<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/NCT03019289</url>
  </required_header>
  <id_info>
    <org_study_id>TV7820-IMG-10082</org_study_id>
    <secondary_id>2016-001757-41</secondary_id>
    <nct_id>NCT03019289</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Sigma-1 and Dopamine-2 Receptor Occupancy by Pridopidine in the Human Brain of Healthy Volunteers and in Patients With Huntington's Disease</brief_title>
  <official_title>A Phase I, Open-Label, Single-Dose, Adaptive (S)-(-)-[18F]Fluspidine and [18F]Fallypride Positron Emission Tomography Study to Evaluate Sigma-1 and Dopamine-2 Receptor Occupancy by Pridopidine in the Human Brain of Healthy Volunteers and in Patients With Huntington's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prilenia</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Prilenia</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>
      The purpose of this study is to demonstrate engagement of pridopidine with S1R and D2R&#xD;
      (optional) in the living human brain. No formal statistical analysis will be conducted&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 19, 2017</start_date>
  <completion_date type="Actual">February 9, 2018</completion_date>
  <primary_completion_date type="Actual">February 9, 2018</primary_completion_date>
  <phase>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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sigma-1 Receptor Occupancy</measure>
    <time_frame>2 hours after oral administration of pridopidine</time_frame>
    <description>Receptor occupancy of pridopidine to Sigma-1 receptors (S1R) in the brain was assessed from Positron Emission Tomography (PET) imaging with (S)-(-)-[18F]fluspidine</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Plasma Concentration of Pridopidine</measure>
    <time_frame>PK sampling 1 h before pridopidine dosing, and 5, 15, 30, 45, 60 min, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 h after dosing.</time_frame>
    <description>Maximum plasma concentration of pridopidine based on noncompartmental analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum (Peak) Concentration (Tmax)</measure>
    <time_frame>PK sampling 1 h before pridopidine dosing, and 5, 15, 30, 45, 60 min, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 h after dosing.</time_frame>
    <description>Multiple PK samples over 24 hours will be calculated for pridopidine and its metabolite TV-45065 in plasma using non-compartmental methods, when possible.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Dopamine-2 Receptor Occupancy</measure>
    <time_frame>2 h after pridopidine dosing</time_frame>
    <description>RO of D2 (Dopamine-2) at 2 hours after oral administration of pridopidine (90 mg dose level) was investigated in 4 healthy volunteers using [18F]fallypride</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Health Volunteers, Huntington Disease</condition>
  <arm_group>
    <arm_group_label>pridopidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pridopidine (TV-7820) capsules</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>pridopidine (90 mg)</intervention_name>
    <description>single dose will be administered in Cohort 1. Other optional cohorts 2 and 3 may include single dose 0.5 mg, 1 mg, 2.5 mg, 5 mg, 10 mg, 22.5 mg, 45 mg, or 90 mg. The dose will be selected based on the results obtained from Cohorts 1 and 2.</description>
    <arm_group_label>pridopidine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  In general, good physical health as determined by medical history and psychiatric&#xD;
             history, suicidality assessment &amp; physical examination&#xD;
&#xD;
          -  Men who are potentially fertile (not surgically [eg, vasectomy] or congenitally&#xD;
             sterile&#xD;
&#xD;
          -  Patients with Huntington's disease (HD): diagnosis of HD and with an onset of HD after&#xD;
             18 years of age&#xD;
&#xD;
               -  Additional criteria apply, please contact the investigator for more information&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject has been previously exposed to ionizing radiation or radioactive&#xD;
             substances as a result of clinical research or medical treatment in the past 10 years.&#xD;
&#xD;
          -  The subject has a counterindication to having an MRI&#xD;
&#xD;
          -  History of alcohol, narcotic, or any other substance dependence in the past 2 years&#xD;
&#xD;
          -  Additional Exclusion criteria to patients with Huntington's disease:&#xD;
&#xD;
          -  The patient has a severe motor impairment that might cause artifacts.&#xD;
&#xD;
