<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/NCT04480736</url>
  </required_header>
  <id_info>
    <org_study_id>CR108700</org_study_id>
    <secondary_id>64281802DNG2001</secondary_id>
    <nct_id>NCT04480736</nct_id>
  </id_info>
  <brief_title>A Study of JNJ-64281802 Against Dengue Serotype 1 Infection in a Dengue Human Challenge Model in Healthy Adult Participants</brief_title>
  <official_title>A Phase 2a, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics of Repeated Oral Doses of JNJ-64281802 Against Dengue Serotype 1 Infection in a Dengue Human Challenge Model in Healthy Adult Participants</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>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the antiviral activity of JNJ-64281802 versus placebo&#xD;
      in terms of reduction of dengue virus 1 (DENV-1) ribonucleic acid (RNA) viral load (VL).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    The decision has been taken to PAUSE DNG2001 recruitment.&#xD;
  </why_stopped>
  <start_date type="Actual">July 28, 2020</start_date>
  <completion_date type="Anticipated">April 8, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2024</primary_completion_date>
  <phase>Phase 2</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>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the DENV-1 RNA VL-concentration time Curve (VL AUC) from Immediately before Inoculation (Baseline on Day 1) until Day 29</measure>
    <time_frame>Baseline to Day 29</time_frame>
    <description>Area under the dengue virus (DENV)-1 ribonucleic acid (RNA) Viral Load (VL) concentration-time curves from immediately before inoculation (baseline on Day 1) until Day 29 will be reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability</measure>
    <time_frame>Up to Day 85</time_frame>
    <description>An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Clinically Significant Abnormalities in Physical Examination</measure>
    <time_frame>Up to Day 85</time_frame>
    <description>Number of participants with clinically significant abnormalities in physical examination will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Clinically Significant Abnormalities in Vital Signs</measure>
    <time_frame>Up to Day 85</time_frame>
    <description>Number of participants with clinically significant abnormalities in vital signs (body temperature, pulse/heart rate, systolic and diastolic blood pressure) will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECGs)</measure>
    <time_frame>Up to Day 21</time_frame>
    <description>Number of participants with clinically significant abnormalities in electrocardiogram (ECGs) will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters</measure>
    <time_frame>Up to Day 85</time_frame>
    <description>Number of participants with clinically significant abnormalities in laboratory parameters (serum chemistry, hematology, blood coagulation, and urine samples) will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with DENV Infection Associated AEs</measure>
    <time_frame>Up to Day 85</time_frame>
    <description>Number of participants with DENV infection associated AEs will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the log10-transformed DENV 1 RNA VL Concentration-time Curves from Immediately before Inoculation (Baseline on Day 1) until Day 29</measure>
    <time_frame>Baseline to Day 29</time_frame>
    <description>Area under the log10-transformed DENV 1 RNA VL concentration-time curves from immediately before inoculation (baseline on Day 1) until Day 29 will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak of Detectable DENV-1 RNA</measure>
    <time_frame>Up to Day 85</time_frame>
    <description>Peak of detectable DENV-1 RNA will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Detectable DENV-1 RNA</measure>
    <time_frame>Up to Day 85</time_frame>
    <description>Duration of detectable DENV-1 RNA will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Onset of Detectable DENV-1 RNA</measure>
    <time_frame>Up to Day 85</time_frame>
    <description>Time to first onset of detectable DENV-1 RNA will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Detectable DENV-1 RNA</measure>
    <time_frame>Up to Day 85</time_frame>
    <description>Number of participants with detectable DENV-1 RNA will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Viremia Curves from Immediately before Inoculation (Baseline on Day 1) until Day 29</measure>
    <time_frame>Baseline to Day 29</time_frame>
    <description>Area under the viremia curves from immediately before inoculation (baseline on Day 1) until Day 29 will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the log10-transformed Viremia Curves</measure>
    <time_frame>Up to Day 85</time_frame>
    <description>Area under the log10-transformed viremia curves will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak of Detectable Viremia Level</measure>
    <time_frame>Up to Day 85</time_frame>
    <description>Peak of detectable viremia level will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Detectable Viremia</measure>
    <time_frame>Up to Day 85</time_frame>
    <description>Duration of detectable viremia will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Onset of Detectable Viremia</measure>
    <time_frame>Up to Day 85</time_frame>
