<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/NCT02249728</url>
  </required_header>
  <id_info>
    <org_study_id>PBT2-102</org_study_id>
    <secondary_id>2014-000389-24</secondary_id>
    <nct_id>NCT02249728</nct_id>
  </id_info>
  <brief_title>Absorption, Metabolism and Excretion Study of [14C]PBT2 and Absolute Bioavailability of PBT2</brief_title>
  <official_title>A Phase I , Open-Label Study to Evaluate the Absorption, Metabolism and Excretion of [14C]-PBT2 and to Estimate the Absolute Bioavailability of PBT2 in Healthy Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prana Biotechnology Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pranabio</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to investigate how the test drug, PBT2, is taken up, broken down&#xD;
      and removed from the body when given as an oral capsule, a radiolabelled oral suspension and&#xD;
      a radiolabelled intravenous injection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</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>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absolute Bioavailability of PBT2 (F%)</measure>
    <time_frame>0 to 72 hours post oral dose</time_frame>
    <description>Absolute bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to an IV dose, computed as AUC(oral)/AUC(IV), with range from 0% (no drug) to 100% (all of the administered drug).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mass Balance</measure>
    <time_frame>168 h (7 days) post dose</time_frame>
    <description>Amount excreted as a percentage of the administered dose (%Ae)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>IV PK Profile of [14C]-PBT2 and Total Radioactivity as Assessed by AUC(0 Last)</measure>
    <time_frame>0 to 72 h post oral dose</time_frame>
    <description>Area under the plasma concentration vs time curve from time 0h to the last time point of IV [14C]-PBT2 .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oral PK Profile of PBT2 as Assessed by AUC(0-last)</measure>
    <time_frame>72 h post oral dose</time_frame>
    <description>Area under the plasma concentration vs time curve from time 0h to the last time point of oral PBT2 .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and Tolerability of PBT2</measure>
    <time_frame>72 h post oral dose</time_frame>
    <description>As assessed by the number of participants with adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio of Whole Blood, Plasma [14C] PBT2 at 24 Hours</measure>
    <time_frame>0 to 24 hours</time_frame>
    <description>Ratio of whole blood, plasma [14C] PBT2 at 24 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oral PK Profile of [14C]-PBT2 as Assessed by AUC(0-last)</measure>
    <time_frame>0 to 72 hours</time_frame>
    <description>area under the plasma concentration vs time curve to the last timepoint</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Absolute Bioavailability</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IV PBT2 microtracer and oral PBT2 single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Radiolabelled AME</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>oral 14C PBT2</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IV PBT2 microtracer and oral PBT2 single dose</intervention_name>
    <arm_group_label>Absolute Bioavailability</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oral 14C-PBT2</intervention_name>
    <arm_group_label>Radiolabelled AME</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males&#xD;
&#xD;
          -  Body mass index of 18.0 to 35.0 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of any drug or alcohol abuse in the past 2 years&#xD;
&#xD;
          -  Regular alcohol consumption &gt;21 units per week (1 unit = ½ pint beer, 25 mL of 40%&#xD;
             spirit or a 125 mL glass of wine)&#xD;
&#xD;
          -  Current smokers and those who have smoked within the last 12 months&#xD;
&#xD;
          -  Radiation exposure, including that from the present study, excluding background&#xD;
             radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv&#xD;
             in the last 12 months or 10 mSv in the last 5 years.&#xD;
&#xD;
          -  Clinically significant abnormal biochemistry, haematology or urinalysis as judged by&#xD;
             the investigator&#xD;
&#xD;
          -  Positive drugs of abuse test result&#xD;
&#xD;
          -  Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or&#xD;
             human immunodeficiency virus (HIV) results&#xD;
&#xD;
          -  History of cardiovascular, renal, hepatic, chronic respiratory or GI disease as judged&#xD;
             by the investigator&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Caroline Herd, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Prana Biotechnology Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Quotient Clinical</name>
      <address>
        <city>Nottingham</city>
        <state>Nottinghamshire</state>
        <zip>NG11 6JS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <results_first_submitted>November 17, 2015</results_first_submitted>
  <results_first_submitted_qc>February 28, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 30, 2016</results_first_posted>
