<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/NCT02218073</url>
  </required_header>
  <id_info>
    <org_study_id>CR104998</org_study_id>
    <secondary_id>42756493EDI1002</secondary_id>
    <secondary_id>2014-002634-31</secondary_id>
    <nct_id>NCT02218073</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic Study of JNJ-42756493 in Healthy Participants</brief_title>
  <official_title>A Single-Dose, Open-Label, Randomized, Two-Way Crossover Pharmacokinetic Study to Assess the Relative Bioavailability of Orally Administered JNJ-42756493 Following Intake of a Tablet Versus a Solution and to Assess the Absolute Bioavailability of Orally Administered JNJ-42756493 Following Concomitant Administration of an Intravenous Microdose of the Stable Isotope JNJ-61818549 in Healthy Subjects</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the absolute bioavailability (the extent to which a&#xD;
      drug or other substance becomes available to the body) of JNJ-42756493 following a single 10&#xD;
      milligram (mg) dose as an oral solution administered in combination with a single intravenous&#xD;
      administration of a microdose (100 microgram [mcg]) of JNJ-61818549 and to evaluate the&#xD;
      relative bioavailability of 10 mg JNJ-42756493 following an oral solution (reference) and a&#xD;
      tablet (test) formulation in a crossover (method used to switch subjects from one study group&#xD;
      to another in a clinical trial) design in healthy participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized (study drug assigned by chance), open-label (all people know the&#xD;
      identity of the intervention), 2-way crossover, single-dose, and single-center, Phase 1 study&#xD;
      of oral JNJ-42756493 in healthy participants. The duration of the study is approximately&#xD;
      36-63 days: 2-20 days Screening, two 7 days open-label treatment periods, 12-14 days washout&#xD;
      and 12-14-day follow-up (Day 13-15 of period 2). All participants will be randomly assigned&#xD;
      to 1 of 2 treatment sequences. In Treatment Sequence AB: JNJ-42756493 10 mg tablet&#xD;
      formulation will be administered on Day 1 of Period 1 and 100 mcg JNJ-61818549 will be&#xD;
      administered intravenously 2 hours after the intake of 10 mg JNJ-42756493 oral solution on&#xD;
      Day 1 of Period 2. In Treatment Sequence BA: 100 mcg JNJ-61818549 will be administered&#xD;
      intravenously after the intake of 10 mg JNJ-42756493 oral solution on Day 1 of Period 1 and&#xD;
      10 mg JNJ-42756493 tablet formulation will be administered on Day 1 of Period 2. A minimum 12&#xD;
      days washout is required between treatment periods. Participants will primarily be analyzed&#xD;
      for pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues&#xD;
      over time). Participants' safety will be monitored throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Relative Bioavailability: Maximum Plasma Concentration (Cmax)</measure>
    <time_frame>Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose</time_frame>
    <description>The Cmax is the maximum observed plasma concentration of JNJ-42756493.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute Bioavailability</measure>
    <time_frame>Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose</time_frame>
    <description>Absolute bioavailability will be measured by Area under concentration time-curve (AUC [0-24]), AUC (0-last) and AUC (0-infinity).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Relative Bioavailability: Area under concententration time-curve (AUC)</measure>
    <time_frame>Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose</time_frame>
    <description>Relative bioavailability will be measured by AUC (0-24), AUC (0-last) and AUC (0-infinity).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Concentration (tmax)</measure>
    <time_frame>Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose</time_frame>
    <description>The tmax is time to reach the maximum observed plasma concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elimination Half-Life (t1/2)</measure>
    <time_frame>Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose</time_frame>
    <description>Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Treatment Sequence AB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 10 milligram (mg) JNJ-42756493 tablet orally on Day 1 of Period 1 and 100 microgram (mcg) of JNJ-61818549 as intravenous injection 2 hours after the intake of 10 mg JNJ-42756493 oral solution on Day 1 of Period 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Sequence BA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 100 mcg of JNJ-61818549 as intravenous injection after the intake of 10 mg JNJ-42756493 oral solution on Day 1 of Period 1 and JNJ-42756493 10 mg tablet orally on Day 1 of Period 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-42756493 10 mg tablet</intervention_name>
