<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/NCT01690286</url>
  </required_header>
  <id_info>
    <org_study_id>CR100915</org_study_id>
    <secondary_id>38518168ARA1003</secondary_id>
    <nct_id>NCT01690286</nct_id>
  </id_info>
  <brief_title>Effect of Ketoconazole on the Pharmacokinetics of JNJ-38518168 in Healthy Volunteers</brief_title>
  <official_title>An Open-Label Study to Assess the Effects of Repeated Twice-Daily Doses of Ketoconazole on the Steady-State Pharmacokinetics of JNJ-38518168 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>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effects of repeated twice-daily administration&#xD;
      of 200 mg ketoconazole on the steady-state pharmacokinetics of JNJ-38518168.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label (all people know the identity of the intervention), single-sequence,&#xD;
      randomized (dose of JNJ-38518168 (3 mg or 30 mg) is assigned by chance), single-center,&#xD;
      multiple-dose study designed to assess the potential effects of multiple oral administration&#xD;
      of ketoconazole (KTZ) on the steady-state (a situation where the overall intake of a drug is&#xD;
      in equilibrium with its elimination) pharmacokinetics of JNJ-38518168. Pharmacokinetics (PK)&#xD;
      explores how the drug is absorbed in the body, distributed within the body, and how it is&#xD;
      removed from the body over time. The study consists of 3 phases: a Screening Phase of&#xD;
      approximately 3 weeks (Days -22 to -2); an Open-Label Phase (Days -1 to 26); and a Follow-up&#xD;
      Phase occurring from 7 to 10 days after the last dose of study drug. Participants will be&#xD;
      randomly assigned to receive either a daily dose of 3 mg JNJ-38518168 (Group 1) or a daily&#xD;
      dose of 30 mg JNJ-38518168 (Group 2) orally administered for 25 days. All participants will&#xD;
      receive multiple oral doses of KTZ (200 mg every 12 hours for both Groups 1 and 2) from Day&#xD;
      22 through Day 25. An optional group of participants receiving 10 mg once daily of&#xD;
      JNJ-38518168 (Group 3) may be evaluated if the data from Groups 1 and 2 do not allow the&#xD;
      sponsor to estimate sufficiently the interaction between KTZ and daily dose of 10 mg&#xD;
      JNJ-38518168. The participants will receive an oral dose of the study drugs in the morning of&#xD;
      specified days, after an overnight fast for at least 10 hours. Blood samples will be&#xD;
      collected at various times throughout the study for evaluation of drug concentrations in&#xD;
      plasma. Safety will be assessed by reporting of adverse events, vital signs, physical&#xD;
      examination results, weight, and electrocardiogram (ECG) evaluations. Participants will leave&#xD;
      the study center on Day 26 after the collection of the last scheduled PK blood sample. For&#xD;
      each participant, a follow-up visit will occur 7 to 10 days after the last dose of study&#xD;
      drug. For each participant, the total duration of the study is approximately 8 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The plasma concentrations of JNJ-38518168</measure>
    <time_frame>From Day 13 up to Day 26</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The plasma concentrations of ketoconazole</measure>
    <time_frame>Day 25</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The time to attain steady-state pharmacokinetics following JNJ-38518168 once daily doses for 21 consecutive days</measure>
    <time_frame>21 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Group 1: JNJ-38518168 3 mg/ ketoconazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: JNJ-38518168 30 mg/ ketoconazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3: JNJ-38518168 10 mg/ ketoconazole (optional)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-38518168 3 mg</intervention_name>
    <description>One oral daily dose of JNJ-38518168 3 mg for 25 days.</description>
    <arm_group_label>Group 1: JNJ-38518168 3 mg/ ketoconazole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-38518168 30 mg</intervention_name>
    <description>One oral daily dose of JNJ-38518168 30 mg for 25 days.</description>
    <arm_group_label>Group 2: JNJ-38518168 30 mg/ ketoconazole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-38518168 10 mg</intervention_name>
    <description>One oral daily dose of JNJ-38518168 10 mg for 25 days.</description>
    <arm_group_label>Group 3: JNJ-38518168 10 mg/ ketoconazole (optional)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketoconazole 200 mg</intervention_name>
    <description>Oral doses of ketoconazole 200 mg every 12 hours, from Day 22 through Day 25.</description>
    <arm_group_label>Group 1: JNJ-38518168 3 mg/ ketoconazole</arm_group_label>
    <arm_group_label>Group 2: JNJ-38518168 30 mg/ ketoconazole</arm_group_label>
    <arm_group_label>Group 3: JNJ-38518168 10 mg/ ketoconazole (optional)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent document indicating that the participant understands the&#xD;
             purpose of and procedures required for the study and is willing to participate in the&#xD;
             study&#xD;
&#xD;
          -  If a woman, must be postmenopausal, surgically sterile, abstinent, or, if sexually&#xD;
             active, be practicing an effective method of birth control before, throughout, and for&#xD;
             3 months after the study&#xD;
&#xD;
          -  If a man, must agree to use an adequate contraception method, or partner using&#xD;
             effective contraception, and to not donate sperm during the study and for 3 months&#xD;
             after the study&#xD;
&#xD;
          -  Body mass index (BMI; weight [kg]/height2 [m]2) between 18 and 30 kg/m2 (inclusive),&#xD;
             and body weight not less than 50 kg&#xD;
&#xD;
          -  Blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg&#xD;
             diastolic&#xD;
&#xD;
          -  Non-smoker&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of or current clinically significant medical illness, condition or disease&#xD;
