<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/NCT01660815</url>
  </required_header>
  <id_info>
    <org_study_id>18F-AV-45-J02</org_study_id>
    <secondary_id>I6E-AV-AVBA</secondary_id>
    <nct_id>NCT01660815</nct_id>
  </id_info>
  <brief_title>A Study of Florbetapir (18F) in Japanese Healthy Volunteers</brief_title>
  <official_title>PET Whole Body Biodistribution Using Florbetapir (18F)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Avid Radiopharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Avid Radiopharmaceuticals</source>
  <brief_summary>
    <textblock>
      This study will determine how florbetapir (18F) (18F-AV-45) radioactivity is distributed&#xD;
      throughout the body of Japanese subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Whole Body Radiation Dosimetry</measure>
    <time_frame>0-360 minutes</time_frame>
    <description>Radiation dose values (millisieverts/megabecquerel [mSv/MBq]) were calculated for target organs, including the adrenals, brain, breasts, gall bladder wall, heart wall, kidneys, lower large intestine wall, liver, lungs, muscle, ovaries, osteogenic cells, pancreas, red marrow, skin, small intestine, spleen, stomach wall, testes, thymus, thyroid, total body, upper large intestine wall, urinary bladder wall, and uterus.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitively normal, healthy volunteers at least 45 years of age.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>florbetapir (18F)</intervention_name>
    <description>IV injection, 370 MBq (10mCi), single dose</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <other_name>18F-AV-45</other_name>
    <other_name>Amyvid</other_name>
    <other_name>Florbetapir F 18</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Are Japanese cognitively normal healthy males or females at least 45 years of age;&#xD;
&#xD;
          2. Give informed consent; and&#xD;
&#xD;
          3. Are able to lie still on the imaging table for periods up to one hour.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have had radiation exposure (PET, SPECT or CT scans) for experimental purposes within&#xD;
             the last year;&#xD;
&#xD;
          2. Are claustrophobic or otherwise unable to tolerate the imaging procedure;&#xD;
&#xD;
          3. Have medical conditions or surgical history that would confound evaluation of&#xD;
             dosimetry (e.g., liver disease, colectomy etc.);&#xD;
&#xD;
          4. Have current clinically significant cardiovascular disease. Clinically significant&#xD;
             cardiovascular disease usually includes one or more of the following:&#xD;
&#xD;
               1. cardiac surgery or myocardial infarction within the last 6 months;&#xD;
&#xD;
               2. unstable angina;&#xD;
&#xD;
               3. coronary artery disease that required a change in medication within the last 3&#xD;
                  months;&#xD;
&#xD;
               4. decompensated congestive heart failure;&#xD;
&#xD;
               5. significant cardiac arrhythmia or conduction disturbance, particularly those&#xD;
                  resulting in atrial or ventricular fibrillation, or causing syncope, near&#xD;
                  syncope, or other alterations in mental status;&#xD;
&#xD;
               6. severe mitral or aortic valvular disease;&#xD;
&#xD;
               7. uncontrolled high blood pressure;&#xD;
&#xD;
               8. congenital heart disease;&#xD;
&#xD;
               9. clinically significant abnormal result on ECG, including but not limited to&#xD;
                  QTc&gt;450 msec; Before enrolling a patient with any evidence of the above&#xD;
                  conditions, the investigator must contact the sponsor;&#xD;
&#xD;
          5. Have current clinically significant medical comorbidities, as indicated by history,&#xD;
             physical exam, or laboratory evaluations that might pose a potential safety risk,&#xD;
             interfere with the absorption or metabolism of the study medication or limit&#xD;
             interpretation of the trial results. These include but are not limited to clinically&#xD;
             significant hepatic, renal, pulmonary, metabolic or endocrine disease, cancer;&#xD;
&#xD;
          6. Have a history of drug or alcohol abuse within the last year, or prior prolonged&#xD;
             history of abuse;&#xD;
&#xD;
          7. Have a history of epilepsy or convulsions, except for febrile convulsions during&#xD;
             childhood;&#xD;
&#xD;
          8. Have clinically significant infectious disease, including AIDS or HIV infection or&#xD;
             previous positive test for hepatitis B, hepatitis C, HIV-1, or HIV-2;&#xD;
&#xD;
          9. Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to&#xD;
             the study imaging session;&#xD;
&#xD;
         10. Are females of childbearing potential who are not surgically sterile, not refraining&#xD;
             from sexual activity or not using reliable methods of contraception. Females of&#xD;
             childbearing potential must not be pregnant (negative serum β-HCG at the time of&#xD;
             screening) or breastfeeding at screening. Females must agree to avoid becoming&#xD;
             pregnant, and must agree to refrain from sexual activity or to use reliable methods of&#xD;
             contraception such as prescribed birth control or IUD for 24 hours following&#xD;
             administration of florbetapir (18F);&#xD;
&#xD;
         11. Have a history of severe drug allergy or hypersensitivity;&#xD;
&#xD;
         12. Received an investigational medication within the last 30 days or who have&#xD;
             participated in a clinical trial with any experimental medication in the last 30 days.&#xD;
&#xD;
