<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/NCT02230878</url>
  </required_header>
  <id_info>
    <org_study_id>CR104154</org_study_id>
    <secondary_id>42847922EDI1003</secondary_id>
    <secondary_id>2014-000600-95</secondary_id>
    <nct_id>NCT02230878</nct_id>
  </id_info>
  <brief_title>A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-42847922 in Healthy Participants</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-42847922 in Healthy Male and Female 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 this study is to investigate the safety, tolerability, pharmacokinetic (the&#xD;
      study of the way a drug enters and leaves the blood and tissues over time),&#xD;
      dose-proportionality, accumulation, urinary excretion, pharmacodynamics (the study of how&#xD;
      drugs act on the body) and sedative effects of JNJ-42847922 in healthy male and female&#xD;
      participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 1, double blind (a medical research study in which neither the researchers&#xD;
      nor the participants know what treatment the participants is receiving), randomized (study&#xD;
      drug assigned by chance), placebo controlled, multiple ascending dose study. The study will&#xD;
      consist of 3 parts: a Screening period (Days -21 to -2), a Double-blind treatment period (Day&#xD;
      -1 to Day 11), and a Follow-up period (within 7 to 14 days after last dose administration).&#xD;
      In double blind treatment period, participants will be randomly assigned to 5, 10, 20, and 40&#xD;
      milligram (mg) or placebo. Number of participants with any clinically relevant changes&#xD;
      (adverse events [AEs], laboratory results,electrocardiogram [ECG], Vital signs, Physical and&#xD;
      neurological, sedation &amp; concentration) and columbia suicide severity rating (CSSR) scale&#xD;
      will be evaluated as primary outcome measure. Participants' safety will be monitored&#xD;
      throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Supine and Standing Systolic and Diastolic Blood Pressure (BP)</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
    <description>BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Supine and Standing Heart Rate</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Tympanic Temperature</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>12 Lead Electrocardiogram (ECG): RR, QRS, PR, QT, QTcB, QTcF Interval</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Columbia Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with Adverse Events</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Change From Baseline in Laboratory Tests Results</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
    <description>Laboratory values included Hematology, clinical chemistry and urinalysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical and Neurological Examination</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
    <description>Physical and neurological examination will be performed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Plasma Concentration (C[max])</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
    <description>The C(max) is the maximum plasma concentration which will be observed at the defined time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach the Maximum Plasma Concentration (T[max])</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
    <description>The T[max] is time to reach the observed maximum plasma concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Last Quantifiable Plasma Concentration (T[last])</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
    <description>The T[last] is time to reach the observed maximum plasma concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration-Time Curve From Time Zero to hour 24 Time (AUC [0-24])</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
    <description>AUC (0-24) is the area under the plasma concentration-time curve from time 0 to 24 hours post-dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last])</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
    <description>AUC (last) is the area under the plasma concentration-time curve from time zero time of the last quantifiable concentration C(last), and C(last) is the last observed quantifiable concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
    <description>AUC (infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Plasma Concentration at Steady-State (C[avg])</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
    <description>C(avg) is the average plasma concentration at steady state, calculated as AUC 0-24 divided by 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trough Plasma Concentration (C[trough])</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
    <description>Trough plasma concentration is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Clearance (CL/F)</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
    <description>CL/F is the total clearance of drug after extravascular administration, uncorrected for absolute bioavailability. It is calculated as Dose divided by AUC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of Distribution (Vd/F)</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
    <description>Vd/F is the volume of distribution after extravascular administration, uncorrected for absolute bioavailability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elimination Half-life Period (t1/2)</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
