<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/NCT02231489</url>
  </required_header>
  <id_info>
    <org_study_id>CR105269</org_study_id>
    <secondary_id>42756493EDI1003</secondary_id>
    <secondary_id>2014-002635-33</secondary_id>
    <nct_id>NCT02231489</nct_id>
  </id_info>
  <brief_title>Study to Assess the Relative Bioavailability of Orally Administered JNJ-42756493 Tablet Versus JNJ-42756493 Capsule 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 Tablet Versus Capsule 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 relative bioavailability of JNJ-42756493 oral&#xD;
      dose of capsule (reference) versus tablet (test) in healthy participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 1, randomized (study drug assigned by chance), open-label (all people know&#xD;
      the identity of the intervention), 2 way crossover (method used to switch participants from&#xD;
      one study group change to treatment group), single-dose study in healthy participants. The&#xD;
      study will consist of 3 phases: Screening Phase (Day -21 to Day -2), Treatment Phase&#xD;
      (consists of 2 single-dose treatment period, either JNJ-42756493 capsule or JNJ-42756493&#xD;
      tablet) and Follow-up Phase (12-14 days after last dose). All the eligible participants will&#xD;
      be randomly assigned to 1 of the 2 treatment sequences to ensure that they receive both of&#xD;
      the treatments, 1 in each period. Each treatment regimen will be separated by a washout&#xD;
      period of at least 15 days. Blood samples will be collected for evaluation of&#xD;
      pharmacokinetics at pre-dose and post-dose of study treatment. Relative bioavailability of&#xD;
      two dosage form of JNJ-42756493 (test and reference) will be evaluated primarily.&#xD;
      Participants' safety will be monitored throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absolute Bioavailability (F[abs]) of JNJ-42756493</measure>
    <time_frame>Pre-dose;15,30,60,120,130,140,150 and 165 minutes (min),3,4,6,8,12,24,32,48,72,96,120, 144 hours (hrs) post-dose on Day 1 in Treatment Period 1; pre-dose;, 0.25,0.5,1,2,3,4,6,8,12,24,32,48,72,96,120,144 post-dose on Day 1 in Treatment Period 2</time_frame>
    <description>The F (abs) is the percentage of the orally administered dose that is systemically available. It is calculated as (AUC [0-infinity] for test)/(AUC [0-infinity] for reference [ref])*(D for ref/D for test )*100, where the reference treatment is an intravenous administration, AUC (0-infinity) is area under the concentration-time curve from time zero to extrapolated infinite time, and D is the dose of orally administered drug.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Relative Bioavailability (F[rel]) of JNJ-42756493</measure>
    <time_frame>Pre-dose;15,30,60,120,130,140,150 and 165 minutes (min),3,4,6,8,12,24,32,48,72,96,120, 144 hours (hrs) post-dose on Day 1 in Treatment Period 1; pre-dose;, 0.25,0.5,1,2,3,4,6,8,12,24,32,48,72,96,120,144 post-dose on Day 1 in Treatment Period 2</time_frame>
    <description>The F (rel) is the percentage of the orally administered dose that is systemically available. It is calculated as (AUC [0-infinity] for test)/(AUC [0-infinity] for reference [ref])*(D for test/D for ref )*100, where the reference treatment is an intravenous administration, AUC (0-infinity) is area under the concentration-time curve from time zero to extrapolated infinite time, and D is the dose of orally administered drug.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Plasma Concentration (Cmax) of JNJ-42756493</measure>
    <time_frame>Pre-dose;15,30,60,120,130,140,150 and 165 minutes (min),3,4,6,8,12,24,32,48,72,96,120, 144 hours (hrs) post-dose on Day 1 in Treatment Period 1; pre-dose;, 0.25,0.5,1,2,3,4,6,8,12,24,32,48,72,96,120,144 post-dose on Day 1 in Treatment Period 2</time_frame>
    <description>The Cmax is the maximum plasma concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Concentration (tmax)</measure>