    <description>Time to first onset of detectable viremia will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Detectable Viremia</measure>
    <time_frame>Up to Day 85</time_frame>
    <description>Number of participants with detectable viremia will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Analyte Concentration (Cmax) of JNJ-64281802</measure>
    <time_frame>Day -5: Predose, 1, 2, 4, 6, 8, 10, 12 hours Postdose; Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose</time_frame>
    <description>Cmax is the maximum observed analyte concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum Observed Analyte Concentration (Cmin) of JNJ-64281802</measure>
    <time_frame>Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose</time_frame>
    <description>Cmin is the minimum observed analyte concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trough Plasma Analyte Concentration (Ctrough) of JNJ-64281802</measure>
    <time_frame>Day -4, 1, 6, 8, 10, and 15: Predose; Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose</time_frame>
    <description>(Ctrough) is defined as observed analyte concentration just prior to the beginning or at the end of a dosing interval.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Analyte Concentration (Cavg) of JNJ-64281802</measure>
    <time_frame>Day -5: Predose, 1, 2, 4, 6, 8, 10, 12 hours postdose; Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose</time_frame>
    <description>Cavg is defined as average analyte concentration over the dosing interval (tau) and will be calculated as AUCtau/Tau.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Analyte Concentration (Tmax) of JNJ-64281802</measure>
    <time_frame>Day -5: Predose, 1, 2, 4, 6, 8, 10, 12 hours postdose; Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose</time_frame>
    <description>Tmax is defined as the actual sampling time to reach the maximum observed plasma analyte concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluctuation Index (FI) of JNJ-64281802</measure>
    <time_frame>Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose</time_frame>
    <description>FI is the percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax-Cmin]/Cavg).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve from Time Zero to End of Dosing Interval (AUCtau)</measure>
    <time_frame>Day -5: Predose, 1, 2, 4, 6, 8, 10, 12 hours postdose; Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose</time_frame>
    <description>The AUCtau is the measure of the plasma analyte concentration from time zero to end of dosing interval. AUC during a dosing interval (τ), calculated by linear-linear trapezoidal summation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Anti DENV-1 Total IgM and IgG Antibody Titers</measure>
    <time_frame>Up to Day 85</time_frame>
    <description>Anti-DENV-1 immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies will be measured using enzyme-linked immunosorbent assay (ELISA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Onset of Anti-DENV-1 Total IgM and IgG Antibody Titers</measure>
    <time_frame>Up to Day 85</time_frame>
    <description>Time to first onset of anti-DENV-1 total IgM and IgG antibody titers will be reported.</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Anticipated">54</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive matching placebo of JNJ-64281802 orally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JNJ-64281802 High dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive high dose of JNJ-64281802 orally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JNJ-64281802 Medium dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive medium dose of JNJ-64281802 orally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JNJ-64281802 Low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive low dose of JNJ-64281802 orally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JNJ-64281802 Dosing Regimen X</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive dosing regimen X of JNJ-64281802 orally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JNJ-64281802 Dosing Regimen Y</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive dosing regimen Y of JNJ-64281802 orally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JNJ-64281802 Dosing Regimen Z</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive dosing regimen Z of JNJ-64281802 orally.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo will be administered orally.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-64281802 High dose</intervention_name>
    <description>JNJ-64281802 high dose will be administered orally.</description>
    <arm_group_label>JNJ-64281802 High dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-64281802 Medium dose</intervention_name>
    <description>JNJ-64281802 medium dose will be administered orally.</description>
    <arm_group_label>JNJ-64281802 Medium dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-64281802 Low dose</intervention_name>
    <description>JNJ-64281802 low dose will be administered orally.</description>
    <arm_group_label>JNJ-64281802 Low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-64281802 Dosing Regimen X</intervention_name>
    <description>JNJ-64281802 dosing regimen X will be administered orally.</description>