    <description>Elimination half-life associated with the terminal slope (lambda[z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda (z).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal slope (Lambda [z])</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
    <description>Terminal slope is defined by first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Residence Time (MRT)</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
    <description>MRT is the mean residence time calculated as area under the first moment curve at infinity (AUMC[0-∞]) divided by AUC[0-∞].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of Drug Excreted in Urine (Ae)</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
    <description>Ae is the amount of urine excreted in urine. It is calculated by multiplying the urinary volume with the urinary concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of Drug Excreted into Urine During the 24-hour Dosing Interval (Ae[0-24])</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
    <description>Ae(0-24h) is the amount of drug excreted into urine during the 24-hour dosing interval.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Drug Excreted in Urine (Ae%dose)</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
    <description>Ae%dose is the percentage of drug excreted into the urine calculated as (Ae divided by dose)∗100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal Clearance (CL[R])</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
    <description>CL(R) is the renal clearance of the drug, calculated as Ae/AUC[0-infinity] on Day 1 or Ae(0-24)/AUC(0-24) on Day 5 and Day 10.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Assessment of Sedation</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
    <description>Sedation will be assessed using a reaction time (RT) test battery, the Critical Flicker Fusion (CFF) test and body sway.</description>
  </other_outcome>
  <other_outcome>
    <measure>Bond and Lader Visual Analogue Scale (B and L VAS)</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
    <description>The B and L VAS includes 16 questions with VAS scales to rate subjective feelings.</description>
  </other_outcome>
  <other_outcome>
    <measure>Addiction Research Center Inventory Questionnaire (ARCI-49)</measure>
    <time_frame>Baseline up to End of study (7-14 days after last dose) or Early withdrawal</time_frame>
    <description>The ARCI-49 item questionnaire is developed specifically to measure subjective effects of drugs with diverse pharmacological actions.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>JNJ-42847922, 5 milligram (mg) and Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be receive either 5 mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JNJ-42847922, 10 mg and Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be receive either 10 mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JNJ-42847922, 20 mg and Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be receive either 20 mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JNJ-42847922, 40 mg and Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be receive either 40mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-42847922 5 mg</intervention_name>
    <description>Participants will receive 5 mg of JNJ-42847922, from Day 1 up to Day 10.</description>
    <arm_group_label>JNJ-42847922, 5 milligram (mg) and Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-42847922 10 mg</intervention_name>
    <description>Participants will receive 10 mg of JNJ-42847922, from Day 1 up to Day 10.</description>
    <arm_group_label>JNJ-42847922, 10 mg and Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-42847922 20 mg</intervention_name>
    <description>Participants will receive 20 mg of JNJ-42847922, from Day 1 up to Day 10.</description>
    <arm_group_label>JNJ-42847922, 20 mg and Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-42847922 40 mg</intervention_name>
    <description>Participants will receive 40 mg of JNJ-42847922, from Day 1 up to Day 10 .</description>
    <arm_group_label>JNJ-42847922, 40 mg and Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive matching placebo from Day 1 up to Day 10.</description>
    <arm_group_label>JNJ-42847922, 10 mg and Placebo</arm_group_label>
    <arm_group_label>JNJ-42847922, 20 mg and Placebo</arm_group_label>
    <arm_group_label>JNJ-42847922, 40 mg and Placebo</arm_group_label>
    <arm_group_label>JNJ-42847922, 5 milligram (mg) and Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women should not be of child bearing potential due to either tubal ligation or&#xD;
             hysterectomy or who are postmenopausal (no spontaneous menses for at least 2 years&#xD;
&#xD;
          -  Body Mass Index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) inclusive&#xD;
             (BMI=weight/height^2)&#xD;
&#xD;
          -  Participants must be healthy / medically stable on the basis of clinical laboratory&#xD;
             tests performed at screening. If the results of the serum chemistry panel, hematology,&#xD;
             or urinalysis are outside the normal reference ranges, retesting of an abnormal lab&#xD;
             value(s) that may lead to exclusion will be allowed once during the screening phase&#xD;
&#xD;
          -  Non-smokers (not smoked for 6 months prior to screening)&#xD;
&#xD;
