<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/NCT04405323</url>
  </required_header>
  <id_info>
    <org_study_id>18453A</org_study_id>
    <nct_id>NCT04405323</nct_id>
  </id_info>
  <brief_title>Study That Evaluates the Effect of CYP3A4 Inhibition on Lu AG06466 in Healthy Men and Women</brief_title>
  <official_title>Interventional, Open-label, Randomized, Two-sequence Study Evaluating the Effect of CYP3A4 Inhibition on the Pharmacokinetics, Safety and Tolerability of Lu AG06466 in Healthy Men and Women</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>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study to learn how a drug (itraconazole) that is known to inhibit a certain enzym in the&#xD;
      liver, impacts the body's ability to breakdown Lu AG06466 into breakdown products in healthy&#xD;
      men and women. The main breakdown product is Lu AG06988.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two sequence study where Lu AG06466 will be dosed with and without food, Sequence 1 and&#xD;
      Sequence 2. Each subject will receive single oral doses of Lu AG06466. Subject will be&#xD;
      randomized to one of two sequences.&#xD;
&#xD;
      For inhibition of CYP3A4, each subject will receive a once daily dosage of itraconazole from&#xD;
      Day 5 to Day 11.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2020</start_date>
  <completion_date type="Actual">July 28, 2020</completion_date>
  <primary_completion_date type="Actual">July 28, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC(0-inf) Lu AG06466</measure>
    <time_frame>From 0 to 48 hours post-dose on Day 1, 3, 8 and 10</time_frame>
    <description>Area under the Lu AG06466 plasma concentration-time curve from time zero to infinity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC(0-inf) Lu AG06988</measure>
    <time_frame>From 0 to 48 hours post-dose on Day 1, 3, 8 and 10</time_frame>
    <description>Area under the Lu AG06988 plasma concentration-time curve from time zero to infinity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax Lu AG06466</measure>
    <time_frame>From 0 to 48 hours post-dose on Day 1, 3, 8 and 10</time_frame>
    <description>Maximum observed plasma concentration (Cmax) of Lu AG06466</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax Lu AG06988</measure>
    <time_frame>From 0 to 48 hours post-dose on Day 1, 3, 8 and 10</time_frame>
    <description>Maximum observed plasma concentration (Cmax) of Lu AG06988</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Lu AG06466 - Sequence 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dosing on Days 1 and 8 will be following an overnight fast, and dosing on Days 3 and 10 will be following a standard high-fat breakfast.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lu AG06466 - Sequence 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dosing on Days 1 and 8 will be following, a standard high-fat breakfast and dosing on Days 3 and 10 will be following an overnight fast.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lu AG06466</intervention_name>
    <description>hard capsules, orally, single doses</description>
    <arm_group_label>Lu AG06466 - Sequence 1</arm_group_label>
    <arm_group_label>Lu AG06466 - Sequence 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Itraconazole</intervention_name>
    <description>200 and 300 mg, capsules, orally</description>
    <arm_group_label>Lu AG06466 - Sequence 1</arm_group_label>
    <arm_group_label>Lu AG06466 - Sequence 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The subject has a BMI ≥18.5 and ≤30 kg/m2&#xD;
&#xD;
          -  The subject is, in the opinion of the investigator, generally healthy based on medical&#xD;
             history, a physical examination, a neurological examination, vital signs, an&#xD;
             electrocardiogram (ECG), and the results of the clinical chemistry, haematology,&#xD;
             urinalysis, serology, and other laboratory tests.&#xD;
&#xD;
          -  The subject must not be of childbearing potential (if a woman) or should use&#xD;
             contraception (both sexes). If women, the subject must not be pregnant or&#xD;
             breastfeeding.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject is a poor metabolizer (PM) of CYP2C9 and/or CYP2C19.&#xD;
&#xD;
        Other in- 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>US1517</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>August 13, 2020</last_update_submitted>
  <last_update_submitted_qc>August 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04405323
org study id: 18453A
nct id: NCT04405323
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
A study to learn how a drug (itraconazole) that is known to inhibit a certain enzym in the
      liver, impacts the body's ability to breakdown Lu AG06466 into breakdown products in healthy
      men and women. The main breakdown product is Lu AG06988.
Two sequence study where Lu AG06466 will be dosed with and without food, Sequence 1 and
      Sequence 2. Each subject will receive single oral doses of Lu AG06466. Subject will be
      randomized to one of two sequences.

      For inhibition of CYP3A4, each subject will receive a once daily dosage of itraconazole from
      Day 5 to Day 11.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AUC(0-inf) Lu AG06466
time frame: From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
description: Area under the Lu AG06466 plasma concentration-time curve from time zero to infinity
measure: AUC(0-inf) Lu AG06988
time frame: From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
description: Area under the Lu AG06988 plasma concentration-time curve from time zero to infinity
measure: Cmax Lu AG06466
time frame: From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
description: Maximum observed plasma concentration (Cmax) of Lu AG06466
measure: Cmax Lu AG06988
time frame: From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
description: Maximum observed plasma concentration (Cmax) of Lu AG06988
arm group label: Lu AG06466 - Sequence 1
arm group type: Experimental
description: Dosing on Days 1 and 8 will be following an overnight fast, and dosing on Days 3 and 10 will be following a standard high-fat breakfast.
arm group label: Lu AG06466 - Sequence 2
arm group type: Experimental
description: Dosing on Days 1 and 8 will be following, a standard high-fat breakfast and dosing on Days 3 and 10 will be following an overnight fast.
intervention type: Drug
intervention name: Lu AG06466
description: hard capsules, orally, single doses
arm group label: Lu AG06466 - Sequence 1
arm group label: Lu AG06466 - Sequence 2
intervention type: Drug
intervention name: Itraconazole
description: 200 and 300 mg, capsules, orally
arm group label: Lu AG06466 - Sequence 1
arm group label: Lu AG06466 - Sequence 2
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 States
responsible party type: Sponsor
mesh term: Itraconazole