          -  Patients with a known history of Long QT Syndrome or a first degree relative with this&#xD;
             condition.&#xD;
&#xD;
          -  Treatment with any investigational product within 6 weeks of screening or patients&#xD;
             planning to participate in another clinical study assessing any investigational&#xD;
             product during the study.&#xD;
&#xD;
               -  Additional criteria apply, please contact the investigator for more information&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Teva Medical Expert, MD</last_name>
    <role>Study Director</role>
    <affiliation>Teva Pharmaceuticals USA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Teva Investigational Site 32648</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Grachev ID, Meyer PM, Becker GA, Bronzel M, Marsteller D, Pastino G, Voges O, Rabinovich L, Knebel H, Zientek F, Rullmann M, Sattler B, Patt M, Gerhards T, Strauss M, Kluge A, Brust P, Savola JM, Gordon MF, Geva M, Hesse S, Barthel H, Hayden MR, Sabri O. Sigma-1 and dopamine D2/D3 receptor occupancy of pridopidine in healthy volunteers and patients with Huntington disease: a [18F] fluspidine and [18F] fallypride PET study. Eur J Nucl Med Mol Imaging. 2021 Apr;48(4):1103-1115. doi: 10.1007/s00259-020-05030-3. Epub 2020 Sep 29.</citation>
    <PMID>32995944</PMID>
  </reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <results_first_submitted>October 18, 2021</results_first_submitted>
  <results_first_submitted_qc>October 18, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">November 16, 2021</results_first_posted>
  <last_update_submitted>November 18, 2021</last_update_submitted>
  <last_update_submitted_qc>November 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2021</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>Huntington Disease</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 2, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT03019289/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT03019289/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Healthy volunteers (HV) and patients with Huntington Disease (HD) were enrolled. The first participant was enrolled on 22 March 2017; the last subject completed the study on 09 February 2018.</recruitment_details>
      <pre_assignment_details>The screening period had a duration of up to 8 weeks. A total of 49 healthy subjects and 3 HD patients were screened; of these, 20 healthy subjects and 3 HD patients met the eligibility criteria and were enrolled in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>A: Cohort 1: P90 + (S)-(-)-FPD; HV</title>
          <description>Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
        </group>
        <group group_id="P2">
          <title>A: Cohort 2: P45 + (S)-(-)-FPD; HV</title>
          <description>Healthy volunteers (HV) receiving a single dose of 45 mg pridopidine (P45) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
        </group>
        <group group_id="P3">
          <title>A: Cohort 2: P22.5 + (S)-(-)-FPD; HV</title>
          <description>Healthy volunteers (HV) receiving a single dose of 22.5 mg pridopidine (P22.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
        </group>
        <group group_id="P4">
          <title>A: Cohort 3: P5 + (S)-(-)-FPD; HV</title>
          <description>Healthy volunteers (HV) receiving a single dose of 5 mg pridopidine (P5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
        </group>
        <group group_id="P5">
          <title>A: Cohort 7: P1 + (S)-(-)-FPD; HV</title>
          <description>Healthy volunteers (HV) receiving a single dose of 1 mg pridopidine (P1) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
        </group>
        <group group_id="P6">
          <title>A: Cohort 7: P0.5 + (S)-(-)-FPD; HV</title>
          <description>Healthy volunteers (HV) receiving a single dose of 0.5 mg pridopidine (P0.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
        </group>
        <group group_id="P7">
          <title>A: Cohort 6; P90 + (S)-(-)-FPD; HD</title>
          <description>Patients with Huntington's Disease (HD) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
        </group>
        <group group_id="P8">
          <title>B: Cohort 4: P90 + Fallypride; HV</title>
          <description>Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer [18F]fallypride for neuroimaging in Part B of the study</description>
        </group>
        <group group_id="P9">
          <title>Cohort 0: (S)-(-)-FPD, HV</title>
          <description>Healthy volunteers (HV) receiving a single dose of radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="3"/>
                <participants group_id="P8" count="4"/>