          -  Participant must be willing and able to adhere to the prohibitions and restrictions&#xD;
             specified in this protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically significant abnormal values for hematology, serum chemistry or urinalysis&#xD;
             at screening or admission&#xD;
&#xD;
          -  Clinically significant abnormal physical or 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, hematological disease, lipid&#xD;
             abnormalities, bronchospastic respiratory disease, diabetes mellitus, renal or hepatic&#xD;
             insufficiency, thyroid disease, Parkinson's disease, infection, or any other illness&#xD;
             that the Investigator considers should exclude the participant&#xD;
&#xD;
          -  Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV)&#xD;
             antibodies or human immunodeficiency virus (HIV) antibodies&#xD;
&#xD;
          -  Subjects with a relevant history of a suicide attempt or suicidal behavior. Any recent&#xD;
             suicidal ideation within the last 6 months (a level of 4 or 5), or who are at&#xD;
             significant risk to commit suicide, as judged by the investigator using the columbia&#xD;
             suicide severity rating score (C-SSRS)&#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-Cilag International NV Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen-Cilag International NV</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>January 21, 2017</last_update_submitted>
  <last_update_submitted_qc>January 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>JNJ-42847922</keyword>
  <keyword>Phase 1</keyword>
  <keyword>Healthy</keyword>
  <keyword>Placebo</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/NCT02230878
org study id: CR104154
secondary id: 42847922EDI1003
secondary id: 2014-000600-95
nct id: NCT02230878
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the safety, tolerability, pharmacokinetic (the
      study of the way a drug enters and leaves the blood and tissues over time),
      dose-proportionality, accumulation, urinary excretion, pharmacodynamics (the study of how
      drugs act on the body) and sedative effects of JNJ-42847922 in healthy male and female
      participants.
This is a Phase 1, double blind (a medical research study in which neither the researchers
      nor the participants know what treatment the participants is receiving), randomized (study
      drug assigned by chance), placebo controlled, multiple ascending dose study. The study will
      consist of 3 parts: a Screening period (Days -21 to -2), a Double-blind treatment period (Day
      -1 to Day 11), and a Follow-up period (within 7 to 14 days after last dose administration).
      In double blind treatment period, participants will be randomly assigned to 5, 10, 20, and 40
      milligram (mg) or placebo. Number of participants with any clinically relevant changes
      (adverse events [AEs], laboratory results,electrocardiogram [ECG], Vital signs, Physical and
      neurological, sedation & concentration) and columbia suicide severity rating (CSSR) scale
      will be evaluated as primary outcome measure. Participants' safety will be monitored
      throughout the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Supine and Standing Systolic and Diastolic Blood Pressure (BP)
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
description: BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles).
measure: Supine and Standing Heart Rate
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
measure: Tympanic Temperature
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
measure: 12 Lead Electrocardiogram (ECG): RR, QRS, PR, QT, QTcB, QTcF Interval
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
measure: Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
measure: Number of Participants with Adverse Events
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
measure: Number of Participants With Change From Baseline in Laboratory Tests Results
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
description: Laboratory values included Hematology, clinical chemistry and urinalysis.
measure: Physical and Neurological Examination
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
description: Physical and neurological examination will be performed.
measure: Maximum Plasma Concentration (C[max])
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
description: The C(max) is the maximum plasma concentration which will be observed at the defined time points.
measure: Time to Reach the Maximum Plasma Concentration (T[max])
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
description: The T[max] is time to reach the observed maximum plasma concentration.
measure: Time to Reach Last Quantifiable Plasma Concentration (T[last])
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
description: The T[last] is time to reach the observed maximum plasma concentration.
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to hour 24 Time (AUC [0-24])
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
description: AUC (0-24) is the area under the plasma concentration-time curve from time 0 to 24 hours post-dose.
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last])
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
description: AUC (last) is the area under the plasma concentration-time curve from time zero time of the last quantifiable concentration C(last), and C(last) is the last observed quantifiable concentration.
