<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/NCT01662661</url>
  </required_header>
  <id_info>
    <org_study_id>CR100881</org_study_id>
    <secondary_id>47910382HPC1004</secondary_id>
    <secondary_id>2012-002341-38</secondary_id>
    <nct_id>NCT01662661</nct_id>
  </id_info>
  <brief_title>A Study to Compare the Bioavailability of JNJ-47910382 Formulated as a Tablet and as Suspension in Healthy Participants</brief_title>
  <official_title>A Phase I, Open-Label, Randomized, 2-way Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of a Single Oral Dose of JNJ-47910382 Formulated as a Tablet and as a Suspension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen R&amp;D Ireland</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen R&amp;D Ireland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the relative bioavailability (the degree to which the&#xD;
      study medication becomes available in the blood circulation) of JNJ-47910382, given as an&#xD;
      uncoated tablet and as a suspension, after a single oral dose of 200 mg in healthy adult&#xD;
      participants under fed conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label (all people know the identity of the intervention), randomized (the&#xD;
      study medication is assigned by chance), 2-way crossover study (method used to switch&#xD;
      participants from one treatment arm to another in a clinical study) to compare the oral&#xD;
      bioavailability of JNJ-47910382 formulated as an uncoated tablet and as a suspension, in&#xD;
      healthy participants. The study consists of 3 phases, including, a screening phase, an&#xD;
      open-label treatment phase, and a follow up phase. The screening phase will be within 21 days&#xD;
      before administration of the first dose of study medication. After screening, participants&#xD;
      will be randomized according to a classical 2 sequence (ie, treatment sequence AB [where the&#xD;
      participants will first receive treatment A and then treatment B] and sequence BA [where the&#xD;
      participants will first receive treatment B and then treatment A]), 2-period crossover design&#xD;
      to receive the study medication in the treatment phase. In each session (Session 1 or Session&#xD;
      2), participants will receive either Treatment A: 200 mg dose of JNJ-47910382 formulated as a&#xD;
      suspension, or Treatment B: 200 mg JNJ-47910382 formulated as an uncoated tablet. There will&#xD;
      be a washout period (period when participant is not receiving any study medication) of at&#xD;
      least 7 to 14 days between the 2 sessions. The follow up phase will include 2 follow up&#xD;
      visits after intake of study medication in last treatment session. Safety evaluations for&#xD;
      adverse events, clinical laboratory tests, electrocardiogram, vital signs, physical&#xD;
      examination, and specific toxicities will be monitored throughout the study. The duration of&#xD;
      the study will be at least 11 to 18 days (screening and follow up phase not included).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">August 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum plasma concentration (Cmax)</measure>
    <time_frame>Day 1 (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0 hours), Day 2 (24, 36 hours), Day 3 (48 hours), and Day 4 (72 hours)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to reach the maximum plasma concentration (Tmax)</measure>
    <time_frame>Day 1 (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0 hours), Day 2 (24, 36 hours), Day 3 (48 hours), and Day 4 (72 hours)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve (AUC)</measure>
    <time_frame>Day 1 (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0 hours), Day 2 (24, 36 hours), Day 3 (48 hours), and Day 4 (72 hours)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>Up to 58 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Healthy Participants</condition>
  <arm_group>
    <arm_group_label>Arm AB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment A: 200 mg dose of JNJ-47910382 formulated as a suspension followed by Treatment B: 200 mg JNJ-47910382 formulated as an uncoated tablet, administered on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm BA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment B: 200 mg JNJ-47910382 formulated as an uncoated tablet followed by Treatment A: 200 mg dose of JNJ-47910382 formulated as a suspension, administered on Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-47910382 (suspension)</intervention_name>
    <description>Type=exact number, unit=mg, number=200, form=suspension, route=oral. JNJ-47910382 administered on Day 1.</description>
    <arm_group_label>Arm AB</arm_group_label>
    <arm_group_label>Arm BA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-47910382 (tablet)</intervention_name>
    <description>Type=exact number, unit=mg, number=200, form=tablet, route=oral. JNJ-47910382 administered on Day 1.</description>
    <arm_group_label>Arm AB</arm_group_label>
    <arm_group_label>Arm BA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be healthy on the basis of physical examination, medical history, vital signs and&#xD;
             the results of blood biochemistry, hematology and coagulation tests and a urinalysis&#xD;
             performed (at screening)&#xD;
&#xD;
          -  Must have a triplicate 12-lead electrocardiogram consistent with normal cardiac&#xD;
             conduction and function&#xD;
&#xD;
          -  Must be a non-smoker for at least 3 months prior to selection&#xD;
&#xD;
