<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/NCT04419636</url>
  </required_header>
  <id_info>
    <org_study_id>18454A</org_study_id>
    <nct_id>NCT04419636</nct_id>
  </id_info>
  <brief_title>Binding of Lu AG06466 in the Brain in Healthy Men</brief_title>
  <official_title>Interventional, Open-label, Position Emission Tomography (PET) Study Investigating MAGL Occupancy After Single and Multiple Oral Doses of Lu AG06466 in Healthy Male 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study to learn how Lu AG06466 and one of its break down products binds in the brain after&#xD;
      single and repeated dosing&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted in two Parts. Part A: cross over, fed/fasted determined by&#xD;
      randomized sequence Part B: sequential group&#xD;
&#xD;
      PET scans will be used to quantify MAGL occupancy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 29, 2020</start_date>
  <completion_date type="Actual">February 16, 2021</completion_date>
  <primary_completion_date type="Actual">February 9, 2021</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Central monoacylglycerol lipase (MAGL) occupancy</measure>
    <time_frame>From dosing to 8 hours post-dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>C(PET)</measure>
    <time_frame>From zero to Day 10</time_frame>
    <description>Average plasma concentration for Lu AG06466 and Lu AG06988 during PET imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC (0-24)</measure>
    <time_frame>From zero to 24 hours post-dose</time_frame>
    <description>Area under the plasma concentration curve for Lu AG06466 and Lu AG06988 from zero to 24 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax</measure>
    <time_frame>From zero to 24 hours post-dose</time_frame>
    <description>Maximum observed plasma concentration for Lu AG06466 and Lu AG06988</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Part A Single doses</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lu AG06466 in fast and fed state</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B Repeated doses</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lu AG06466 after light meal</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lu AG06466</intervention_name>
    <description>capsules, orally</description>
    <arm_group_label>Part A Single doses</arm_group_label>
    <arm_group_label>Part B Repeated doses</arm_group_label>
    <other_name>ABX-1431</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  body weight ≥60 kg.&#xD;
&#xD;
          -  body mass index ≥18.5 and ≤27 kg/m2.&#xD;
&#xD;
          -  waist circumference ≤94 cm.&#xD;
&#xD;
          -  The subject has a normal sMRI performed during the screening period.&#xD;
&#xD;
          -  The subject is suitable for radial artery blood sampling and cannulation as&#xD;
             demonstrated by the Allen test.&#xD;
&#xD;
          -  Subject must be healthy as assessed using detailed medical history, laboratory tests,&#xD;
             and physical examination.&#xD;
&#xD;
          -  The subject must make use of contraception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject is left handed.&#xD;
&#xD;
        Other in- and exclusion criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 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>UZ Leuven campus Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>February 23, 2021</last_update_submitted>
  <last_update_submitted_qc>February 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04419636
org study id: 18454A
nct id: NCT04419636
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A study to learn how Lu AG06466 and one of its break down products binds in the brain after
      single and repeated dosing
The study will be conducted in two Parts. Part A: cross over, fed/fasted determined by
      randomized sequence Part B: sequential group

      PET scans will be used to quantify MAGL occupancy
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Central monoacylglycerol lipase (MAGL) occupancy
time frame: From dosing to 8 hours post-dose
measure: C(PET)
time frame: From zero to Day 10
description: Average plasma concentration for Lu AG06466 and Lu AG06988 during PET imaging
measure: AUC (0-24)
time frame: From zero to 24 hours post-dose
description: Area under the plasma concentration curve for Lu AG06466 and Lu AG06988 from zero to 24 hours
measure: Cmax
time frame: From zero to 24 hours post-dose
description: Maximum observed plasma concentration for Lu AG06466 and Lu AG06988
arm group label: Part A Single doses
arm group type: Experimental
description: Lu AG06466 in fast and fed state
arm group label: Part B Repeated doses
arm group type: Experimental
description: Lu AG06466 after light meal
intervention type: Drug
intervention name: Lu AG06466
description: capsules, orally
arm group label: Part A Single doses
arm group label: Part B Repeated doses
other name: ABX-1431
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Email contact via H. Lundbeck A/S
role: Study Director
affiliation: LundbeckClinicalTrials@Lundbeck.com
facility: 
country: Belgium
responsible party type: Sponsor
sharing ipd: Undecided