<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/NCT01732237</url>
  </required_header>
  <id_info>
    <org_study_id>CR100878</org_study_id>
    <secondary_id>42396302EDI1003</secondary_id>
    <nct_id>NCT01732237</nct_id>
  </id_info>
  <brief_title>A Study to Investigate the Pharmacokinetics of JNJ-42396302, JNJ-53773187 and JNJ-42692507 in Healthy Male Participants</brief_title>
  <official_title>A Single Dose Study to Investigate the Pharmacokinetics of an Oral Microdose of JNJ-42396302, JNJ-53773187 and JNJ-42692507 in Healthy Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen-Cilag International NV</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen-Cilag International NV</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to investigate the pharmacokinetics (what the body does to the&#xD;
      medication) of JNJ-42396302, JNJ-53773187 and JNJ-42692507 after administration of a single&#xD;
      oral dose of 100 micrograms under fasted conditions in healthy male participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase I, open-label (all people know the identity of the intervention) and&#xD;
      parallel-group (each group of patients will be treated at the same time), randomized (the&#xD;
      study medication is assigned by chance) study in healthy male participants, to investigate&#xD;
      the pharmacokinetics of a single oral dose of 100 micrograms of JNJ-42396302, JNJ-53773187 or&#xD;
      JNJ-42692507. The study consists of 3 phases, ie, screening phase (21 days prior to first&#xD;
      dose of study medication), a treatment phase, and a follow up phase. In the treatment phase,&#xD;
      participants will be divided into 3 treatment groups with 6 participants each, to receive a&#xD;
      single dose of 100 micrograms of JNJ-42396302, JNJ-53773187 or JNJ-42692507 following an&#xD;
      overnight fast of at least 10 hours. Safety evaluations for adverse events, clinical&#xD;
      laboratory tests, physical examination, vital signs and electrocardiogram will be monitored&#xD;
      throughout the study. The total duration of the study will be approximately 4 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum observed plasma analyte concentration (Cmax) of JNJ-42396302</measure>
    <time_frame>10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration time curve for JNJ-42396302</measure>
    <time_frame>10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Actual sampling time to reach the maximum plasma analyte concentration (tmax) of JNJ-42396302</measure>
    <time_frame>10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent terminal elimination half-life of JNJ-42396302</measure>
    <time_frame>10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum observed plasma analyte concentration (Cmax) of JNJ-53773187</measure>
    <time_frame>10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration time curve for JNJ-53773187</measure>
    <time_frame>10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Actual sampling time to reach the maximum plasma analyte concentration (tmax) of JNJ-53773187</measure>
    <time_frame>10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent terminal elimination half-life of JNJ-53773187</measure>
    <time_frame>10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum observed plasma analyte concentration (Cmax) of JNJ-42692507</measure>
    <time_frame>10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration time curve for JNJ-42692507</measure>
    <time_frame>10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Actual sampling time to reach the maximum plasma analyte concentration (tmax) of JNJ-42692507</measure>
    <time_frame>10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent terminal elimination half-life of JNJ-42692507</measure>
    <time_frame>10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>within 7 days after the last dose of the study medication</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>JNJ-42396302</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive JNJ-42396302 100 micrograms as a single oral dose after an overnight fast of at least 10 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JNJ-42692507</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive JNJ-42692507 100 micrograms as a single oral dose after an overnight fast of at least 10 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JNJ-53773187</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive JNJ-53773187 100 micrograms as a single oral dose after an overnight fast of at least 10 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-42396302</intervention_name>
    <description>A single dose of JNJ-42396302 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.</description>
    <arm_group_label>JNJ-42396302</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-42692507</intervention_name>
    <description>A single dose of JNJ-42692507 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.</description>
    <arm_group_label>JNJ-42692507</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-53773187</intervention_name>
    <description>A single dose of JNJ-53773187 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.</description>
    <arm_group_label>JNJ-53773187</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant should be healthy male on the basis of physical examination, medical&#xD;
             history, vital signs, electrocardiogram, the results of blood biochemistry and&#xD;
             hematology tests and a urinalysis&#xD;
&#xD;
          -  Participant must have a Body Mass Index of 18.5 to 30.0 kg/m2&#xD;
&#xD;
          -  Have a blood pressure between 90 and 140 mm Hg systolic, inclusive, and no higher than&#xD;
             90 mm Hg diastolic&#xD;
&#xD;
          -  Agrees to protocol-defined use of effective contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A positive human immunodeficiency virus-type 1 or type 2 test and Hepatitis A, B or C&#xD;
             infection at screening or admission&#xD;
&#xD;
          -  Participant with abnormal physical, vital or laboratory values&#xD;
&#xD;
          -  Currently active cardiovascular, bronchospastic respiratory disease, dyspnea, diabetes&#xD;
             mellitus, movement disorder and infectious disease&#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-Cilag International NV Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen-Cilag International NV</affiliation>
  </overall_official>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>September 9, 2013</last_update_submitted>
  <last_update_submitted_qc>September 9, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy</keyword>
  <keyword>JNJ-42396302</keyword>
  <keyword>JNJ-42692507</keyword>
  <keyword>JNJ-53773187</keyword>
  <keyword>Pharmacokinetics</keyword>
  <!-- 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/NCT01732237
org study id: CR100878
secondary id: 42396302EDI1003
nct id: NCT01732237
lead sponsor: 
has dmc: No
The purpose of the study is to investigate the pharmacokinetics (what the body does to the
      medication) of JNJ-42396302, JNJ-53773187 and JNJ-42692507 after administration of a single
      oral dose of 100 micrograms under fasted conditions in healthy male participants.
