<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/NCT03270579</url>
  </required_header>
  <id_info>
    <org_study_id>CR108379</org_study_id>
    <secondary_id>2017-002262-47</secondary_id>
    <secondary_id>64140284EDI1002</secondary_id>
    <nct_id>NCT03270579</nct_id>
  </id_info>
  <brief_title>A Study to Investigate the Regional Brain Kinetics of the Positron Emission Tomography Ligand [18F]JNJ-64511070</brief_title>
  <official_title>An Open-Label Study to Investigate the Regional Brain Kinetics of the Positron Emission Tomography Ligand [18F]JNJ-64511070</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of the study is to measure the whole-body distribution and radiation&#xD;
      dosimetry of [18F]JNJ-64511070 in healthy male participants by positron emission tomography&#xD;
      (PET) (Part A); and to measure the uptake, binding, distribution, and washout of&#xD;
      [18F]JNJ-64511070 in the brain of healthy male participants by PET and to model tissue&#xD;
      specific kinetics of [18F]JNJ-64511070 with the appropriate arterial input function (IF)&#xD;
      (Part B).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 12, 2017</start_date>
  <completion_date type="Actual">February 6, 2018</completion_date>
  <primary_completion_date type="Actual">February 6, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Part A: Effective Radiation Dose Following Injection of [18F]JNJ-64511070</measure>
    <time_frame>Up to 5 hours on Day 1</time_frame>
    <description>The tissue radioactivity will be measured per organ for up to 5 hours after injection of up to 185 megaBecquerel (MBq) of [18F]JNJ-64511070 and corrected for attenuation by computed tomography (CT) transmission scans using positron emission tomography (PET) /CT. These measurements will be used to estimate effective radiation dose per organ and total body.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part B: Total and Regional Brain Compartmental Kinetics for Volume of Distribution of [18F]JNJ-64511070 in Brain</measure>
    <time_frame>Day 1</time_frame>
    <description>The Distribution of [18F]JNJ-64511070 in brain will be measured by PET/CT scans obtained from the time of injection for up to 120 minutes along with measurement of the tracer input function with arterial samples for intact tracer and metabolites to establish the total and regional compartmental kinetics and volume of distribution (V[t]) of [18F]JNJ-64511070.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>Approximately Up to 4 weeks</time_frame>
    <description>An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Part A: [18F]JNJ-64511070</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive an intravenous (IV) bolus injection of [18F]JNJ-64511070 at a dose of 185 megaBecquerel (MBq) on Day 1 of Part A to investigate the total body biodistribution and measure the radiation dosimetry of [18F]JNJ-64511070.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: [18F]JNJ-64511070</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive an IV bolus injection of [18F]JNJ-64511070 at a dose of 185 MBq on Day 1 of Part B to measure the uptake, binding, distribution, and washout of [18F]JNJ-64511070 and to model the tissue specific kinetics of [18F]JNJ-64511070 in the human brain with the appropriate arterial IF.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[18F]JNJ-64511070</intervention_name>
    <description>An IV injection of 185 MBq [18F]JNJ-64511070 will be administered.</description>
    <arm_group_label>Part A: [18F]JNJ-64511070</arm_group_label>
    <arm_group_label>Part B: [18F]JNJ-64511070</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) inclusive&#xD;
&#xD;
          -  Nonsmoker (not smoked for 3 months prior to screening)&#xD;
&#xD;
          -  Is willing to allow the investigators to place an arterial catheter in the radial&#xD;
             artery and is assessed via physical examination (Allen test) to be a good candidate&#xD;
             for arterial catheter placement (Part B only)&#xD;
&#xD;
          -  During the study and for a minimum of 1 spermatogenesis cycle (defined as&#xD;
             approximately 90 days) after receiving the last dose of study drug, a man: a) who is&#xD;
             sexually active with a woman of childbearing potential and has not had vasectomy must&#xD;
             agree to use a condom and their female partner should also use a highly effective&#xD;
             method of birth control for at least the same duration; b) who is sexually active with&#xD;
             a woman who is pregnant must use a condom; c) must agree not to donate sperm&#xD;
&#xD;
          -  Participants must have signed an informed consent document indicating that they&#xD;
             understand the purpose of, and procedures required for,the study and are willing to&#xD;
             participate in the study and comply with the study procedures and restrictions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exposed to greater than (&gt;) 1 milliSievert (mSv) of ionizing radiation participating&#xD;
