<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/NCT04426357</url>
  </required_header>
  <id_info>
    <org_study_id>CR108800</org_study_id>
    <secondary_id>2019-004929-25</secondary_id>
    <secondary_id>64417184RSV1008</secondary_id>
    <nct_id>NCT04426357</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Effect of Renal Impairment on JNJ-64417184 and Its Two Minor Metabolites JNJ-68294291 and JNJ-65201526 in Adult Participants</brief_title>
  <official_title>A Single-dose, Open-label, Parallel-group Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-64417184 and Its Two Minor Metabolites JNJ-68294291 and JNJ-65201526 in Adult Participants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Pharmaceutica N.V., Belgium</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Pharmaceutica N.V., Belgium</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to evaluate the pharmacokinetics of JNJ-64417184,&#xD;
      JNJ-68294291, and JNJ-65201526 after a single oral dose of JNJ-64417184 in adult participants&#xD;
      with various degrees of impaired renal function (moderate [optional], severe renal&#xD;
      impairment, and end stage renal disease (ESRD) not requiring hemodialysis) compared to&#xD;
      participants with normal renal function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    company decision&#xD;
  </why_stopped>
  <start_date type="Actual">July 3, 2020</start_date>
  <completion_date type="Actual">November 12, 2020</completion_date>
  <primary_completion_date type="Actual">November 12, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-64417184and its Metabolites (JNJ-68294291 and JNJ-65201526)</measure>
    <time_frame>Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120 and 216 hours post dose</time_frame>
    <description>Cmax is defined as maximum observed plasma analyte concentration of JNJ-64417184 and its metabolites (JNJ-68294291 and JNJ-65201526).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the Plasma Analyte Concentration Time Curve from Time 0 to Time of the Last Measurable Concentration [AUC (0-Last)] of JNJ-64417184 and its Metabolites (JNJ-68294291 and JNJ-65201526)</measure>
    <time_frame>Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120 and 216 hours post dose</time_frame>
    <description>AUC (0-Last) is defined as area under the plasma analyte concentration time curve from time 0 to time of the last measurable (non-below quantification limit [BQL]) concentration of JNJ-64417184 and its metabolites (JNJ-68294291 and JNJ-65201526).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Analyte Concentration Time Curve from Time 0 to Infinite Time [AUC (0-Infinity)] of JNJ-64417184 and its Metabolites (JNJ-68294291 and JNJ-65201526)</measure>
    <time_frame>Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120 and 216 hours post dose</time_frame>
    <description>AUC (0-infinity) is defined as area under the plasma analyte concentration time curve from time 0 to infinite time, calculated as AUC (last) plus C(last)/(lambda)z, where C (last) is the last observed measurable (non-BQL) plasma analyte concentration; extrapolations of more than 20 percent (%) of the total AUC (that is, percent AUC (infinity), extrapolations greater than [&gt;] 20%) are reported as approximations of JNJ-64417184 and its metabolites (JNJ-68294291 and JNJ-65201526).</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 11</time_frame>
    <description>An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Renal Impairment</condition>
  <arm_group>
    <arm_group_label>Group 1 (Participants with Renal impairment): JNJ-64417184</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with varying degrees of impaired renal impairment function (moderate renal impairment [optional], severe renal impairment, and end stage renal disease [ESRD] not requiring hemodialysis) will be enrolled and will receive a single oral dose of JNJ-64417184 as film coated tablet on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 (Healthy Participants): Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants with normal renal function will be enrolled in controlled group and will receive a single oral dose of JNJ-64417184 as film coated tablet on Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-64417184</intervention_name>
    <description>Participants will receive single oral (as film coated tablet) dose of JNJ-64417184 on Day 1.</description>
    <arm_group_label>Group 1 (Participants with Renal impairment): JNJ-64417184</arm_group_label>
    <arm_group_label>Group 2 (Healthy Participants): Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with normal renal function:&#xD;
&#xD;
        must have normal renal function defined as: estimated glomerular filtration rate (eGFR)&#xD;
        greater than or equal to (&gt;=) 90 milliliter per minute per 1.73 meter square (mL/min/1.73&#xD;
        m^2 (calculated by the modification of diet in renal disease [MDRD] formula)&#xD;
&#xD;
          -  Healthy on the basis of physical examination, medical and surgical history, and vital&#xD;
             signs performed at screening. If there are abnormalities, the participant may be&#xD;
             included only if the investigator judges the abnormalities to be not clinically&#xD;
             significant or to be appropriate and reasonable for the population under study. This&#xD;
             determination must be recorded in the participant's source documents and initialed by&#xD;
             the investigator&#xD;
&#xD;
          -  Participants with moderate or severe renal impairment:&#xD;
&#xD;
        must meet the following additional inclusion criteria to be enrolled in the study: must be&#xD;
        otherwise healthy except for the renal impairment and its underlying disease states and&#xD;
        mild comorbidities and participant must be medically stable on the basis of physical&#xD;
        examination, medical history, vital signs, 12-lead Electrocardiogram (ECG), and clinical&#xD;
        laboratory tests performed at screening. If there are abnormalities or results outside the&#xD;
        normal reference ranges, the participant may be included only if the investigator judges&#xD;
        the abnormalities or deviations from normal to be not clinically significant or to be&#xD;
        appropriate and reasonable for the population under study. This determination must be&#xD;
        recorded in the participant's source documents and initialed by the investigator&#xD;
