<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/NCT04473651</url>
  </required_header>
  <id_info>
    <org_study_id>18452A</org_study_id>
    <nct_id>NCT04473651</nct_id>
  </id_info>
  <brief_title>Safety and Tolerability of Lu AG06479 in Healthy Young Men</brief_title>
  <official_title>Interventional, Randomized, Double-blind, Placebo-controlled, Sequential-group, Single-ascending Oral Dose Study Investigating the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Properties of Lu AG06479 and Open-label Cross-over Study to Investigate Intra-subject Variability and Effect of Food in Healthy Young Men</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>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the safety and tolerability of Lu AG06479 and&#xD;
      what the body does to Lu AG06479 after swallowing single doses of the drug.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Part A: randomized, sequential&#xD;
&#xD;
      Part B: open-label, cross-over&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was terminated for strategic reasons.&#xD;
  </why_stopped>
  <start_date type="Actual">July 9, 2020</start_date>
  <completion_date type="Actual">November 10, 2021</completion_date>
  <primary_completion_date type="Actual">November 10, 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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with treatment emergent adverse events (Safety and Tolerability)</measure>
    <time_frame>From baseline to Day 9 (Part A and B)</time_frame>
    <description>Based on the safety assessments (e.g. clinical safety laboratory tests, vital signs, weight and ECG parameters)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC (0-inf) of Lu AG06479</measure>
    <time_frame>From pre-dose to Day 5 (Part A and B)</time_frame>
    <description>Area under the Lu AG06479 concentration-time curve from time zero to infinity (AUC0-inf)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F Lu AG06479</measure>
    <time_frame>From pre-dose to Day 5 (Part A and B)</time_frame>
    <description>Oral clearance of Lu AG06479</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax Lu AG06479</measure>
    <time_frame>From pre-dose to Day 5 (Part A and B)</time_frame>
    <description>Maximum observed plasma concentration for Lu AG06479</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Part A: Single dose of Lu AG06479 or Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: Repeated dose of Lu AG06479 and Food interaction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sequence B1: Fed - Fasting - Fasting&#xD;
Sequence B2: Fasting- Fed - Fasting&#xD;
Sequence B3: Fasting- Fasting - Fed</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lu AG06479</intervention_name>
    <description>capsules, orally (Part A and B)</description>
    <arm_group_label>Part A: Single dose of Lu AG06479 or Placebo</arm_group_label>
    <arm_group_label>Part B: Repeated dose of Lu AG06479 and Food interaction</arm_group_label>
    <other_name>ABX-1762</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Placebo - capsules, orally (Part A only)</description>
    <arm_group_label>Part A: Single dose of Lu AG06479 or Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy, young, non-smoking men, weight ≥60 kg, and a body mass index (BMI) ≥18.5&#xD;
             kg/m2 and ≤30 kg/m2 at the Screening Visit.&#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>Covance</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>November 30, 2021</last_update_submitted>
  <last_update_submitted_qc>November 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04473651
org study id: 18452A
nct id: NCT04473651
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to investigate the safety and tolerability of Lu AG06479 and
      what the body does to Lu AG06479 after swallowing single doses of the drug.
Part A: randomized, sequential

      Part B: open-label, cross-over
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of participants with treatment emergent adverse events (Safety and Tolerability)
time frame: From baseline to Day 9 (Part A and B)
description: Based on the safety assessments (e.g. clinical safety laboratory tests, vital signs, weight and ECG parameters)
measure: AUC (0-inf) of Lu AG06479
time frame: From pre-dose to Day 5 (Part A and B)
description: Area under the Lu AG06479 concentration-time curve from time zero to infinity (AUC0-inf)
measure: CL/F Lu AG06479
time frame: From pre-dose to Day 5 (Part A and B)
description: Oral clearance of Lu AG06479
measure: Cmax Lu AG06479
time frame: From pre-dose to Day 5 (Part A and B)
description: Maximum observed plasma concentration for Lu AG06479
arm group label: Part A: Single dose of Lu AG06479 or Placebo
arm group type: Experimental
arm group label: Part B: Repeated dose of Lu AG06479 and Food interaction
arm group type: Experimental
description: Sequence B1: Fed - Fasting - Fasting
Sequence B2: Fasting- Fed - Fasting
Sequence B3: Fasting- Fasting - Fed
intervention type: Drug
intervention name: Lu AG06479
description: capsules, orally (Part A and B)
arm group label: Part A: Single dose of Lu AG06479 or Placebo
arm group label: Part B: Repeated dose of Lu AG06479 and Food interaction
other name: ABX-1762
intervention type: Drug
intervention name: Placebos
description: Placebo - capsules, orally (Part A only)
arm group label: Part A: Single dose of Lu AG06479 or Placebo
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: United States
responsible party type: Sponsor