<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/NCT03826134</url>
  </required_header>
  <id_info>
    <org_study_id>18039A</org_study_id>
    <nct_id>NCT03826134</nct_id>
  </id_info>
  <brief_title>A Positron Emission Tomography (PET) Study to Examine the Brain Binding Properties of a Novel Radioactive Compound [11C]-PXT012253 in Healthy Subjects</brief_title>
  <official_title>Interventional, Phase I, Open-label, First in Human, Single-center Positron Emission Tomography (PET) Study Investigating Test-retest Properties of [11C]-PXT012253 as a Radiotracer in Healthy 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the usefulness of a PET radioligand to estimate the binding on the mGlu4&#xD;
      receptor in the brain. mGlu4 has been proposed as a therapeutic target in Parkinson's&#xD;
      disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2019</start_date>
  <completion_date type="Actual">March 15, 2019</completion_date>
  <primary_completion_date type="Actual">March 15, 2019</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total distribution volumes (VT) for each region of interest (ROI)</measure>
    <time_frame>Up to 3 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Binding potential (BPND) in the ROI's</measure>
    <time_frame>Up to 3 days</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>[11C]-PXT012253</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[11C]PXT012253</intervention_name>
    <description>Single intravenous bolus injection. The injected amount will be less than 5 μg. The radioactive dose is approximately 400 MBq per 70 kg body weight.</description>
    <arm_group_label>[11C]-PXT012253</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects age 20-50 inclusive&#xD;
&#xD;
          -  Body mass index (BMI) between 19 and 30 kg/m2&#xD;
&#xD;
          -  Normal sMRI scan, performed within 3 months, as judged by the investigator&#xD;
&#xD;
          -  The subject is, in the opinion of the investigator, generally healthy based on&#xD;
             assessment of medical history, physical examination, vital signs, ECG, and the results&#xD;
             of the hematology, clinical chemistry, urinalysis, serology, and other laboratory&#xD;
             tests&#xD;
&#xD;
          -  Women of childbearing potential and men whose partner is of child bearing potential&#xD;
             must be willing to ensure that they or their partner use effective contraception&#xD;
             during the trial and for 3 months thereafter&#xD;
&#xD;
          -  A propensity to tolerate confined spaces for prolonged periods&#xD;
&#xD;
          -  Suitability for radial and/or brachial artery blood sampling and cannulation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of clinically significant cardio-or cerebrovascular, pulmonary, renal,&#xD;
             hepatic, neurological, mental or gastrointestinal disorder or any other major disorder&#xD;
             that may interfere with the objectives of the study, as judged by the investigator&#xD;
&#xD;
          -  The subject has 1 or more clinical laboratory test values outside the reference range,&#xD;
             which in the opinion of the investigator are clinically significant&#xD;
&#xD;
          -  Screening supine blood pressure &gt;=140 mm Hg (systolic) or &gt;=90 mm Hg (diastolic),&#xD;
             following at least 5 minutes of supine rest. If blood pressure (BP) is &gt;=140 mm Hg&#xD;
             (systolic) or &gt;=90 mm Hg (diastolic), the BP should be repeated two more times and the&#xD;
             average of the three BP values should be used to determine the subject's eligibility&#xD;
&#xD;
          -  The subject has a resting pulse &lt;=50 or &gt;=100 bpm at the Screening Visit&#xD;
&#xD;
          -  The subject has a QTc interval &gt;430 ms (Bazett's or Fridericia's correction) at the&#xD;
             Screening Visit or at he Baseline Visit, as calculated by the ECG equipment and&#xD;
             evaluated by the investigator. The ECG may be repeated if any of the values are&#xD;
             out-of-range or abnormal&#xD;
&#xD;
          -  The subject is pregnant or breastfeeding&#xD;
&#xD;
          -  Habitual use of nicotine products and addictive substances&#xD;
&#xD;
          -  Any finding of significance on MRI scans as judged by the investigator.&#xD;
&#xD;
          -  Any previous PET measurements for scientific purposes&#xD;
&#xD;
          -  Use of CNS active drugs and/or NSAIDs 1 month prior to the first PET examination&#xD;
&#xD;
          -  The subject is exposed to significant level of ionizing radiation at work&#xD;
&#xD;
          -  The subject has undergone any clinical procedures involving significant exposure to&#xD;
             radiation (excluding dental X-ray and common X-rays of the chest or extremities)&#xD;
&#xD;
          -  The subject has received radio labeled material less than 12&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 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>Karolinska Institute, Dept. of Clinical Neuroscience</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>February 4, 2020</last_update_submitted>
  <last_update_submitted_qc>February 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</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>Parkinson Disease</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/NCT03826134
org study id: 18039A
nct id: NCT03826134
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the usefulness of a PET radioligand to estimate the binding on the mGlu4
      receptor in the brain. mGlu4 has been proposed as a therapeutic target in Parkinson's
      disease.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Total distribution volumes (VT) for each region of interest (ROI)
time frame: Up to 3 days
measure: Binding potential (BPND) in the ROI's
time frame: Up to 3 days
arm group label: [11C]-PXT012253
arm group type: Experimental
intervention type: Drug
intervention name: [11C]PXT012253
description: Single intravenous bolus injection. The injected amount will be less than 5 μg. The radioactive dose is approximately 400 MBq per 70 kg body weight.
arm group label: [11C]-PXT012253
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Email contact via H.Lundbeck A/S
role: Study Director
affiliation: LundbeckClinicalTrials@Lundbeck.com
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Parkinson Disease