                <participants group_id="P9" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="3"/>
                <participants group_id="P8" count="4"/>
                <participants group_id="P9" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All subjects/patients enrolled</population>
      <group_list>
        <group group_id="B1">
          <title>A: Cohort 1: P90 + (S)-(-)-FPD; HV</title>
          <description>Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
        </group>
        <group group_id="B2">
          <title>A: Cohort 2: P45 + (S)-(-)-FPD; HV</title>
          <description>Healthy volunteers (HV) receiving a single dose of 45 mg pridopidine (P45) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
        </group>
        <group group_id="B3">
          <title>A: Cohort 2: P22.5 + (S)-(-)-FPD; HV</title>
          <description>Healthy volunteers (HV) receiving a single dose of 22.5 mg pridopidine (P22.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
        </group>
        <group group_id="B4">
          <title>A: Cohort 3: P5 + (S)-(-)-FPD; HV</title>
          <description>Healthy volunteers (HV) receiving a single dose of 5 mg pridopidine (P5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
        </group>
        <group group_id="B5">
          <title>A: Cohort 7: P1 + (S)-(-)-FPD; HV</title>
          <description>Healthy volunteers (HV) receiving a single dose of 1 mg pridopidine (P1) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
        </group>
        <group group_id="B6">
          <title>A: Cohort 7: P0.5 + (S)-(-)-FPD; HV</title>
          <description>Healthy volunteers (HV) receiving a single dose of 0.5 mg pridopidine (P0.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
        </group>
        <group group_id="B7">
          <title>A: Cohort 6; P90 + (S)-(-)-FPD; HD</title>
          <description>Patients with Huntington's Disease (HD) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
        </group>
        <group group_id="B8">
          <title>B: Cohort 4: P90 + Fallypride; HV</title>
          <description>Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer [18F]fallypride for neuroimaging in Part B of the study</description>
        </group>
        <group group_id="B9">
          <title>Cohort 0: (S)-(-)-FPD, HV</title>
          <description>Healthy volunteers (HV) receiving a single dose of radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging</description>
        </group>
        <group group_id="B10">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
            <count group_id="B2" value="1"/>
            <count group_id="B3" value="3"/>
            <count group_id="B4" value="2"/>
            <count group_id="B5" value="1"/>
            <count group_id="B6" value="1"/>
            <count group_id="B7" value="3"/>
            <count group_id="B8" value="4"/>
            <count group_id="B9" value="3"/>
            <count group_id="B10" value="23"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.0" lower_limit="27" upper_limit="30"/>
                    <measurement group_id="B2" value="26.0" lower_limit="26" upper_limit="26"/>
                    <measurement group_id="B3" value="25.0" lower_limit="25" upper_limit="28"/>
                    <measurement group_id="B4" value="27.5" lower_limit="27" upper_limit="28"/>
                    <measurement group_id="B5" value="30" lower_limit="30" upper_limit="30"/>
                    <measurement group_id="B6" value="25.0" lower_limit="25" upper_limit="25"/>
                    <measurement group_id="B7" value="40.0" lower_limit="32" upper_limit="58"/>
                    <measurement group_id="B8" value="28.0" lower_limit="25" upper_limit="35"/>
                    <measurement group_id="B9" value="29.0" lower_limit="25" upper_limit="30"/>
                    <measurement group_id="B10" value="28" lower_limit="25" upper_limit="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="4"/>
                    <measurement group_id="B9" value="3"/>
                    <measurement group_id="B10" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="4"/>
                    <measurement group_id="B9" value="2"/>
                    <measurement group_id="B10" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black/African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="4"/>
                    <measurement group_id="B9" value="3"/>
                    <measurement group_id="B10" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Sigma-1 Receptor Occupancy</title>
        <description>Receptor occupancy of pridopidine to Sigma-1 receptors (S1R) in the brain was assessed from Positron Emission Tomography (PET) imaging with (S)-(-)-[18F]fluspidine</description>