          -  If a female, must be postmenopausal or surgically sterile&#xD;
&#xD;
          -  Female participants must have a negative serum pregnancy test (at screening)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Had a past history of heart arrhythmias, history of risk factors for Torsade de&#xD;
             Pointes syndrome (an uncommon and distinctive form of polymorphic ventricular&#xD;
             tachycardia characterized by a gradual change in the amplitude and twisting of the QRS&#xD;
             complexes around the isoelectric line on the electrocardiogram) or having low&#xD;
             potassium levels in the blood&#xD;
&#xD;
          -  History or suspicion of alcohol, barbiturate, amphetamine, recreational or narcotic&#xD;
             drug use that could impact compliance to protocol requirements and/or safety&#xD;
&#xD;
          -  Hepatitis A, B or C infection (at screening)&#xD;
&#xD;
          -  A positive human immunodeficiency virus type 1 or 2 (HIV-1 or HIV-2) test (at&#xD;
             screening)&#xD;
&#xD;
          -  Have a positive urine drug test or alcohol breath test (at screening)&#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>Antwerp</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>July 22, 2013</last_update_submitted>
  <last_update_submitted_qc>July 22, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 24, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy participants</keyword>
  <keyword>Hepatitis C</keyword>
  <keyword>Relative bioavailability</keyword>
  <keyword>Bioavailability</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>JNJ-47910382</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/NCT01662661
org study id: CR100881
secondary id: 47910382HPC1004
secondary id: 2012-002341-38
nct id: NCT01662661
lead sponsor: 
has dmc: No
The purpose of this study is to assess the relative bioavailability (the degree to which the
      study medication becomes available in the blood circulation) of JNJ-47910382, given as an
      uncoated tablet and as a suspension, after a single oral dose of 200 mg in healthy adult
      participants under fed conditions.
This is an open-label (all people know the identity of the intervention), randomized (the
      study medication is assigned by chance), 2-way crossover study (method used to switch
      participants from one treatment arm to another in a clinical study) to compare the oral
      bioavailability of JNJ-47910382 formulated as an uncoated tablet and as a suspension, in
      healthy participants. The study consists of 3 phases, including, a screening phase, an
      open-label treatment phase, and a follow up phase. The screening phase will be within 21 days
      before administration of the first dose of study medication. After screening, participants
      will be randomized according to a classical 2 sequence (ie, treatment sequence AB [where the
      participants will first receive treatment A and then treatment B] and sequence BA [where the
      participants will first receive treatment B and then treatment A]), 2-period crossover design
      to receive the study medication in the treatment phase. In each session (Session 1 or Session
      2), participants will receive either Treatment A: 200 mg dose of JNJ-47910382 formulated as a
      suspension, or Treatment B: 200 mg JNJ-47910382 formulated as an uncoated tablet. There will
      be a washout period (period when participant is not receiving any study medication) of at
      least 7 to 14 days between the 2 sessions. The follow up phase will include 2 follow up
      visits after intake of study medication in last treatment session. Safety evaluations for
      adverse events, clinical laboratory tests, electrocardiogram, vital signs, physical
      examination, and specific toxicities will be monitored throughout the study. The duration of
      the study will be at least 11 to 18 days (screening and follow up phase not included).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum plasma concentration (Cmax)
time frame: Day 1 (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0 hours), Day 2 (24, 36 hours), Day 3 (48 hours), and Day 4 (72 hours)
measure: Time to reach the maximum plasma concentration (Tmax)
time frame: Day 1 (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0 hours), Day 2 (24, 36 hours), Day 3 (48 hours), and Day 4 (72 hours)
measure: Area under the plasma concentration-time curve (AUC)
time frame: Day 1 (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0 hours), Day 2 (24, 36 hours), Day 3 (48 hours), and Day 4 (72 hours)
measure: Number of participants with adverse events
time frame: Up to 58 days
arm group label: Arm AB
arm group type: Experimental
description: Treatment A: 200 mg dose of JNJ-47910382 formulated as a suspension followed by Treatment B: 200 mg JNJ-47910382 formulated as an uncoated tablet, administered on Day 1.
arm group label: Arm BA
arm group type: Experimental
description: Treatment B: 200 mg JNJ-47910382 formulated as an uncoated tablet followed by Treatment A: 200 mg dose of JNJ-47910382 formulated as a suspension, administered on Day 1.
intervention type: Drug
intervention name: JNJ-47910382 (suspension)
description: Type=exact number, unit=mg, number=200, form=suspension, route=oral. JNJ-47910382 administered on Day 1.
arm group label: Arm AB
arm group label: Arm BA
intervention type: Drug
intervention name: JNJ-47910382 (tablet)
description: Type=exact number, unit=mg, number=200, form=tablet, route=oral. JNJ-47910382 administered on Day 1.
arm group label: Arm AB
arm group label: Arm 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