  <last_update_submitted>February 28, 2016</last_update_submitted>
  <last_update_submitted_qc>February 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were screened and enrolled into one study site in the United Kingdom.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>All Study Participants</title>
          <description>In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.&#xD;
In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Part One (4 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Part Two (up to 6 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Study Participants</title>
          <description>In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Following completion of Part One, participants crossed over into Part Two (Radiolabelled AME), where a single dose of oral PBT2 250 mg 14C suspension was administered.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.8" spread="5.9"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.55" spread="4.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Absolute Bioavailability of PBT2 (F%)</title>
        <description>Absolute bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to an IV dose, computed as AUC(oral)/AUC(IV), with range from 0% (no drug) to 100% (all of the administered drug).</description>
        <time_frame>0 to 72 hours post oral dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part One Absolute Bioavailability</title>
            <description>In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.&#xD;
In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Bioavailability of PBT2 (F%)</title>
          <description>Absolute bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to an IV dose, computed as AUC(oral)/AUC(IV), with range from 0% (no drug) to 100% (all of the administered drug).</description>
          <population>PK Population</population>
          <units>percentage of absolute bioavailability</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.936" spread="28.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mass Balance</title>
        <description>Amount excreted as a percentage of the administered dose (%Ae)</description>
        <time_frame>168 h (7 days) post dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part Two Radiolabelled AME</title>
            <description>In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.&#xD;
In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered</description>
          </group>
        </group_list>
        <measure>
          <title>Mass Balance</title>
          <description>Amount excreted as a percentage of the administered dose (%Ae)</description>
          <population>PK Population</population>
          <units>percentage of administered dose</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.65" spread="1.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>IV PK Profile of [14C]-PBT2 and Total Radioactivity as Assessed by AUC(0 Last)</title>
        <description>Area under the plasma concentration vs time curve from time 0h to the last time point of IV [14C]-PBT2 .</description>
        <time_frame>0 to 72 h post oral dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part Two Radiolabelled AME</title>
            <description>In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.&#xD;
In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered</description>
          </group>
        </group_list>
        <measure>
          <title>IV PK Profile of [14C]-PBT2 and Total Radioactivity as Assessed by AUC(0 Last)</title>
          <description>Area under the plasma concentration vs time curve from time 0h to the last time point of IV [14C]-PBT2 .</description>
          <population>PK Population</population>
          <units>ng*hr/ml</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.40" spread="28.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Oral PK Profile of PBT2 as Assessed by AUC(0-last)</title>
        <description>Area under the plasma concentration vs time curve from time 0h to the last time point of oral PBT2 .</description>
        <time_frame>72 h post oral dose</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Part One Absolute Bioavailability</title>
            <description>In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.&#xD;
In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered</description>
          </group>
        </group_list>
        <measure>
          <title>Oral PK Profile of PBT2 as Assessed by AUC(0-last)</title>
          <description>Area under the plasma concentration vs time curve from time 0h to the last time point of oral PBT2 .</description>
          <units>ng*hr/ml</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1330" spread="51.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety and Tolerability of PBT2</title>
        <description>As assessed by the number of participants with adverse events</description>
        <time_frame>72 h post oral dose</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>All Study Participants</title>
            <description>In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Following completion of Part One, participants crossed over into Part Two (Radiolabelled AME), where a single dose of oral PBT2 250 mg 14C suspension was administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety and Tolerability of PBT2</title>