    <arm_group_label>JNJ-64281802 Dosing Regimen X</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-64281802 Dosing Regimen Y</intervention_name>
    <description>JNJ-64281802 dosing regimen Y will be administered orally.</description>
    <arm_group_label>JNJ-64281802 Dosing Regimen Y</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-64281802 Dosing Regimen Z</intervention_name>
    <description>JNJ-64281802 dosing regimen Z will be administered orally.</description>
    <arm_group_label>JNJ-64281802 Dosing Regimen Z</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy on the basis of physical examination, medical history, and vital signs&#xD;
             performed at screening. If there are abnormalities, the participant may be included&#xD;
             only if the investigator judges the abnormalities to be not clinically relevant. This&#xD;
             determination must be recorded in the participant's source documents and initialed and&#xD;
             dated by the investigator&#xD;
&#xD;
          -  Must pass the comprehension test (i.e., obtain a passing score of greater than or&#xD;
             equal to (&gt;=) 75 percent (%), with up to 3 attempts in total) indicating that he or&#xD;
             she understands the purpose, procedures, and potential risks and benefits of the&#xD;
             study, after reading the informed consent and after the investigator or designee has&#xD;
             provided detailed information on the study and answered the potential participant's&#xD;
             questions&#xD;
&#xD;
          -  Must have a blood pressure (after the participant is supine for &gt;=5 minutes) between&#xD;
             90 and 140 millimeters of Mercury (mmHg) systolic, extremes included, and less than or&#xD;
             equal to (&lt;=) 90 mmHg diastolic at screening. Two repeat measurements are allowed in&#xD;
             the absence of any other concerning health screening issues&#xD;
&#xD;
          -  Must have a Body mass index (BMI) (weight in kilogram divided by the square of height&#xD;
             in meters) between 18.0 and 33.0 kilogram per meter square (kg/m^2), extremes&#xD;
             included, and a body weight of &gt;=50.0 kg at screening&#xD;
&#xD;
          -  All women of childbearing potential must have a negative highly sensitive serum&#xD;
             (beta-human chorionic gonadotropin) pregnancy test at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergies, hypersensitivity, or intolerance to JNJ-64281802 or its excipients,&#xD;
             to a previous vaccination, or to specific medications/animals for which antigens may&#xD;
             be in the dengue virus (DENV)-1 challenge strain preparations, including shellfish,&#xD;
             fetal bovine serum, L-glutamine, neomycin, and streptomycin&#xD;
&#xD;
          -  Any condition for which, in the opinion of the investigator, participation would not&#xD;
             be in the best interest of the participant (example, compromise the well-being) or&#xD;
             that could prevent, limit, or confound the protocol-specified assessments&#xD;
&#xD;
          -  Received an investigational intervention (including investigational vaccines) or used&#xD;
             an invasive investigational medical device within 6 months before first dose of study&#xD;
             drug, or is currently enrolled in an investigational study, or is planning to be&#xD;
             enrolled in an investigational study within 90 days after last dose of study drug&#xD;
&#xD;
          -  Pregnant, breastfeeding, or planning to become pregnant during the study or within 90&#xD;
             days after last dose of study drug&#xD;
&#xD;
          -  Plans to father a child during the study or within 90 days after last dose of study&#xD;
             drug&#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>
      <name>SUNY Upstate Medical University</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>hVIVO Services Limited</name>
      <address>
        <city>London</city>
        <zip>E1 1JT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>February 14, 2023</last_update_submitted>
  <last_update_submitted_qc>February 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2023</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>Dengue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data sharing policy of the Janssen Pharmaceutical Companies of Johnson &amp; Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu</ipd_description>
    <ipd_url>https://www.janssen.com/clinical-trials/transparency</ipd_url>
  </patient_data>
  <!-- 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/NCT04480736
org study id: CR108700
secondary id: 64281802DNG2001
nct id: NCT04480736
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess the antiviral activity of JNJ-64281802 versus placebo
      in terms of reduction of dengue virus 1 (DENV-1) ribonucleic acid (RNA) viral load (VL).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Area Under the DENV-1 RNA VL-concentration time Curve (VL AUC) from Immediately before Inoculation (Baseline on Day 1) until Day 29
time frame: Baseline to Day 29
description: Area under the dengue virus (DENV)-1 ribonucleic acid (RNA) Viral Load (VL) concentration-time curves from immediately before inoculation (baseline on Day 1) until Day 29 will be reported.