This is a phase I, open-label (all people know the identity of the intervention) and
      parallel-group (each group of patients will be treated at the same time), randomized (the
      study medication is assigned by chance) study in healthy male participants, to investigate
      the pharmacokinetics of a single oral dose of 100 micrograms of JNJ-42396302, JNJ-53773187 or
      JNJ-42692507. The study consists of 3 phases, ie, screening phase (21 days prior to first
      dose of study medication), a treatment phase, and a follow up phase. In the treatment phase,
      participants will be divided into 3 treatment groups with 6 participants each, to receive a
      single dose of 100 micrograms of JNJ-42396302, JNJ-53773187 or JNJ-42692507 following an
      overnight fast of at least 10 hours. Safety evaluations for adverse events, clinical
      laboratory tests, physical examination, vital signs and electrocardiogram will be monitored
      throughout the study. The total duration of the study will be approximately 4 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum observed plasma analyte concentration (Cmax) of JNJ-42396302
time frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
measure: Area under the plasma concentration time curve for JNJ-42396302
time frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
measure: Actual sampling time to reach the maximum plasma analyte concentration (tmax) of JNJ-42396302
time frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
measure: Apparent terminal elimination half-life of JNJ-42396302
time frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
measure: Maximum observed plasma analyte concentration (Cmax) of JNJ-53773187
time frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
measure: Area under the plasma concentration time curve for JNJ-53773187
time frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
measure: Actual sampling time to reach the maximum plasma analyte concentration (tmax) of JNJ-53773187
time frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
measure: Apparent terminal elimination half-life of JNJ-53773187
time frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
measure: Maximum observed plasma analyte concentration (Cmax) of JNJ-42692507
time frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
measure: Area under the plasma concentration time curve for JNJ-42692507
time frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
measure: Actual sampling time to reach the maximum plasma analyte concentration (tmax) of JNJ-42692507
time frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
measure: Apparent terminal elimination half-life of JNJ-42692507
time frame: 10, 20, 30, and 45 minutes; 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours
measure: Number of patients with adverse events
time frame: within 7 days after the last dose of the study medication
arm group label: JNJ-42396302
arm group type: Experimental
description: Patients will receive JNJ-42396302 100 micrograms as a single oral dose after an overnight fast of at least 10 hours.
arm group label: JNJ-42692507
arm group type: Experimental
description: Patients will receive JNJ-42692507 100 micrograms as a single oral dose after an overnight fast of at least 10 hours.
arm group label: JNJ-53773187
arm group type: Experimental
description: Patients will receive JNJ-53773187 100 micrograms as a single oral dose after an overnight fast of at least 10 hours.
intervention type: Drug
intervention name: JNJ-42396302
description: A single dose of JNJ-42396302 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.
arm group label: JNJ-42396302
intervention type: Drug
intervention name: JNJ-42692507
description: A single dose of JNJ-42692507 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.
arm group label: JNJ-42692507
intervention type: Drug
intervention name: JNJ-53773187
description: A single dose of JNJ-53773187 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.
arm group label: JNJ-53773187
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janssen-Cilag International NV Clinical Trial
role: Study Director
affiliation: Janssen-Cilag International NV
responsible party type: Sponsor