<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/NCT04474210</url>
  </required_header>
  <id_info>
    <org_study_id>CR108802</org_study_id>
    <secondary_id>56136379HPB1010</secondary_id>
    <nct_id>NCT04474210</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Effect of Renal Impairment on JNJ-56136379 in Adult Participants</brief_title>
  <official_title>An Open-Label, Single-Dose Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-56136379 in 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>No</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 evaluate the pharmacokinetics (PK) of a single oral dose of&#xD;
      JNJ-56136379 in adult participants with renal impairment compared with healthy participants&#xD;
      with normal renal function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Strategic Decision&#xD;
  </why_stopped>
  <start_date type="Actual">August 19, 2020</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 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)</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>Cmax is defined as the maximum observed plasma analyte concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Reach the Maximum Observed Plasma Analyte Concentration (Tmax)</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>Tmax is defined as the actual sampling time to reach the maximum observed plasma analyte concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Analyte Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC [0-24])</measure>
    <time_frame>Up to 24 hours postdose</time_frame>
    <description>AUC (0-24) is defined as area under the analyte concentration-time curve (AUC) from time 0 to 24 hours postdose, calculated by linear-linear trapezoidal summation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Analyte Concentration-time Curve From Time Zero to 144 Hours Postdose (AUC [0-144])</measure>
    <time_frame>Up to 144 hours postdose</time_frame>
    <description>AUC (0-144) is defined as AUC from time 0 to 144 hours postdose, calculated by linear-linear trapezoidal summation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Analyte Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC [0-last])</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>AUC (0-last) is defined as AUC from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Analyte Concentration-time Curve From Time Zero to Infinity (AUC [0-infinity])</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>AUC (0-infinity) is defined as AUC from time 0 to infinity, calculated as the sum of AUC (0-last) and C(last)/lambda(z); where C(last) is the last observed measurable (non-BQL) concentration; and lambda(z) is apparent terminal elimination rate constant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Apparent Oral Clearance (CL/F)</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>CL/F is defined as total apparent oral clearance, calculated as dose/AUC (0-infinity).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Volume of Distribution (Vd/F)</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>Vd/F is defined as apparent volume of distribution, calculated as dose/[lambda (z)*AUC (0-infinity)].</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Terminal Elimination Rate Constant (Lambda[z])</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>Lambda(z) is defined as apparent terminal elimination rate constant, estimated by linear regression using the terminal log-linear phase of the log-transformed concentration vs time curve.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Terminal Elimination Half-life (t1/2)</measure>
    <time_frame>Up to Day 29</time_frame>
    <description>t1/2 is defined as apparent terminal elimination half-life, calculated as 0.693/lambda(z).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of JNJ-56136379 Excreted in Urine (Ae,%Dose)</measure>
    <time_frame>Up to Day 7</time_frame>
    <description>Ae,%Dose is defined as cumulative urinary recovery represented as a percentage of dose, calculated as 100*(Aetotal/Dose).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Renal Clearance (CLr)</measure>
    <time_frame>Up to 144 hours postdose</time_frame>
    <description>CLr is defined as renal clearance, calculated as Ae(0-144h)/AUC(144h).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>Up to 8 weeks</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>5</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Renal Insufficiency</condition>
  <arm_group>
    <arm_group_label>Part A: Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with severe renal impairment and/or kidney failure (estimated glomerular filtration rate [eGFR] less than [&lt;] 30 milliliter[mL]/minute but not yet on hemodialysis) will receive a single oral dose of JNJ-56136379.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A: Group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy participants with normal renal function (eGFR greater than or equal to [&gt;=] 90 mL/minute), will receive a single oral dose of JNJ-56136379.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: Group 3 (Optional)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with mild renal impairment (eGFR: 60 to 89 mL/minute) will receive a single oral dose of JNJ-56136379.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: Group 4 (Optional)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with moderate renal impairment (eGFR: 30 to 59 mL/minute) will receive a single oral dose of JNJ-56136379.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: Group 5 (Optional)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with kidney failure (eGFR: &lt;15 mL/minute and on hemodialysis; pharmacokinetic [PK] to be evaluated during non-dialysis days) will receive a single oral dose of JNJ-56136379.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-56136379</intervention_name>