measure: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
time frame: Up to Day 85
description: An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
measure: Number of Participants with Clinically Significant Abnormalities in Physical Examination
time frame: Up to Day 85
description: Number of participants with clinically significant abnormalities in physical examination will be reported.
measure: Number of Participants with Clinically Significant Abnormalities in Vital Signs
time frame: Up to Day 85
description: Number of participants with clinically significant abnormalities in vital signs (body temperature, pulse/heart rate, systolic and diastolic blood pressure) will be reported.
measure: Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECGs)
time frame: Up to Day 21
description: Number of participants with clinically significant abnormalities in electrocardiogram (ECGs) will be reported.
measure: Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
time frame: Up to Day 85
description: Number of participants with clinically significant abnormalities in laboratory parameters (serum chemistry, hematology, blood coagulation, and urine samples) will be reported.
measure: Number of Participants with DENV Infection Associated AEs
time frame: Up to Day 85
description: Number of participants with DENV infection associated AEs will be reported.
measure: Area Under the log10-transformed DENV 1 RNA VL Concentration-time Curves from Immediately before Inoculation (Baseline on Day 1) until Day 29
time frame: Baseline to Day 29
description: Area under the log10-transformed DENV 1 RNA VL concentration-time curves from immediately before inoculation (baseline on Day 1) until Day 29 will be reported.
measure: Peak of Detectable DENV-1 RNA
time frame: Up to Day 85
description: Peak of detectable DENV-1 RNA will be reported.
measure: Duration of Detectable DENV-1 RNA
time frame: Up to Day 85
description: Duration of detectable DENV-1 RNA will be reported.
measure: Time to First Onset of Detectable DENV-1 RNA
time frame: Up to Day 85
description: Time to first onset of detectable DENV-1 RNA will be reported.
measure: Number of Participants with Detectable DENV-1 RNA
time frame: Up to Day 85
description: Number of participants with detectable DENV-1 RNA will be reported.
measure: Area Under the Viremia Curves from Immediately before Inoculation (Baseline on Day 1) until Day 29
time frame: Baseline to Day 29
description: Area under the viremia curves from immediately before inoculation (baseline on Day 1) until Day 29 will be reported.
measure: Area Under the log10-transformed Viremia Curves
time frame: Up to Day 85
description: Area under the log10-transformed viremia curves will be reported.
measure: Peak of Detectable Viremia Level
time frame: Up to Day 85
description: Peak of detectable viremia level will be reported.
measure: Duration of Detectable Viremia
time frame: Up to Day 85
description: Duration of detectable viremia will be reported.
measure: Time to First Onset of Detectable Viremia
time frame: Up to Day 85
description: Time to first onset of detectable viremia will be reported.
measure: Number of Participants with Detectable Viremia
time frame: Up to Day 85
description: Number of participants with detectable viremia will be reported.
measure: Maximum Observed Analyte Concentration (Cmax) of JNJ-64281802
time frame: Day -5: Predose, 1, 2, 4, 6, 8, 10, 12 hours Postdose; Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose
description: Cmax is the maximum observed analyte concentration.
measure: Minimum Observed Analyte Concentration (Cmin) of JNJ-64281802
time frame: Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose
description: Cmin is the minimum observed analyte concentration.
measure: Trough Plasma Analyte Concentration (Ctrough) of JNJ-64281802
time frame: Day -4, 1, 6, 8, 10, and 15: Predose; Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose
description: (Ctrough) is defined as observed analyte concentration just prior to the beginning or at the end of a dosing interval.