        <time_frame>2 hours after oral administration of pridopidine</time_frame>
        <population>Patients enrolled and receiving pridopidine. Patients from Cohort B (receiving fallypride only) and Cohort 0 (no pridopidine treatment) were not included in the analysis</population>
        <group_list>
          <group group_id="O1">
            <title>A: Cohort 1: P90 + (S)-(-)-FPD; HV</title>
            <description>Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
          </group>
          <group group_id="O2">
            <title>A: Cohort 2: P45 + (S)-(-)-FPD; HV</title>
            <description>Healthy volunteers (HV) receiving a single dose of 45 mg pridopidine (P45) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
          </group>
          <group group_id="O3">
            <title>A: Cohort 2: P22.5 + (S)-(-)-FPD; HV</title>
            <description>Healthy volunteers (HV) receiving a single dose of 22.5 mg pridopidine (P22.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
          </group>
          <group group_id="O4">
            <title>A: Cohort 3: P5 + (S)-(-)-FPD; HV</title>
            <description>Healthy volunteers (HV) receiving a single dose of 5 mg pridopidine (P5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
          </group>
          <group group_id="O5">
            <title>A: Cohort 7: P1 + (S)-(-)-FPD; HV</title>
            <description>Healthy volunteers (HV) receiving a single dose of 1 mg pridopidine (P1) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
          </group>
          <group group_id="O6">
            <title>A: Cohort 7: P0.5 + (S)-(-)-FPD; HV</title>
            <description>Healthy volunteers (HV) receiving a single dose of 0.5 mg pridopidine (P0.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
          </group>
          <group group_id="O7">
            <title>A: Cohort 6; P90 + (S)-(-)-FPD; HD</title>
            <description>Patients with Huntington's Disease (HD) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Sigma-1 Receptor Occupancy</title>
          <description>Receptor occupancy of pridopidine to Sigma-1 receptors (S1R) in the brain was assessed from Positron Emission Tomography (PET) imaging with (S)-(-)-[18F]fluspidine</description>
          <population>Patients enrolled and receiving pridopidine. Patients from Cohort B (receiving fallypride only) and Cohort 0 (no pridopidine treatment) were not included in the analysis</population>
          <units>percentage of receptor occupancy</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="1"/>
                <count group_id="O7" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.21" lower_limit="88.82" upper_limit="95.67"/>
                    <measurement group_id="O2" value="87.19" lower_limit="87.19" upper_limit="87.19"/>
                    <measurement group_id="O3" value="86.67" lower_limit="84.06" upper_limit="89.24"/>
                    <measurement group_id="O4" value="77.96" lower_limit="76.75" upper_limit="79.16"/>
                    <measurement group_id="O5" value="41.77" lower_limit="41.77" upper_limit="41.77"/>
                    <measurement group_id="O6" value="17.55" lower_limit="17.55" upper_limit="17.55"/>
                    <measurement group_id="O7" value="87.37" lower_limit="80.36" upper_limit="93.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Plasma Concentration of Pridopidine</title>
        <description>Maximum plasma concentration of pridopidine based on noncompartmental analysis</description>
        <time_frame>PK sampling 1 h before pridopidine dosing, and 5, 15, 30, 45, 60 min, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 h after dosing.</time_frame>
        <population>Patients enrolled who received pridopidine and had sufficient data to calculate at least 1 evaluable pharmacokinetic parameter for pridopidine.</population>
        <group_list>
          <group group_id="O1">
            <title>A: Cohort 1: P90 + (S)-(-)-FPD; HV</title>
            <description>Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
          </group>
          <group group_id="O2">
            <title>A: Cohort 2: P45 + (S)-(-)-FPD; HV</title>
            <description>Healthy volunteers (HV) receiving a single dose of 45 mg pridopidine (P45) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
          </group>
          <group group_id="O3">
            <title>A: Cohort 2: P22.5 + (S)-(-)-FPD; HV</title>
            <description>Healthy volunteers (HV) receiving a single dose of 22.5 mg pridopidine (P22.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