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
description: AUC (infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
measure: Average Plasma Concentration at Steady-State (C[avg])
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
description: C(avg) is the average plasma concentration at steady state, calculated as AUC 0-24 divided by 24
measure: Trough Plasma Concentration (C[trough])
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
description: Trough plasma concentration is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose.
measure: Total Clearance (CL/F)
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
description: CL/F is the total clearance of drug after extravascular administration, uncorrected for absolute bioavailability. It is calculated as Dose divided by AUC.
measure: Volume of Distribution (Vd/F)
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
description: Vd/F is the volume of distribution after extravascular administration, uncorrected for absolute bioavailability.
measure: Elimination Half-life Period (t1/2)
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
description: Elimination half-life associated with the terminal slope (lambda[z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda (z).
measure: Terminal slope (Lambda [z])
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
description: Terminal slope is defined by first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
measure: Mean Residence Time (MRT)
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
description: MRT is the mean residence time calculated as area under the first moment curve at infinity (AUMC[0-∞]) divided by AUC[0-∞].
measure: Amount of Drug Excreted in Urine (Ae)
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
description: Ae is the amount of urine excreted in urine. It is calculated by multiplying the urinary volume with the urinary concentration.
measure: Amount of Drug Excreted into Urine During the 24-hour Dosing Interval (Ae[0-24])
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
description: Ae(0-24h) is the amount of drug excreted into urine during the 24-hour dosing interval.
measure: Percentage of Drug Excreted in Urine (Ae%dose)
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
description: Ae%dose is the percentage of drug excreted into the urine calculated as (Ae divided by dose)∗100.
measure: Renal Clearance (CL[R])
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
description: CL(R) is the renal clearance of the drug, calculated as Ae/AUC[0-infinity] on Day 1 or Ae(0-24)/AUC(0-24) on Day 5 and Day 10.
measure: Assessment of Sedation
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
description: Sedation will be assessed using a reaction time (RT) test battery, the Critical Flicker Fusion (CFF) test and body sway.
measure: Bond and Lader Visual Analogue Scale (B and L VAS)
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
description: The B and L VAS includes 16 questions with VAS scales to rate subjective feelings.
measure: Addiction Research Center Inventory Questionnaire (ARCI-49)
time frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
description: The ARCI-49 item questionnaire is developed specifically to measure subjective effects of drugs with diverse pharmacological actions.
arm group label: JNJ-42847922, 5 milligram (mg) and Placebo
arm group type: Experimental
description: Participants will be receive either 5 mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10.
arm group label: JNJ-42847922, 10 mg and Placebo
arm group type: Experimental
description: Participants will be receive either 10 mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10.
arm group label: JNJ-42847922, 20 mg and Placebo
arm group type: Experimental
description: Participants will be receive either 20 mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10.
arm group label: JNJ-42847922, 40 mg and Placebo
arm group type: Experimental
description: Participants will be receive either 40mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10.
intervention type: Drug
intervention name: JNJ-42847922 5 mg
description: Participants will receive 5 mg of JNJ-42847922, from Day 1 up to Day 10.
arm group label: JNJ-42847922, 5 milligram (mg) and Placebo
intervention type: Drug
intervention name: JNJ-42847922 10 mg
description: Participants will receive 10 mg of JNJ-42847922, from Day 1 up to Day 10.
arm group label: JNJ-42847922, 10 mg and Placebo
intervention type: Drug
intervention name: JNJ-42847922 20 mg
description: Participants will receive 20 mg of JNJ-42847922, from Day 1 up to Day 10.
arm group label: JNJ-42847922, 20 mg and Placebo
intervention type: Drug
intervention name: JNJ-42847922 40 mg
description: Participants will receive 40 mg of JNJ-42847922, from Day 1 up to Day 10 .
arm group label: JNJ-42847922, 40 mg and Placebo
intervention type: Drug
intervention name: Placebo
description: Participants will receive matching placebo from Day 1 up to Day 10.
arm group label: JNJ-42847922, 10 mg and Placebo
arm group label: JNJ-42847922, 20 mg and Placebo
arm group label: JNJ-42847922, 40 mg and Placebo
arm group label: JNJ-42847922, 5 milligram (mg) and Placebo
criteria: 
gender: All
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
facility: 
country: Germany
responsible party type: Sponsor