    <time_frame>Pre-dose;15,30,60,120,130,140,150 and 165 minutes (min),3,4,6,8,12,24,32,48,72,96,120, 144 hours (hrs) post-dose on Day 1 in Treatment Period 1; pre-dose;, 0.25,0.5,1,2,3,4,6,8,12,24,32,48,72,96,120,144 post-dose on Day 1 in Treatment Period 2</time_frame>
    <description>Time to reach the maximum plasma JNJ4-2756493 concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elimination Half-Life (t [1/2] Lambda)</measure>
    <time_frame>Pre-dose;15,30,60,120,130,140,150 and 165 minutes (min),3,4,6,8,12,24,32,48,72,96,120, 144 hours (hrs) post-dose on Day 1 in Treatment Period 1; pre-dose;, 0.25,0.5,1,2,3,4,6,8,12,24,32,48,72,96,120,144 post-dose on Day 1 in Treatment Period 2</time_frame>
    <description>Elimination half-life (t [1/2] Lambda) is associated with the terminal slope (lambda [z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</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 treatment A (JNJ-42756493 tablet 10 milligram [mg] as single oral dose) along with JNJ-61818549, 100 microgram (mcg) intravenous infusion over 5 minutes, 2 hours after administration of JNJ-42756493 tablet on Day 1 in Treatment Period 1. Participants will receive treatment B (JNJ-42756493 capsule 10 mg as single oral dose) on Day 1 of Treatment 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 treatment B (JNJ-42756493 capsule 10 mg as single oral dose) along with 100 microgram (mcg) intravenous infusion over 5 minutes, 2 hours after administration of JNJ-42756493 capsule on Day 1 in Treatment Period 1. Participants will receive treatment A (JNJ-42756493 tablet as single oral dose) on Day 1 of Treatment Period 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-42756493 Tablet</intervention_name>
    <description>Participants will receive 10 mg of JNJ-42756493 tablet as single oral dose on Day 1 of each treatment period.</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 Capsule</intervention_name>
    <description>Participants will receive 10 mg of JNJ-42756493 capsule as single oral dose on Day 1 of each treatment period.</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 JNJ-61818549, 100 microgram (mcg) intravenous infusion over 5 minutes, after 2 hours of administration of JNJ-42756493 tablet/capsule on Day 1 Treatment 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;
          -  Participants who have received a thorough explanation of the optional pharmacogenomic&#xD;
             research component of the study and was offered an opportunity to participate by&#xD;
             signing the separate pharmacogenomic informed consent document&#xD;
&#xD;
          -  Female participants must be postmenopausal (no spontaneous menses for at least 2&#xD;
             years, or surgically sterile and must have a negative serum beta human chorionic&#xD;
             gonadotropin (hCG) pregnancy test at screening&#xD;
&#xD;
          -  Male participants must agree to use an adequate contraception method as deemed&#xD;
             appropriate by the investigator (for example, vasectomy, double-barrier, partner using&#xD;
             effective contraception) and to not donate sperm during the study and for 3 months&#xD;
             after receiving the last dose of study drug&#xD;
&#xD;
          -  Participant must have body mass index (BMI) (weight [kilogram {kg}]/height^2 [m^2])&#xD;
             between 18 and 30 kg/m^2 (inclusive), and body weight not less than 50 kg&#xD;
&#xD;
          -  Participants must be non-smoker for at least 6 months before entering the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with a history of or current clinically significant medical illness&#xD;
             including (but not limited to) cardiac arrhythmias or other cardiac disease,&#xD;
             hematologic disease, coagulation disorders (including any abnormal bleeding or blood&#xD;
             dyscrasias), lipid abnormalities, significant pulmonary disease, including&#xD;
             bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency,&#xD;
             thyroid disease, neurologic or psychiatric disease, metabolic bone disease, infection,&#xD;
             or any other illness that the investigator considers should exclude the participant or&#xD;