          </group>
          <group group_id="O4">
            <title>A: Cohort 3: P5 + (S)-(-)-FPD; HV</title>
            <description>Healthy volunteers (HV) receiving a single dose of 5 mg pridopidine (P5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
          </group>
          <group group_id="O5">
            <title>A: Cohort 7: P1 + (S)-(-)-FPD; HV</title>
            <description>Healthy volunteers (HV) receiving a single dose of 1 mg pridopidine (P1) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
          </group>
          <group group_id="O6">
            <title>A: Cohort 7: P0.5 + (S)-(-)-FPD; HV</title>
            <description>Healthy volunteers (HV) receiving a single dose of 0.5 mg pridopidine (P0.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
          </group>
          <group group_id="O7">
            <title>A: Cohort 6; P90 + (S)-(-)-FPD; HD</title>
            <description>Patients with Huntington's Disease (HD) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
          </group>
          <group group_id="O8">
            <title>B: Cohort 4: P90 + FPD; HV</title>
            <description>Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer [18F]fallypride for neuroimaging in Part B of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Plasma Concentration of Pridopidine</title>
          <description>Maximum plasma concentration of pridopidine based on noncompartmental analysis</description>
          <population>Patients enrolled who received pridopidine and had sufficient data to calculate at least 1 evaluable pharmacokinetic parameter for pridopidine.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="1"/>
                <count group_id="O7" value="3"/>
                <count group_id="O8" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="552" lower_limit="496" upper_limit="614"/>
                    <measurement group_id="O2" value="307" lower_limit="307" upper_limit="307"/>
                    <measurement group_id="O3" value="147" lower_limit="117" upper_limit="184"/>
                    <measurement group_id="O4" value="25.9" lower_limit="16.1" upper_limit="41.8"/>
                    <measurement group_id="O5" value="2.90" lower_limit="2.90" upper_limit="2.90"/>
                    <measurement group_id="O6" value="1.33" lower_limit="1.33" upper_limit="1.33"/>
                    <measurement group_id="O7" value="764" lower_limit="666" upper_limit="877"/>
                    <measurement group_id="O8" value="452" lower_limit="244" upper_limit="724"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Reach Maximum (Peak) Concentration (Tmax)</title>
        <description>Multiple PK samples over 24 hours will be calculated for pridopidine and its metabolite TV-45065 in plasma using non-compartmental methods, when possible.</description>
        <time_frame>PK sampling 1 h before pridopidine dosing, and 5, 15, 30, 45, 60 min, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 h after dosing.</time_frame>
        <population>Patients enrolled who received pridopidine and had sufficient data to calculate at least 1 evaluable pharmacokinetic parameter for pridopidine</population>
        <group_list>
          <group group_id="O1">
            <title>A: Cohort 1: P90 + (S)-(-)-FPD; HV</title>
            <description>Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
          </group>
          <group group_id="O2">
            <title>A: Cohort 2: P45 + (S)-(-)-FPD; HV</title>
            <description>Healthy volunteers (HV) receiving a single dose of 45 mg pridopidine (P45) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
          </group>
          <group group_id="O3">
            <title>A: Cohort 2: P22.5 + (S)-(-)-FPD; HV</title>
            <description>Healthy volunteers (HV) receiving a single dose of 22.5 mg pridopidine (P22.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
          </group>
          <group group_id="O4">
            <title>A: Cohort 3: P5 + (S)-(-)-FPD; HV</title>
            <description>Healthy volunteers (HV) receiving a single dose of 5 mg pridopidine (P5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
          </group>
          <group group_id="O5">
            <title>A: Cohort 7: P1 + (S)-(-)-FPD; HV</title>
            <description>Healthy volunteers (HV) receiving a single dose of 1 mg pridopidine (P1) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
          </group>
          <group group_id="O6">
            <title>A: Cohort 7: P0.5 + (S)-(-)-FPD; HV</title>
            <description>Healthy volunteers (HV) receiving a single dose of 0.5 mg pridopidine (P0.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
