<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/NCT02260830</url>
  </required_header>
  <id_info>
    <org_study_id>15911A</org_study_id>
    <secondary_id>2013-004887-77</secondary_id>
    <nct_id>NCT02260830</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic Properties of Various Modified Release Tablet Formulations of Lu AF11167</brief_title>
  <official_title>Interventional, Open-label, Part Fixed Sequence, Part-randomised Study Investigating the Pharmacokinetic Properties of up to 6 Prototype Modified Release Tablet Formulations 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 investigate the pharmacokinetic (PK) properties of various&#xD;
      modified release tablet formulations of Lu AF11167 (Part A) and to investigate the&#xD;
      pharmacokinetic (PK) properties of a modified release tablet formulation of Lu AF11167 in a&#xD;
      fed and fasted state and following multiple dosing (Part B).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <primary_completion_date type="Actual">March 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>PK parameters for Lu AF11167 estimated from the single dose treatment periods in Part A and B: Cmax, Frel, AUC0-inf, AUC0t, AUC%extr, CL/F, t½, tlag, tmax and Vz/F.</measure>
    <time_frame>0-48 hours</time_frame>
    <description>Composite analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK parameters for Lu AF11167 estimated from the multiple dose treatment period in Part B: AUC0-tau, AI (accumulation index), Cmax, Cpre, CL/F, t½, tmax and Vz/F.</measure>
    <time_frame>Up to 60 hours post dose on day 7</time_frame>
    <description>Composite analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PK parameters for Lu AF36201 estimated from the single dose treatment periods in Part A and B: Cmax, AUC0-inf, AUC0-t, AUC%extr, t½, tlag and tmax, MR (metabolic ratio).</measure>
    <time_frame>0-48 HOurs</time_frame>
    <description>Composite analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK parameters for Lu AF36201 estimated from the multiple dose treatment period in Part B: AUC0-tau, AI, Cmax, Cpre, MR, t½ and tmax.</measure>
    <time_frame>Up to 60 hours post dose day 7</time_frame>
    <description>Composite analysis</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>Up to 70 days</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Treatment Period A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 reference treatment (2 mg Lu AF11167 immediate release hard capsule) + 5 different test prototype formulations of Lu AF11167</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Period B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Food interaction and multiple dosing of Lu AF11167</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lu AF11167</intervention_name>
    <arm_group_label>Treatment Period A</arm_group_label>
    <arm_group_label>Treatment Period B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy men and women ≥18 and ≤45 years of age with a body mass index (BMI) of &gt;18.5&#xD;
             and &lt;30.0 kg/m2.&#xD;
&#xD;
          -  Women of child-bearing potential will have a confirmed non-pregnant and non-lactating&#xD;
             status.&#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>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Email contact via LundbeckClinicalTrials@Lundbeck.com</last_name>
    <role>Study Director</role>
    <affiliation>LundbeckClinicalTrials@lundbeck.com</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Quotient Clinical</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>March 4, 2015</last_update_submitted>
  <last_update_submitted_qc>March 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 6, 2015</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>Schizophrenia</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/NCT02260830
org study id: 15911A
secondary id: 2013-004887-77
nct id: NCT02260830
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the pharmacokinetic (PK) properties of various
      modified release tablet formulations of Lu AF11167 (Part A) and to investigate the
      pharmacokinetic (PK) properties of a modified release tablet formulation of Lu AF11167 in a
      fed and fasted state and following multiple dosing (Part B).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PK parameters for Lu AF11167 estimated from the single dose treatment periods in Part A and B: Cmax, Frel, AUC0-inf, AUC0t, AUC%extr, CL/F, t½, tlag, tmax and Vz/F.
time frame: 0-48 hours
description: Composite analysis
measure: PK parameters for Lu AF11167 estimated from the multiple dose treatment period in Part B: AUC0-tau, AI (accumulation index), Cmax, Cpre, CL/F, t½, tmax and Vz/F.
time frame: Up to 60 hours post dose on day 7
description: Composite analysis
measure: PK parameters for Lu AF36201 estimated from the single dose treatment periods in Part A and B: Cmax, AUC0-inf, AUC0-t, AUC%extr, t½, tlag and tmax, MR (metabolic ratio).
time frame: 0-48 HOurs
description: Composite analysis
measure: PK parameters for Lu AF36201 estimated from the multiple dose treatment period in Part B: AUC0-tau, AI, Cmax, Cpre, MR, t½ and tmax.
time frame: Up to 60 hours post dose day 7
description: Composite analysis
measure: Number of adverse events
time frame: Up to 70 days
arm group label: Treatment Period A
arm group type: Experimental
description: 1 reference treatment (2 mg Lu AF11167 immediate release hard capsule) + 5 different test prototype formulations of Lu AF11167
arm group label: Treatment Period B
arm group type: Experimental
description: Food interaction and multiple dosing of Lu AF11167
intervention type: Drug
intervention name: Lu AF11167
arm group label: Treatment Period A
arm group label: Treatment Period B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Email contact via LundbeckClinicalTrials@Lundbeck.com
role: Study Director
affiliation: LundbeckClinicalTrials@lundbeck.com
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Schizophrenia