             that the investigator considers should exclude the participant or that could interfere&#xD;
             with the interpretation of the study results&#xD;
&#xD;
          -  Clinically significant abnormal lab results at screening or at admission to the study&#xD;
             center&#xD;
&#xD;
          -  Clinically significant abnormal physical examination or electrocardiogram (ECG) at&#xD;
             screening or at admission to the study center&#xD;
&#xD;
          -  Use of any prescription or nonprescription medication (including vitamins and herbal&#xD;
             supplements), except for acetaminophen and oral contraceptives and hormonal&#xD;
             replacement therapy within 14 days before the first dose of study drug is scheduled&#xD;
&#xD;
          -  Has a history of malignancy (the tendency of a medical condition, especially tumors,&#xD;
             to become progressively worse) within the previous 5 years before screening (certain&#xD;
             less serious malignancies during the previous 5 years, such as basal cell carcinoma of&#xD;
             the skin which has been adequately treated, may be allowed by the study doctor)&#xD;
&#xD;
          -  Donated blood or had a substantial loss of blood within 3 months before first&#xD;
             administration of study drug&#xD;
&#xD;
          -  Pregnant or currently breast-feeding&#xD;
&#xD;
          -  Smoking or using nicotine-containing products within 3 months of 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>Neptune</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>July 15, 2013</last_update_submitted>
  <last_update_submitted_qc>July 15, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy</keyword>
  <keyword>Ketoconazole</keyword>
  <keyword>JNJ-38518168</keyword>
  <keyword>Pharmacokinetics</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketoconazole</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01690286
org study id: CR100915
secondary id: 38518168ARA1003
nct id: NCT01690286
lead sponsor: 
The purpose of this study is to evaluate the effects of repeated twice-daily administration
      of 200 mg ketoconazole on the steady-state pharmacokinetics of JNJ-38518168.
This is an open-label (all people know the identity of the intervention), single-sequence,
      randomized (dose of JNJ-38518168 (3 mg or 30 mg) is assigned by chance), single-center,
      multiple-dose study designed to assess the potential effects of multiple oral administration
      of ketoconazole (KTZ) on the steady-state (a situation where the overall intake of a drug is
      in equilibrium with its elimination) pharmacokinetics of JNJ-38518168. Pharmacokinetics (PK)
      explores how the drug is absorbed in the body, distributed within the body, and how it is
      removed from the body over time. The study consists of 3 phases: a Screening Phase of
      approximately 3 weeks (Days -22 to -2); an Open-Label Phase (Days -1 to 26); and a Follow-up
      Phase occurring from 7 to 10 days after the last dose of study drug. Participants will be
      randomly assigned to receive either a daily dose of 3 mg JNJ-38518168 (Group 1) or a daily
      dose of 30 mg JNJ-38518168 (Group 2) orally administered for 25 days. All participants will
      receive multiple oral doses of KTZ (200 mg every 12 hours for both Groups 1 and 2) from Day
      22 through Day 25. An optional group of participants receiving 10 mg once daily of
      JNJ-38518168 (Group 3) may be evaluated if the data from Groups 1 and 2 do not allow the
      sponsor to estimate sufficiently the interaction between KTZ and daily dose of 10 mg
      JNJ-38518168. The participants will receive an oral dose of the study drugs in the morning of
      specified days, after an overnight fast for at least 10 hours. Blood samples will be
      collected at various times throughout the study for evaluation of drug concentrations in
      plasma. Safety will be assessed by reporting of adverse events, vital signs, physical
      examination results, weight, and electrocardiogram (ECG) evaluations. Participants will leave
      the study center on Day 26 after the collection of the last scheduled PK blood sample. For
      each participant, a follow-up visit will occur 7 to 10 days after the last dose of study
      drug. For each participant, the total duration of the study is approximately 8 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The plasma concentrations of JNJ-38518168
time frame: From Day 13 up to Day 26
measure: The plasma concentrations of ketoconazole
time frame: Day 25
measure: The time to attain steady-state pharmacokinetics following JNJ-38518168 once daily doses for 21 consecutive days
time frame: 21 days
arm group label: Group 1: JNJ-38518168 3 mg/ ketoconazole
arm group type: Experimental
arm group label: Group 2: JNJ-38518168 30 mg/ ketoconazole
arm group type: Experimental
arm group label: Group 3: JNJ-38518168 10 mg/ ketoconazole (optional)
arm group type: Experimental
intervention type: Drug
intervention name: JNJ-38518168 3 mg
description: One oral daily dose of JNJ-38518168 3 mg for 25 days.
arm group label: Group 1: JNJ-38518168 3 mg/ ketoconazole
intervention type: Drug
intervention name: JNJ-38518168 30 mg
description: One oral daily dose of JNJ-38518168 30 mg for 25 days.
arm group label: Group 2: JNJ-38518168 30 mg/ ketoconazole
intervention type: Drug
intervention name: JNJ-38518168 10 mg
description: One oral daily dose of JNJ-38518168 10 mg for 25 days.
arm group label: Group 3: JNJ-38518168 10 mg/ ketoconazole (optional)
intervention type: Drug
intervention name: Ketoconazole 200 mg
description: Oral doses of ketoconazole 200 mg every 12 hours, from Day 22 through Day 25.
arm group label: Group 1: JNJ-38518168 3 mg/ ketoconazole
arm group label: Group 2: JNJ-38518168 30 mg/ ketoconazole
arm group label: Group 3: JNJ-38518168 10 mg/ ketoconazole (optional)
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: United States
responsible party type: Sponsor
mesh term: Ketoconazole