measure: Average Analyte Concentration (Cavg) of JNJ-64281802
time frame: Day -5: Predose, 1, 2, 4, 6, 8, 10, 12 hours postdose; Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose
description: Cavg is defined as average analyte concentration over the dosing interval (tau) and will be calculated as AUCtau/Tau.
measure: Time to Reach Maximum Observed Plasma Analyte Concentration (Tmax) of JNJ-64281802
time frame: Day -5: Predose, 1, 2, 4, 6, 8, 10, 12 hours postdose; Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose
description: Tmax is defined as the actual sampling time to reach the maximum observed plasma analyte concentration.
measure: Fluctuation Index (FI) of JNJ-64281802
time frame: Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose
description: FI is the percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax-Cmin]/Cavg).
measure: Area Under the Curve from Time Zero to End of Dosing Interval (AUCtau)
time frame: Day -5: Predose, 1, 2, 4, 6, 8, 10, 12 hours postdose; Day 21: Predose, 1, 2, 4, 6, 8, 12, 24 and 96 hours Postdose
description: The AUCtau is the measure of the plasma analyte concentration from time zero to end of dosing interval. AUC during a dosing interval (τ), calculated by linear-linear trapezoidal summation.
measure: Number of Participants with Anti DENV-1 Total IgM and IgG Antibody Titers
time frame: Up to Day 85
description: Anti-DENV-1 immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies will be measured using enzyme-linked immunosorbent assay (ELISA).
measure: Time to First Onset of Anti-DENV-1 Total IgM and IgG Antibody Titers
time frame: Up to Day 85
description: Time to first onset of anti-DENV-1 total IgM and IgG antibody titers will be reported.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will receive matching placebo of JNJ-64281802 orally.
arm group label: JNJ-64281802 High dose
arm group type: Experimental
description: Participants will receive high dose of JNJ-64281802 orally.
arm group label: JNJ-64281802 Medium dose
arm group type: Experimental
description: Participants will receive medium dose of JNJ-64281802 orally.
arm group label: JNJ-64281802 Low dose
arm group type: Experimental
description: Participants will receive low dose of JNJ-64281802 orally.
arm group label: JNJ-64281802 Dosing Regimen X
arm group type: Experimental
description: Participants will receive dosing regimen X of JNJ-64281802 orally.
arm group label: JNJ-64281802 Dosing Regimen Y
arm group type: Experimental
description: Participants will receive dosing regimen Y of JNJ-64281802 orally.
arm group label: JNJ-64281802 Dosing Regimen Z
arm group type: Experimental
description: Participants will receive dosing regimen Z of JNJ-64281802 orally.
intervention type: Drug
intervention name: Placebo
description: Matching placebo will be administered orally.
arm group label: Placebo
intervention type: Drug
intervention name: JNJ-64281802 High dose
description: JNJ-64281802 high dose will be administered orally.
arm group label: JNJ-64281802 High dose
intervention type: Drug
intervention name: JNJ-64281802 Medium dose
description: JNJ-64281802 medium dose will be administered orally.
arm group label: JNJ-64281802 Medium dose
intervention type: Drug
intervention name: JNJ-64281802 Low dose
description: JNJ-64281802 low dose will be administered orally.
arm group label: JNJ-64281802 Low dose
intervention type: Drug
intervention name: JNJ-64281802 Dosing Regimen X
description: JNJ-64281802 dosing regimen X will be administered orally.
arm group label: JNJ-64281802 Dosing Regimen X
intervention type: Drug
intervention name: JNJ-64281802 Dosing Regimen Y
description: JNJ-64281802 dosing regimen Y will be administered orally.
arm group label: JNJ-64281802 Dosing Regimen Y
intervention type: Drug
intervention name: JNJ-64281802 Dosing Regimen Z
description: JNJ-64281802 dosing regimen Z will be administered orally.
arm group label: JNJ-64281802 Dosing Regimen Z
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: 
facility: 
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Dengue
sharing ipd: Yes
ipd description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
ipd url: https://www.janssen.com/clinical-trials/transparency