             that could interfere with the interpretation of the study results&#xD;
&#xD;
          -  Participants with history or current evidence of ophthalmic disorder, such as central&#xD;
             serous retinopathy or retinal vein occlusion, active wet age related macular&#xD;
             degeneration, diabetic retinopathy with macular edema, uncontrolled glaucoma, corneal&#xD;
             pathology such as keratitis, keratoconjunctivitis, keratopathy, corneal abrasion,&#xD;
             inflammation or ulceration&#xD;
&#xD;
          -  Participants with the use of any prescription or nonprescription medication (including&#xD;
             vitamins and herbal supplements), except for paracetamol and hormonal replacement&#xD;
             therapy within 14 days before the first dose of the study drug is scheduled&#xD;
&#xD;
          -  Participants with positive test for drugs of abuse, such as cannabinoids, alcohol,&#xD;
             opiates, cocaine, amphetamines, benzodiazepines, hallucinogens or barbiturates at&#xD;
             screening and on Day-1 of the first treatment period&#xD;
&#xD;
          -  Participants with clinically significant abnormal values for hematology, clinical&#xD;
             chemistry or urinalysis at screening or at admission to the study center as deemed&#xD;
             appropriate by the investigator. Retesting of abnormal lab values that may lead to&#xD;
             exclusion will be allowed once&#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 Trials</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Antwerpen</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>September 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>December 2, 2014</last_update_submitted>
  <last_update_submitted_qc>December 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 3, 2014</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>
  <!-- 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/NCT02231489
org study id: CR105269
secondary id: 42756493EDI1003
secondary id: 2014-002635-33
nct id: NCT02231489
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the relative bioavailability of JNJ-42756493 oral
      dose of capsule (reference) versus tablet (test) in healthy participants.
This is a Phase 1, randomized (study drug assigned by chance), open-label (all people know
      the identity of the intervention), 2 way crossover (method used to switch participants from
      one study group change to treatment group), single-dose study in healthy participants. The
      study will consist of 3 phases: Screening Phase (Day -21 to Day -2), Treatment Phase
      (consists of 2 single-dose treatment period, either JNJ-42756493 capsule or JNJ-42756493
      tablet) and Follow-up Phase (12-14 days after last dose). All the eligible participants will
      be randomly assigned to 1 of the 2 treatment sequences to ensure that they receive both of
      the treatments, 1 in each period. Each treatment regimen will be separated by a washout
      period of at least 15 days. Blood samples will be collected for evaluation of
      pharmacokinetics at pre-dose and post-dose of study treatment. Relative bioavailability of
      two dosage form of JNJ-42756493 (test and reference) will be evaluated primarily.
      Participants' safety will be monitored throughout the study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Absolute Bioavailability (F[abs]) of JNJ-42756493
time frame: Pre-dose;15,30,60,120,130,140,150 and 165 minutes (min),3,4,6,8,12,24,32,48,72,96,120, 144 hours (hrs) post-dose on Day 1 in Treatment Period 1; pre-dose;, 0.25,0.5,1,2,3,4,6,8,12,24,32,48,72,96,120,144 post-dose on Day 1 in Treatment Period 2
description: The F (abs) is the percentage of the orally administered dose that is systemically available. It is calculated as (AUC [0-infinity] for test)/(AUC [0-infinity] for reference [ref])*(D for ref/D for test )*100, where the reference treatment is an intravenous administration, AUC (0-infinity) is area under the concentration-time curve from time zero to extrapolated infinite time, and D is the dose of orally administered drug.