          <description>As assessed by the number of participants with adverse events</description>
          <population>Safety Population</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ratio of Whole Blood, Plasma [14C] PBT2 at 24 Hours</title>
        <description>Ratio of whole blood, plasma [14C] PBT2 at 24 hours</description>
        <time_frame>0 to 24 hours</time_frame>
        <population>PK population</population>
        <group_list>
          <group group_id="O1">
            <title>Part Two Radiolabelled AME</title>
            <description>In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.&#xD;
In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered</description>
          </group>
        </group_list>
        <measure>
          <title>Ratio of Whole Blood, Plasma [14C] PBT2 at 24 Hours</title>
          <description>Ratio of whole blood, plasma [14C] PBT2 at 24 hours</description>
          <population>PK population</population>
          <units>ratio [14C] PBT2</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.488" spread="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Oral PK Profile of [14C]-PBT2 as Assessed by AUC(0-last)</title>
        <description>area under the plasma concentration vs time curve to the last timepoint</description>
        <time_frame>0 to 72 hours</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part Two Radiolabelle AME</title>
            <description>In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.&#xD;
In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered</description>
          </group>
        </group_list>
        <measure>
          <title>Oral PK Profile of [14C]-PBT2 as Assessed by AUC(0-last)</title>
          <description>area under the plasma concentration vs time curve to the last timepoint</description>
          <population>PK Population</population>
          <units>ng*hr/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1660" spread="48.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Reported AEs from dosing in Part 1 to the end of the study (Day 15 to 20).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>All Study Participants</title>
          <description>In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.&#xD;
In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 17.0</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="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Mild Hyperhidrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Dianne Angus</name_or_title>
      <organization>Prana Biotechnology</organization>
      <phone>+61 393494906</phone>
      <email>info@pranabio.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/NCT02249728
org study id: PBT2-102
secondary id: 2014-000389-24
nct id: NCT02249728
lead sponsor: 
has dmc: No
The purpose of the study is to investigate how the test drug, PBT2, is taken up, broken down
      and removed from the body when given as an oral capsule, a radiolabelled oral suspension and
      a radiolabelled intravenous injection.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Absolute Bioavailability of PBT2 (F%)
time frame: 0 to 72 hours post oral dose
description: Absolute bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to an IV dose, computed as AUC(oral)/AUC(IV), with range from 0% (no drug) to 100% (all of the administered drug).
measure: Mass Balance
time frame: 168 h (7 days) post dose
description: Amount excreted as a percentage of the administered dose (%Ae)
measure: IV PK Profile of [14C]-PBT2 and Total Radioactivity as Assessed by AUC(0 Last)
time frame: 0 to 72 h post oral dose
description: Area under the plasma concentration vs time curve from time 0h to the last time point of IV [14C]-PBT2 .
measure: Oral PK Profile of PBT2 as Assessed by AUC(0-last)
time frame: 72 h post oral dose
description: Area under the plasma concentration vs time curve from time 0h to the last time point of oral PBT2 .
measure: Safety and Tolerability of PBT2
time frame: 72 h post oral dose
description: As assessed by the number of participants with adverse events
measure: Ratio of Whole Blood, Plasma [14C] PBT2 at 24 Hours
time frame: 0 to 24 hours
description: Ratio of whole blood, plasma [14C] PBT2 at 24 hours
measure: Oral PK Profile of [14C]-PBT2 as Assessed by AUC(0-last)
time frame: 0 to 72 hours
description: area under the plasma concentration vs time curve to the last timepoint
arm group label: Absolute Bioavailability
arm group type: Experimental
description: IV PBT2 microtracer and oral PBT2 single dose
arm group label: Radiolabelled AME
arm group type: Experimental
description: oral 14C PBT2
intervention type: Drug
intervention name: IV PBT2 microtracer and oral PBT2 single dose
arm group label: Absolute Bioavailability
intervention type: Drug
intervention name: oral 14C-PBT2
arm group label: Radiolabelled AME
criteria: 
gender: Male
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Caroline Herd, PhD
role: Study Director
affiliation: Prana Biotechnology Ltd
facility: 
country: United Kingdom
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 