    <description>Participants will receive JNJ-56136379 tablets orally.</description>
    <arm_group_label>Part A: Group 1</arm_group_label>
    <arm_group_label>Part A: Group 2</arm_group_label>
    <arm_group_label>Part B: Group 3 (Optional)</arm_group_label>
    <arm_group_label>Part B: Group 4 (Optional)</arm_group_label>
    <arm_group_label>Part B: Group 5 (Optional)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Body mass index (BMI) (kilograms [kg]/height [m]^2) between 18.0 and 38.0&#xD;
        kilogram/meter^2 (kg/m2) (inclusive), and body weight not less than (&lt;) 50 kg&#xD;
&#xD;
        Participants with normal renal function:&#xD;
&#xD;
          -  Have normal renal function defined as estimated glomerular filtration rate (eGFR)&#xD;
             greater than or equal to (&gt;=) 90 milliliter/minute computed with the online calculator&#xD;
             on the CKD-EPI website by use of the Chronic Kidney Disease Epidemiology Collaboration&#xD;
             creatinine clearance (CKD-EPIcr) result&#xD;
&#xD;
          -  Must have stable renal function as defined as: (a) for participants with impaired&#xD;
             renal function: &lt;20 percent (%) change in serum creatinine concentrations between&#xD;
             screening and Day -1; (b) for healthy participants: a change in serum creatinine&#xD;
             concentration &lt;0.2 milligram per deciliter (mg/dL) between screening and Day -1&#xD;
&#xD;
        Participants with renal impairment:&#xD;
&#xD;
          -  Have an impaired renal function based on eGFR as(eGFR computed with the online&#xD;
             calculator on the CKD-EPI website providing eGFR (in mL/min units) by use of the&#xD;
             CKD-EPIcr result: (a) eGFR &lt;90 to 60 mL/minute for participants in Group 3 (mild renal&#xD;
             impairment cohort); (b) eGFR 30 to 59 mL/minute for participants in Group 4 (moderate&#xD;
             renal impairment cohort); (c) eGFR &lt;30 mL/minute but not yet on hemodialysis, for&#xD;
             participants in Group 1 (severe renal impairment and/or kidney failure); (d) eGFR &lt;15&#xD;
             mL/minute and on hemodialysis, for participants in Group 5 (kidney failure)&#xD;
&#xD;
          -  Concomitant medications to treat underlying disease states or medical conditions&#xD;
             related to renal impairment are allowed. Participants must be on a stable dose of&#xD;
             medication and/or treatment regimen for at least 2 months (3 months for thyroid&#xD;
             hormone replacement therapy [HRT]) before dosing as well as during the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Individuals who take creatine supplements, have a non-standard muscle mass such as&#xD;
        amputation, malnutrition, or muscle wasting; because these factors are not accounted for in&#xD;
        the prediction equations for GFR chronic kidney disease epidemiology collaboration (CKD&#xD;
        EPI)&#xD;
&#xD;
        Participants with normal renal function:&#xD;
&#xD;
          -  Clinically significant abnormal values for hematology, clinical chemistry, or&#xD;
             urinalysis at screening or Day -1, as deemed appropriate by the investigator&#xD;
&#xD;
          -  Clinically significant abnormal physical examination, vital signs, body temperature,&#xD;
             or 12 lead ECG at screening or Day -1, as deemed appropriate by the investigator&#xD;
&#xD;
        Participants with renal impairment:&#xD;
&#xD;
          -  Evidence of clinically apparent concurrent disease based upon complete clinical&#xD;
             laboratory testing, full physical examination, or medical history, except for&#xD;
             controlled hypertension and those problems directly associated with the primary&#xD;
             diagnosis of renal impairment&#xD;
&#xD;
          -  Any clinically significant laboratory abnormality except abnormalities that may be&#xD;
             caused by renal impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 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>Orlando Clinical Research Center</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Texas Liver Institute</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>July 19, 2021</last_update_submitted>
  <last_update_submitted_qc>July 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Renal Impairment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>JNJ-56136379</mesh_term>
  </intervention_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/NCT04474210
org study id: CR108802
secondary id: 56136379HPB1010
nct id: NCT04474210
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of
      JNJ-56136379 in adult participants with renal impairment compared with healthy 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)
time frame: Up to Day 29
description: Cmax is defined as the maximum observed plasma analyte concentration.