measure: Relative Bioavailability (F[rel]) of JNJ-42756493
time frame: Pre-dose;15,30,60,120,130,140,150 and 165 minutes (min),3,4,6,8,12,24,32,48,72,96,120, 144 hours (hrs) post-dose on Day 1 in Treatment Period 1; pre-dose;, 0.25,0.5,1,2,3,4,6,8,12,24,32,48,72,96,120,144 post-dose on Day 1 in Treatment Period 2
description: The F (rel) is the percentage of the orally administered dose that is systemically available. It is calculated as (AUC [0-infinity] for test)/(AUC [0-infinity] for reference [ref])*(D for test/D for ref )*100, where the reference treatment is an intravenous administration, AUC (0-infinity) is area under the concentration-time curve from time zero to extrapolated infinite time, and D is the dose of orally administered drug.
measure: Maximum Plasma Concentration (Cmax) of JNJ-42756493
time frame: Pre-dose;15,30,60,120,130,140,150 and 165 minutes (min),3,4,6,8,12,24,32,48,72,96,120, 144 hours (hrs) post-dose on Day 1 in Treatment Period 1; pre-dose;, 0.25,0.5,1,2,3,4,6,8,12,24,32,48,72,96,120,144 post-dose on Day 1 in Treatment Period 2
description: The Cmax is the maximum plasma concentration.
measure: Time to Reach Maximum Concentration (tmax)
time frame: Pre-dose;15,30,60,120,130,140,150 and 165 minutes (min),3,4,6,8,12,24,32,48,72,96,120, 144 hours (hrs) post-dose on Day 1 in Treatment Period 1; pre-dose;, 0.25,0.5,1,2,3,4,6,8,12,24,32,48,72,96,120,144 post-dose on Day 1 in Treatment Period 2
description: Time to reach the maximum plasma JNJ4-2756493 concentration.
measure: Elimination Half-Life (t [1/2] Lambda)
time frame: Pre-dose;15,30,60,120,130,140,150 and 165 minutes (min),3,4,6,8,12,24,32,48,72,96,120, 144 hours (hrs) post-dose on Day 1 in Treatment Period 1; pre-dose;, 0.25,0.5,1,2,3,4,6,8,12,24,32,48,72,96,120,144 post-dose on Day 1 in Treatment Period 2
description: Elimination half-life (t [1/2] Lambda) is associated with the terminal slope (lambda [z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
arm group label: Treatment Sequence AB
arm group type: Experimental
description: Participants will receive treatment A (JNJ-42756493 tablet 10 milligram [mg] as single oral dose) along with JNJ-61818549, 100 microgram (mcg) intravenous infusion over 5 minutes, 2 hours after administration of JNJ-42756493 tablet on Day 1 in Treatment Period 1. Participants will receive treatment B (JNJ-42756493 capsule 10 mg as single oral dose) on Day 1 of Treatment Period 2.
arm group label: Treatment Sequence BA
arm group type: Experimental
description: Participants will receive treatment B (JNJ-42756493 capsule 10 mg as single oral dose) along with 100 microgram (mcg) intravenous infusion over 5 minutes, 2 hours after administration of JNJ-42756493 capsule on Day 1 in Treatment Period 1. Participants will receive treatment A (JNJ-42756493 tablet as single oral dose) on Day 1 of Treatment Period 2.
intervention type: Drug
intervention name: JNJ-42756493 Tablet
description: Participants will receive 10 mg of JNJ-42756493 tablet as single oral dose on Day 1 of each treatment period.
arm group label: Treatment Sequence AB
arm group label: Treatment Sequence BA
intervention type: Drug
intervention name: JNJ-42756493 Capsule
description: Participants will receive 10 mg of JNJ-42756493 capsule as single oral dose on Day 1 of each treatment period.
arm group label: Treatment Sequence AB
arm group label: Treatment Sequence BA
intervention type: Drug
intervention name: JNJ-61818549
description: Participants will JNJ-61818549, 100 microgram (mcg) intravenous infusion over 5 minutes, after 2 hours of administration of JNJ-42756493 tablet/capsule on Day 1 Treatment 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 Trials
role: Study Director
affiliation: Janssen Research & Development, LLC
facility: 
country: Belgium
responsible party type: Sponsor