          </group>
          <group group_id="O7">
            <title>A: Cohort 6; P90 + (S)-(-)-FPD; HD</title>
            <description>Patients with Huntington's Disease (HD) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
          </group>
          <group group_id="O8">
            <title>B: Cohort 4: P90 + Fallypride; HV</title>
            <description>Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer [18F]fallypride for neuroimaging in Part B of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Reach Maximum (Peak) Concentration (Tmax)</title>
          <description>Multiple PK samples over 24 hours will be calculated for pridopidine and its metabolite TV-45065 in plasma using non-compartmental methods, when possible.</description>
          <population>Patients enrolled who received pridopidine and had sufficient data to calculate at least 1 evaluable pharmacokinetic parameter for pridopidine</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="1"/>
                <count group_id="O7" value="3"/>
                <count group_id="O8" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.97" lower_limit="1.50" upper_limit="3.00"/>
                    <measurement group_id="O2" value="1.98" lower_limit="1.98" upper_limit="1.98"/>
                    <measurement group_id="O3" value="1.00" lower_limit="0.75" upper_limit="1.50"/>
                    <measurement group_id="O4" value="1.00" lower_limit="0.75" upper_limit="1.50"/>
                    <measurement group_id="O5" value="1.98" lower_limit="1.98" upper_limit="1.98"/>
                    <measurement group_id="O6" value="1.97" lower_limit="1.97" upper_limit="1.97"/>
                    <measurement group_id="O7" value="1.00" lower_limit="0.50" upper_limit="1.62"/>
                    <measurement group_id="O8" value="2.26" lower_limit="1.00" upper_limit="5.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Dopamine-2 Receptor Occupancy</title>
        <description>RO of D2 (Dopamine-2) at 2 hours after oral administration of pridopidine (90 mg dose level) was investigated in 4 healthy volunteers using [18F]fallypride</description>
        <time_frame>2 h after pridopidine dosing</time_frame>
        <population>Patients enrolled and treated</population>
        <group_list>
          <group group_id="O1">
            <title>B: Cohort 4: P90 + FPD; HV</title>
            <description>Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer [18F]fallypride for neuroimaging in Part B of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Dopamine-2 Receptor Occupancy</title>
          <description>RO of D2 (Dopamine-2) at 2 hours after oral administration of pridopidine (90 mg dose level) was investigated in 4 healthy volunteers using [18F]fallypride</description>
          <population>Patients enrolled and treated</population>
          <units>percent volume/volume</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.34" spread="2.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From signing of the informed consent through to 7 days after the last administration of study drug.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>A: Cohort 1: P90 + (S)-(-)-FPD; HV</title>
          <description>Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
        </group>
        <group group_id="E2">
          <title>A: Cohort 2: P45 + (S)-(-)-FPD; HV</title>
          <description>Healthy volunteers (HV) receiving a single dose of 45 mg pridopidine (P45) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
        </group>
        <group group_id="E3">
          <title>A: Cohort 2: P22.5 + (S)-(-)-FPD; HV</title>
          <description>Healthy volunteers (HV) receiving a single dose of 22.5 mg pridopidine (P22.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
        </group>
        <group group_id="E4">
          <title>A: Cohort 3: P5 + (S)-(-)-FPD; HV</title>
          <description>Healthy volunteers (HV) receiving a single dose of 5 mg pridopidine (P5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
        </group>
        <group group_id="E5">
          <title>A: Cohort 7: P1 + (S)-(-)-FPD; HV</title>
          <description>Healthy volunteers (HV) receiving a single dose of 1 mg pridopidine (P1) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
        </group>
        <group group_id="E6">
          <title>A: Cohort 7: P0.5 + (S)-(-)-FPD; HV</title>
          <description>Healthy volunteers (HV) receiving a single dose of 0.5 mg pridopidine (P0.5) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
        </group>
        <group group_id="E7">
          <title>A: Cohort 6; P90 + (S)-(-)-FPD; HD</title>