             Additionally, the time between the last dose of the previous experimental medication&#xD;
             and enrollment (completion of screening assessments) must be at least equal to 5 times&#xD;
             the terminal half-life of the previous experimental medication;&#xD;
&#xD;
         13. Have known hypersensitivity to alcohol; and&#xD;
&#xD;
         14. In the opinion of the investigator, are otherwise unsuitable for a study of this type.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chief Medical Officer</last_name>
    <role>Study Director</role>
    <affiliation>Avid Radiopharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kobe</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <results_first_submitted>July 16, 2013</results_first_submitted>
  <results_first_submitted_qc>July 16, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 19, 2013</results_first_posted>
  <last_update_submitted>July 16, 2013</last_update_submitted>
  <last_update_submitted_qc>July 16, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2013</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>Alzheimer Disease</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Healthy Volunteers</title>
          <description>Cognitively normal, healthy volunteers at least 45 years of age.&#xD;
florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </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>Healthy Volunteers</title>
          <description>Cognitively normal, healthy volunteers at least 45 years of age.&#xD;
florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="7"/>
          </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="54.4" spread="5.71"/>
                  </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="1"/>
                  </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>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Whole Body Radiation Dosimetry</title>
        <description>Radiation dose values (millisieverts/megabecquerel [mSv/MBq]) were calculated for target organs, including the adrenals, brain, breasts, gall bladder wall, heart wall, kidneys, lower large intestine wall, liver, lungs, muscle, ovaries, osteogenic cells, pancreas, red marrow, skin, small intestine, spleen, stomach wall, testes, thymus, thyroid, total body, upper large intestine wall, urinary bladder wall, and uterus.</description>
        <time_frame>0-360 minutes</time_frame>
        <population>Analysis population includes the 6 subjects who completed the study and had valid imaging data for quantitative analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>50-kg Model</title>
            <description>Radiation dose estimate using a 50-kg model.</description>
          </group>
          <group group_id="O2">
            <title>70-kg Model</title>
            <description>Radiation dose estimate using a 70-kg model.</description>
          </group>
        </group_list>
        <measure>
          <title>Whole Body Radiation Dosimetry</title>
          <description>Radiation dose values (millisieverts/megabecquerel [mSv/MBq]) were calculated for target organs, including the adrenals, brain, breasts, gall bladder wall, heart wall, kidneys, lower large intestine wall, liver, lungs, muscle, ovaries, osteogenic cells, pancreas, red marrow, skin, small intestine, spleen, stomach wall, testes, thymus, thyroid, total body, upper large intestine wall, urinary bladder wall, and uterus.</description>
          <population>Analysis population includes the 6 subjects who completed the study and had valid imaging data for quantitative analysis.</population>
          <units>mSv/MBq</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 group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adrenals</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0186" spread="0.000990"/>
                    <measurement group_id="O2" value="0.0132" spread="0.000685"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Brain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0179" spread="0.00234"/>
                    <measurement group_id="O2" value="0.0157" spread="0.00207"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breasts</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0108" spread="0.00123"/>
                    <measurement group_id="O2" value="0.00759" spread="0.000843"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gallbladder wall</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.310" spread="0.192"/>
                    <measurement group_id="O2" value="0.268" spread="0.167"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heart wall</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0247" spread="0.00453"/>
                    <measurement group_id="O2" value="0.0171" spread="0.00316"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kidneys</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0237" spread="0.00393"/>
                    <measurement group_id="O2" value="0.0177" spread="0.00291"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lower large intestine wall</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0210" spread="0.00245"/>
                    <measurement group_id="O2" value="0.0161" spread="0.00178"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Liver</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0456" spread="0.0249"/>
                    <measurement group_id="O2" value="0.0313" spread="0.0169"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lungs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0127" spread="0.000885"/>
                    <measurement group_id="O2" value="0.00844" spread="0.000516"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Muscle</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0136" spread="0.000989"/>