measure: Time to Reach the Maximum Observed Plasma Analyte Concentration (Tmax)
time frame: Up to Day 29
description: Tmax is defined as the actual sampling time to reach the maximum observed plasma analyte concentration.
measure: Area Under the Analyte Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC [0-24])
time frame: Up to 24 hours postdose
description: AUC (0-24) is defined as area under the analyte concentration-time curve (AUC) from time 0 to 24 hours postdose, calculated by linear-linear trapezoidal summation.
measure: Area Under the Analyte Concentration-time Curve From Time Zero to 144 Hours Postdose (AUC [0-144])
time frame: Up to 144 hours postdose
description: AUC (0-144) is defined as AUC from time 0 to 144 hours postdose, calculated by linear-linear trapezoidal summation.
measure: Area Under the Analyte Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC [0-last])
time frame: Up to Day 29
description: AUC (0-last) is defined as AUC from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation.
measure: Area Under the Analyte Concentration-time Curve From Time Zero to Infinity (AUC [0-infinity])
time frame: Up to Day 29
description: AUC (0-infinity) is defined as AUC from time 0 to infinity, calculated as the sum of AUC (0-last) and C(last)/lambda(z); where C(last) is the last observed measurable (non-BQL) concentration; and lambda(z) is apparent terminal elimination rate constant.
measure: Total Apparent Oral Clearance (CL/F)
time frame: Up to Day 29
description: CL/F is defined as total apparent oral clearance, calculated as dose/AUC (0-infinity).
measure: Apparent Volume of Distribution (Vd/F)
time frame: Up to Day 29
description: Vd/F is defined as apparent volume of distribution, calculated as dose/[lambda (z)*AUC (0-infinity)].
measure: Apparent Terminal Elimination Rate Constant (Lambda[z])
time frame: Up to Day 29
description: Lambda(z) is defined as apparent terminal elimination rate constant, estimated by linear regression using the terminal log-linear phase of the log-transformed concentration vs time curve.
measure: Apparent Terminal Elimination Half-life (t1/2)
time frame: Up to Day 29
description: t1/2 is defined as apparent terminal elimination half-life, calculated as 0.693/lambda(z).
measure: Percentage of JNJ-56136379 Excreted in Urine (Ae,%Dose)
time frame: Up to Day 7
description: Ae,%Dose is defined as cumulative urinary recovery represented as a percentage of dose, calculated as 100*(Aetotal/Dose).
measure: Renal Clearance (CLr)
time frame: Up to 144 hours postdose
description: CLr is defined as renal clearance, calculated as Ae(0-144h)/AUC(144h).
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: Up to 8 weeks
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: Part A: Group 1
arm group type: Experimental
description: Participants with severe renal impairment and/or kidney failure (estimated glomerular filtration rate [eGFR] less than [<] 30 milliliter[mL]/minute but not yet on hemodialysis) will receive a single oral dose of JNJ-56136379.
arm group label: Part A: Group 2
arm group type: Active Comparator
description: Healthy participants with normal renal function (eGFR greater than or equal to [>=] 90 mL/minute), will receive a single oral dose of JNJ-56136379.
arm group label: Part B: Group 3 (Optional)
arm group type: Experimental
description: Participants with mild renal impairment (eGFR: 60 to 89 mL/minute) will receive a single oral dose of JNJ-56136379.
arm group label: Part B: Group 4 (Optional)
arm group type: Experimental
description: Participants with moderate renal impairment (eGFR: 30 to 59 mL/minute) will receive a single oral dose of JNJ-56136379.
arm group label: Part B: Group 5 (Optional)
arm group type: Experimental
description: Participants with kidney failure (eGFR: <15 mL/minute and on hemodialysis; pharmacokinetic [PK] to be evaluated during non-dialysis days) will receive a single oral dose of JNJ-56136379.
intervention type: Drug
intervention name: JNJ-56136379
description: Participants will receive JNJ-56136379 tablets orally.
arm group label: Part A: Group 1
arm group label: Part A: Group 2
arm group label: Part B: Group 3 (Optional)
arm group label: Part B: Group 4 (Optional)
arm group label: Part B: Group 5 (Optional)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 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 States
responsible party type: Sponsor
mesh term: Renal Insufficiency
mesh term: JNJ-56136379
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