          <description>Patients with Huntington's Disease (HD) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging in Part A of the study</description>
        </group>
        <group group_id="E8">
          <title>B: Cohort 4: P90 + Fallypride; HV</title>
          <description>Healthy volunteers (HV) receiving a single dose of 90 mg pridopidine (P90) and radiolabeled PET tracer [18F]fallypride for neuroimaging in Part B of the study</description>
        </group>
        <group group_id="E9">
          <title>Cohort 0: (S)-(-)-FPD, HV</title>
          <description>Healthy volunteers (HV) receiving a single dose of radiolabeled PET tracer (S)-(-)-[18F]fluspidine ((S)-(-)-FPD) for neuroimaging</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (19.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Catheter site hematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="3" subjects_affected="3" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Catheter site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Catheter site paraesthisia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Vessel puncture site haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Sports injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Haematocrit decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Red blood cell count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Data and results are owned by the sponsor. Results can be used by the institution for internal noncommercial research, education and patient care, and as required under applicable laws and regulations. Other uses require prior written consent of the sponsor.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Prilenia</name_or_title>
      <organization>Prilenia</organization>
      <phone>+972 775558 ext 482</phone>
      <email>info@prilenia.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03019289
org study id: TV7820-IMG-10082
secondary id: 2016-001757-41
nct id: NCT03019289
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to demonstrate engagement of pridopidine with S1R and D2R
      (optional) in the living human brain. No formal statistical analysis will be conducted
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Sigma-1 Receptor Occupancy
time frame: 2 hours after oral administration of pridopidine
description: Receptor occupancy of pridopidine to Sigma-1 receptors (S1R) in the brain was assessed from Positron Emission Tomography (PET) imaging with (S)-(-)-[18F]fluspidine
measure: Maximum Plasma Concentration of Pridopidine
time frame: PK sampling 1 h before pridopidine dosing, and 5, 15, 30, 45, 60 min, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 h after dosing.
description: Maximum plasma concentration of pridopidine based on noncompartmental analysis
measure: Time to Reach Maximum (Peak) Concentration (Tmax)
time frame: PK sampling 1 h before pridopidine dosing, and 5, 15, 30, 45, 60 min, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, and 24 h after dosing.
description: Multiple PK samples over 24 hours will be calculated for pridopidine and its metabolite TV-45065 in plasma using non-compartmental methods, when possible.
measure: Dopamine-2 Receptor Occupancy
time frame: 2 h after pridopidine dosing
description: RO of D2 (Dopamine-2) at 2 hours after oral administration of pridopidine (90 mg dose level) was investigated in 4 healthy volunteers using [18F]fallypride
arm group label: pridopidine
arm group type: Experimental
description: Pridopidine (TV-7820) capsules
intervention type: Drug
intervention name: pridopidine (90 mg)
description: single dose will be administered in Cohort 1. Other optional cohorts 2 and 3 may include single dose 0.5 mg, 1 mg, 2.5 mg, 5 mg, 10 mg, 22.5 mg, 45 mg, or 90 mg. The dose will be selected based on the results obtained from Cohorts 1 and 2.
arm group label: pridopidine
criteria: 
gender: Male
minimum age: 25 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Teva Medical Expert, MD
role: Study Director
affiliation: Teva Pharmaceuticals USA
facility: 
country: Germany
citation: Grachev ID, Meyer PM, Becker GA, Bronzel M, Marsteller D, Pastino G, Voges O, Rabinovich L, Knebel H, Zientek F, Rullmann M, Sattler B, Patt M, Gerhards T, Strauss M, Kluge A, Brust P, Savola JM, Gordon MF, Geva M, Hesse S, Barthel H, Hayden MR, Sabri O. Sigma-1 and dopamine D2/D3 receptor occupancy of pridopidine in healthy volunteers and patients with Huntington disease: a [18F] fluspidine and [18F] fallypride PET study. Eur J Nucl Med Mol Imaging. 2021 Apr;48(4):1103-1115. doi: 10.1007/s00259-020-05030-3. Epub 2020 Sep 29.
PMID: 32995944
responsible party type: Sponsor
mesh term: Huntington Disease
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 