                    <measurement group_id="O2" value="0.00987" spread="0.000723"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Osteogenic cells</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0493" spread="0.00575"/>
                    <measurement group_id="O2" value="0.0327" spread="0.00377"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ovaries</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0194" spread="0.000880"/>
                    <measurement group_id="O2" value="0.0139" spread="0.000727"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pancreas</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0205" spread="0.00188"/>
                    <measurement group_id="O2" value="0.0150" spread="0.00151"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Red marrow</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0221" spread="0.00182"/>
                    <measurement group_id="O2" value="0.0155" spread="0.00118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00993" spread="0.00113"/>
                    <measurement group_id="O2" value="0.00730" spread="0.000823"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Small intestine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0364" spread="0.00668"/>
                    <measurement group_id="O2" value="0.0269" spread="0.00506"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spleen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0151" spread="0.00134"/>
                    <measurement group_id="O2" value="0.0105" spread="0.00105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stomach wall</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0165" spread="0.000991"/>
                    <measurement group_id="O2" value="0.0120" spread="0.000689"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Testes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0128" spread="0.00118"/>
                    <measurement group_id="O2" value="0.00913" spread="0.000910"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thymus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0133" spread="0.00176"/>
                    <measurement group_id="O2" value="0.00931" spread="0.00125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thyroid</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0130" spread="0.00203"/>
                    <measurement group_id="O2" value="0.00922" spread="0.00143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total body</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0161" spread="0.000468"/>
                    <measurement group_id="O2" value="0.0117" spread="0.000320"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Upper large intestine wall</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0397" spread="0.00805"/>
                    <measurement group_id="O2" value="0.0299" spread="0.00611"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urinary bladder wall</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0578" spread="0.0364"/>
                    <measurement group_id="O2" value="0.0442" spread="0.0276"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Uterus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0199" spread="0.00157"/>
                    <measurement group_id="O2" value="0.0146" spread="0.00123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Effective dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0207" spread="0.00266"/>
                    <measurement group_id="O2" value="0.0149" spread="0.00198"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Healthy Volunteers</title>
          <description>Cognitively normal, healthy volunteers at least 45 years of age.&#xD;
florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose</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="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 15.0</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="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </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>Chief Medical Officer</name_or_title>
      <organization>Avid Radiopharmaceuticals, Inc.</organization>
      <phone>215-298-0700</phone>
      <email>clinicaloperations@avidrp.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/NCT01660815
org study id: 18F-AV-45-J02
secondary id: I6E-AV-AVBA
nct id: NCT01660815
lead sponsor: 
collaborator: 
This study will determine how florbetapir (18F) (18F-AV-45) radioactivity is distributed
      throughout the body of Japanese subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Whole Body Radiation Dosimetry
time frame: 0-360 minutes
description: Radiation dose values (millisieverts/megabecquerel [mSv/MBq]) were calculated for target organs, including the adrenals, brain, breasts, gall bladder wall, heart wall, kidneys, lower large intestine wall, liver, lungs, muscle, ovaries, osteogenic cells, pancreas, red marrow, skin, small intestine, spleen, stomach wall, testes, thymus, thyroid, total body, upper large intestine wall, urinary bladder wall, and uterus.
arm group label: Healthy Volunteers
arm group type: Experimental
description: Cognitively normal, healthy volunteers at least 45 years of age.
intervention type: Drug
intervention name: florbetapir (18F)
description: IV injection, 370 MBq (10mCi), single dose
arm group label: Healthy Volunteers
other name: 18F-AV-45
other name: Amyvid
other name: Florbetapir F 18
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Chief Medical Officer
role: Study Director
affiliation: Avid Radiopharmaceuticals
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Alzheimer Disease
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 