    <description>Participants will be administered with 10 milligram (mg) JNJ-42756493 tablet orally either on Day 1 of Period 1 or on Day 1 of Period 2.</description>
    <arm_group_label>Treatment Sequence AB</arm_group_label>
    <arm_group_label>Treatment Sequence BA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-42756493 10 mg Oral Solution</intervention_name>
    <description>Participants will be administered with 10 mg JNJ-42756493 oral solution either on Day 1 of Period 1 or on Day 1 of Period 2.</description>
    <arm_group_label>Treatment Sequence AB</arm_group_label>
    <arm_group_label>Treatment Sequence BA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-61818549</intervention_name>
    <description>Participants will receive 100 mcg of JNJ-61818549 as intravenous injection on Day 1 of Period 2 or Day 1 of Period 1.</description>
    <arm_group_label>Treatment Sequence AB</arm_group_label>
    <arm_group_label>Treatment Sequence BA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Received a thorough explanation of the optional pharmacogenomic research component of&#xD;
             the study and was offered an opportunity to participate by signing the separate&#xD;
             pharmacogenomic informed consent document&#xD;
&#xD;
          -  If a woman, must be postmenopausal (no spontaneous menses for at least 2 years), or&#xD;
             surgically sterile&#xD;
&#xD;
          -  If a woman, must have a negative serum beta-human chorionic gonadotropin (hCG)&#xD;
             pregnancy test at screening&#xD;
&#xD;
          -  Body mass index (BMI) (weight kilogram [kg]/ height square meter[m^2] between 18 and&#xD;
             30 kg/m^2 (inclusive), and body weight not less than 50 kg&#xD;
&#xD;
          -  Non-smoker for at least 6 months before entering the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of or current clinically significant medical illness including (but not&#xD;
             limited to) cardiac arrhythmias or other cardiac disease, hematologic disease,&#xD;
             coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid&#xD;
             abnormalities, significant pulmonary disease, including bronchospastic respiratory&#xD;
             disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease,&#xD;
             neurologic or psychiatric disease, metabolic bone disease (other than osteoporosis),&#xD;
             infection, or any other illness that the investigator considers should exclude the&#xD;
             subject or that could interfere with the interpretation of the study results&#xD;
&#xD;
          -  Clinically significant abnormal values for hematology, clinical chemistry or&#xD;
             urinalysis at screening and predose on Day -2 (urinalysis only) and on Day -1 of both&#xD;
             treatment Period as deemed appropriate by the investigator. Retesting of abnormal lab&#xD;
             values that may lead to exclusion will be allowed once&#xD;
&#xD;
          -  Clinically significant abnormal physical examination, vital signs or 12-lead&#xD;
             electrocardiogram (ECG) at screening and Day -1 of both treatment Periods as deemed&#xD;
             appropriate by the investigator&#xD;
&#xD;
          -  Use of any prescription or nonprescription medication (including vitamins and herbal&#xD;
             supplements), except for paracetamol and hormonal replacement therapy within 14 days&#xD;
             before the first dose of the study drug is scheduled&#xD;
&#xD;
          -  History of, or a reason to believe a participant has a history of drug or alcohol&#xD;
             abuse within the past 5 years&#xD;
      </textblock>
    </criteria>
    <gender>All</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>
      <address>
        <city>Merksem</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>January 7, 2015</last_update_submitted>
  <last_update_submitted_qc>January 7, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy</keyword>
  <keyword>JNJ-42756493</keyword>
  <keyword>JNJ-61818549</keyword>
  <keyword>Isotope</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/NCT02218073
org study id: CR104998
secondary id: 42756493EDI1002
secondary id: 2014-002634-31
nct id: NCT02218073
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the absolute bioavailability (the extent to which a
      drug or other substance becomes available to the body) of JNJ-42756493 following a single 10
      milligram (mg) dose as an oral solution administered in combination with a single intravenous
      administration of a microdose (100 microgram [mcg]) of JNJ-61818549 and to evaluate the
      relative bioavailability of 10 mg JNJ-42756493 following an oral solution (reference) and a
      tablet (test) formulation in a crossover (method used to switch subjects from one study group
      to another in a clinical trial) design in healthy participants.
