax) of Lu AF11167
time frame: Day 1 and 8
measure: Area under the Lu AF36201 plasma concentration-time curve from zero to infinity (AUC0-inf)
time frame: Day 1 and 8
measure: Maximum observed plasma concentration (Cmax) of Lu AF36201
time frame: Day 1 and 8
arm group label: Lu AF1167 capsule 0.5 mg
arm group type: Experimental
description: Single oral dose (day 1)
arm group label: Lu AF11167 0.5 mg capsule + itraconazole 200 mg capsule
arm group type: Experimental
description: Itraconazole administered once daily for 7 days (day 3-9); Lu AF11167 administered as a single dose on day 8
intervention type: Drug
intervention name: Lu AF11167
arm group label: Lu AF11167 0.5 mg capsule + itraconazole 200 mg capsule
arm group label: Lu AF1167 capsule 0.5 mg
intervention type: Drug
intervention name: Itraconazole
arm group label: Lu AF11167 0.5 mg capsule + itraconazole 200 mg capsule
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Email contact via H. Lundbeck A/S
role: Study Director
affiliation: LundbeckClinicalTrials@Lundbeck.com
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Itraconazole