             as a participant in research studies in the 12 months before the start of enrolment in&#xD;
             this study&#xD;
&#xD;
          -  Clinically significant abnormal values for hematology, clinical chemistry or&#xD;
             urinalysis at screening or admission. It is expected that laboratory values will&#xD;
             generally be within the normal range for the laboratory, though minor deviations,&#xD;
             which are not considered to be of clinical significance to both the investigator are&#xD;
             acceptable&#xD;
&#xD;
          -  Clinically significant abnormal physical and neurological examination, vital signs or&#xD;
             12-lead electrocardiogram (ECG) at screening or admission&#xD;
&#xD;
          -  History of or current significant medical illness including (but not limited to)&#xD;
             cardiac arrhythmias or other cardiac disease, coagulation abnormalities, or other&#xD;
             conditions that the Investigator considers should exclude the participant and preclude&#xD;
             their ability to participate in study procedures. Participants with a history&#xD;
             significant liver or renal disease, or difficulty in urination, which could affect the&#xD;
             metabolism and elimination of the radiotracer or radiometabolites should be excluded.&#xD;
             Participants with a history of epilepsy or fits or unexplained black-outs or loss of&#xD;
             consciousness should also be excluded&#xD;
&#xD;
          -  Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C (HCV)&#xD;
             antibodies or human immunodeficiency (HIV) antibodies unless the participant has been&#xD;
             successfully treated for HCV or HIV. In such cases, the response should be confirmed&#xD;
             with RNA testing for the relevant pathogen&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Research &amp; Development, LLC. Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ Leuven Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>April 18, 2019</last_update_submitted>
  <last_update_submitted_qc>April 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03270579
org study id: CR108379
secondary id: 2017-002262-47
secondary id: 64140284EDI1002
nct id: NCT03270579
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main purpose of the study is to measure the whole-body distribution and radiation
      dosimetry of [18F]JNJ-64511070 in healthy male participants by positron emission tomography
      (PET) (Part A); and to measure the uptake, binding, distribution, and washout of
      [18F]JNJ-64511070 in the brain of healthy male participants by PET and to model tissue
      specific kinetics of [18F]JNJ-64511070 with the appropriate arterial input function (IF)
      (Part B).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Part A: Effective Radiation Dose Following Injection of [18F]JNJ-64511070
time frame: Up to 5 hours on Day 1
description: The tissue radioactivity will be measured per organ for up to 5 hours after injection of up to 185 megaBecquerel (MBq) of [18F]JNJ-64511070 and corrected for attenuation by computed tomography (CT) transmission scans using positron emission tomography (PET) /CT. These measurements will be used to estimate effective radiation dose per organ and total body.
measure: Part B: Total and Regional Brain Compartmental Kinetics for Volume of Distribution of [18F]JNJ-64511070 in Brain
time frame: Day 1
description: The Distribution of [18F]JNJ-64511070 in brain will be measured by PET/CT scans obtained from the time of injection for up to 120 minutes along with measurement of the tracer input function with arterial samples for intact tracer and metabolites to establish the total and regional compartmental kinetics and volume of distribution (V[t]) of [18F]JNJ-64511070.
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
time frame: Approximately Up to 4 weeks
description: An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
arm group label: Part A: [18F]JNJ-64511070
arm group type: Experimental
description: Participants will receive an intravenous (IV) bolus injection of [18F]JNJ-64511070 at a dose of 185 megaBecquerel (MBq) on Day 1 of Part A to investigate the total body biodistribution and measure the radiation dosimetry of [18F]JNJ-64511070.
arm group label: Part B: [18F]JNJ-64511070
arm group type: Experimental
description: Participants will receive an IV bolus injection of [18F]JNJ-64511070 at a dose of 185 MBq on Day 1 of Part B to measure the uptake, binding, distribution, and washout of [18F]JNJ-64511070 and to model the tissue specific kinetics of [18F]JNJ-64511070 in the human brain with the appropriate arterial IF.
intervention type: Drug
intervention name: [18F]JNJ-64511070
description: An IV injection of 185 MBq [18F]JNJ-64511070 will be administered.
arm group label: Part A: [18F]JNJ-64511070
arm group label: Part B: [18F]JNJ-64511070
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janssen Research & Development, LLC. Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
facility: 
country: Belgium
responsible party type: Sponsor