&#xD;
          -  Participants with end stage renal disease (ESRD): must have a hematocrit at screening&#xD;
             of greater than or equal to (&gt;=) 30 percent (%)&#xD;
&#xD;
          -  Must not smoke more than 10 cigarettes or 2 cigars or 2 pipes per day from within 3&#xD;
             months prior to screening until the end of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of any illness (unrelated to renal impairment or its underlying disease, as&#xD;
             appropriate) that, in the opinion of the investigator, might confound the results of&#xD;
             the study or pose an additional risk in administering study drug to the participant.&#xD;
             This may include but is not limited to history of relevant drug or food allergies,&#xD;
             history of cardiovascular or central nervous system disease, history or presence of&#xD;
             clinically significant pathology, chronic skin disease, or history of mental disease&#xD;
&#xD;
          -  Known allergies, hypersensitivity, or intolerance to JNJ-64417184 or any of its&#xD;
             excipients&#xD;
&#xD;
          -  Past history of clinically significant cardiac arrhythmias (example, extrasystole,&#xD;
             tachycardia at rest), history of risk factors for Torsade de Pointes syndrome&#xD;
             (example, hypokalemia, family history of long QT Syndrome)&#xD;
&#xD;
          -  Any evidence of clinically significant heart block or bundle branch block at screening&#xD;
&#xD;
          -  Current human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection (confirmed by&#xD;
             antibodies) at screening&#xD;
&#xD;
          -  History of hepatitis A, B, or C infection, or current hepatitis A infection (confirmed&#xD;
             by hepatitis A antibody immunoglobulin M [IgM]), or hepatitis B virus (HBV) infection&#xD;
             (confirmed by hepatitis B surface antigen), or hepatitis C virus (HCV) infection&#xD;
             (confirmed by HCV antibody) at screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Pharmaceutica N.V., Belgium Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Pharmaceutica N.V., Belgium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CRS Clinical Research Services Kiel GmbH</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APEX GmbH</name>
      <address>
        <city>Munchen</city>
        <zip>81241</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>January 13, 2021</last_update_submitted>
  <last_update_submitted_qc>January 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2021</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>Renal Insufficiency</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.&#xD;
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/NCT04426357
org study id: CR108800
secondary id: 2019-004929-25
secondary id: 64417184RSV1008
nct id: NCT04426357
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main purpose of this study is to evaluate the pharmacokinetics of JNJ-64417184,
      JNJ-68294291, and JNJ-65201526 after a single oral dose of JNJ-64417184 in adult participants
      with various degrees of impaired renal function (moderate [optional], severe renal
      impairment, and end stage renal disease (ESRD) not requiring hemodialysis) compared to
      participants with normal renal function.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-64417184and its Metabolites (JNJ-68294291 and JNJ-65201526)
time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120 and 216 hours post dose
description: Cmax is defined as maximum observed plasma analyte concentration of JNJ-64417184 and its metabolites (JNJ-68294291 and JNJ-65201526).
measure: Area under the Plasma Analyte Concentration Time Curve from Time 0 to Time of the Last Measurable Concentration [AUC (0-Last)] of JNJ-64417184 and its Metabolites (JNJ-68294291 and JNJ-65201526)
time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120 and 216 hours post dose
description: AUC (0-Last) is defined as area under the plasma analyte concentration time curve from time 0 to time of the last measurable (non-below quantification limit [BQL]) concentration of JNJ-64417184 and its metabolites (JNJ-68294291 and JNJ-65201526).
measure: Area Under the Plasma Analyte Concentration Time Curve from Time 0 to Infinite Time [AUC (0-Infinity)] of JNJ-64417184 and its Metabolites (JNJ-68294291 and JNJ-65201526)
time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120 and 216 hours post dose
description: AUC (0-infinity) is defined as area under the plasma analyte concentration time curve from time 0 to infinite time, calculated as AUC (last) plus C(last)/(lambda)z, where C (last) is the last observed measurable (non-BQL) plasma analyte concentration; extrapolations of more than 20 percent (%) of the total AUC (that is, percent AUC (infinity), extrapolations greater than [>] 20%) are reported as approximations of JNJ-64417184 and its metabolites (JNJ-68294291 and JNJ-65201526).
measure: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
time frame: Up to Day 11
description: An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
arm group label: Group 1 (Participants with Renal impairment): JNJ-64417184
arm group type: Experimental
description: Participants with varying degrees of impaired renal impairment function (moderate renal impairment [optional], severe renal impairment, and end stage renal disease [ESRD] not requiring hemodialysis) will be enrolled and will receive a single oral dose of JNJ-64417184 as film coated tablet on Day 1.
arm group label: Group 2 (Healthy Participants): Control Group
arm group type: Active Comparator
description: Participants with normal renal function will be enrolled in controlled group and will receive a single oral dose of JNJ-64417184 as film coated tablet on Day 1.
intervention type: Drug
intervention name: JNJ-64417184
description: Participants will receive single oral (as film coated tablet) dose of JNJ-64417184 on Day 1.
arm group label: Group 1 (Participants with Renal impairment): JNJ-64417184
arm group label: Group 2 (Healthy Participants): Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janssen Pharmaceutica N.V., Belgium Clinical Trial
role: Study Director
affiliation: Janssen Pharmaceutica N.V., Belgium
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Renal Insufficiency
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