This is a randomized (study drug assigned by chance), open-label (all people know the
      identity of the intervention), 2-way crossover, single-dose, and single-center, Phase 1 study
      of oral JNJ-42756493 in healthy participants. The duration of the study is approximately
      36-63 days: 2-20 days Screening, two 7 days open-label treatment periods, 12-14 days washout
      and 12-14-day follow-up (Day 13-15 of period 2). All participants will be randomly assigned
      to 1 of 2 treatment sequences. In Treatment Sequence AB: JNJ-42756493 10 mg tablet
      formulation will be administered on Day 1 of Period 1 and 100 mcg JNJ-61818549 will be
      administered intravenously 2 hours after the intake of 10 mg JNJ-42756493 oral solution on
      Day 1 of Period 2. In Treatment Sequence BA: 100 mcg JNJ-61818549 will be administered
      intravenously after the intake of 10 mg JNJ-42756493 oral solution on Day 1 of Period 1 and
      10 mg JNJ-42756493 tablet formulation will be administered on Day 1 of Period 2. A minimum 12
      days washout is required between treatment periods. Participants will primarily be analyzed
      for pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues
      over time). Participants' safety will be monitored throughout the study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Relative Bioavailability: Maximum Plasma Concentration (Cmax)
time frame: Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose
description: The Cmax is the maximum observed plasma concentration of JNJ-42756493.
measure: Absolute Bioavailability
time frame: Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose
description: Absolute bioavailability will be measured by Area under concentration time-curve (AUC [0-24]), AUC (0-last) and AUC (0-infinity).
measure: Relative Bioavailability: Area under concententration time-curve (AUC)
time frame: Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose
description: Relative bioavailability will be measured by AUC (0-24), AUC (0-last) and AUC (0-infinity).
measure: Time to Reach Maximum Concentration (tmax)
time frame: Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose
description: The tmax is time to reach the maximum observed plasma concentration.
measure: Elimination Half-Life (t1/2)
time frame: Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose
description: Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half.
arm group label: Treatment Sequence AB
arm group type: Experimental
description: Participants will receive 10 milligram (mg) JNJ-42756493 tablet orally on Day 1 of Period 1 and 100 microgram (mcg) of JNJ-61818549 as intravenous injection 2 hours after the intake of 10 mg JNJ-42756493 oral solution on Day 1 of Period 2.
arm group label: Treatment Sequence BA
arm group type: Experimental
description: Participants will receive 100 mcg of JNJ-61818549 as intravenous injection after the intake of 10 mg JNJ-42756493 oral solution on Day 1 of Period 1 and JNJ-42756493 10 mg tablet orally on Day 1 of Period 2.
intervention type: Drug
intervention name: JNJ-42756493 10 mg tablet
description: Participants will be administered with 10 milligram (mg) JNJ-42756493 tablet orally either on Day 1 of Period 1 or on Day 1 of Period 2.
arm group label: Treatment Sequence AB
arm group label: Treatment Sequence BA
intervention type: Drug
intervention name: JNJ-42756493 10 mg Oral Solution
description: Participants will be administered with 10 mg JNJ-42756493 oral solution either on Day 1 of Period 1 or on Day 1 of Period 2.
arm group label: Treatment Sequence AB
arm group label: Treatment Sequence BA
intervention type: Drug
intervention name: JNJ-61818549
description: Participants will receive 100 mcg of JNJ-61818549 as intravenous injection on Day 1 of Period 2 or Day 1 of Period 1.
arm group label: Treatment Sequence AB
arm group label: Treatment Sequence BA
criteria: 
gender: All
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