<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/NCT03816631</url>
  </required_header>
  <id_info>
    <org_study_id>CR108571</org_study_id>
    <secondary_id>2018-002817-36</secondary_id>
    <secondary_id>63623872FLZ1013</secondary_id>
    <nct_id>NCT03816631</nct_id>
  </id_info>
  <brief_title>A Study of Orally Administered Pimodivir in Adult Participants With Hepatic Impairment</brief_title>
  <official_title>A Phase 1, Open-label, Single-dose Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Orally Administered Pimodivir in Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen-Cilag International NV</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen-Cilag International NV</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 purpose is to evaluate the pharmacokinetics (PK) of a single oral dose of 600 milligram&#xD;
      (mg) pimodivir in adult participants with impaired hepatic function compared to adult&#xD;
      participants with normal hepatic function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 28, 2019</start_date>
  <completion_date type="Actual">April 27, 2020</completion_date>
  <primary_completion_date type="Actual">April 27, 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 Analyte Concentration (Cmax) of Pimodivir</measure>
    <time_frame>Predose, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 120 hours post dose and end of study (up to Day 14)</time_frame>
    <description>Cmax is defined as maximum observed analyte concentration of pimodivir.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under Concentration-Time Curve from Time 0 to the Time of the Last Concentration (AUC[last]) of Pimodivir</measure>
    <time_frame>Predose, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 120 hours post dose and end of study (up to Day 14)</time_frame>
    <description>AUC(last) is defined as the time 0 to the time of the last measurable (non-below quantification limit) concentration of Pimodivir calculated by linear-linear trapezoidal summation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under Concentration-Time Curve from Time 0 to Infinite Time (AUC[0-infinity]) of Pimodivir</measure>
    <time_frame>Predose, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 120 hours post dose and end of study (up to Day 14)</time_frame>
    <description>The AUC ([0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C (last)/ lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to the time of the last measurable concentration, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Event as a Measure of Safety and Tolerability</measure>
    <time_frame>Approximately 42 days</time_frame>
    <description>An adverse event 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>4</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Hepatic Impairment</condition>
  <arm_group>
    <arm_group_label>Part A: Group 1: Severe hepatic function</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with severe hepatic function will receive single oral dose of pimodivir 600 milligram (mg) (2*300 mg tablet) under fasted condition on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A and B: Group 2: Normal hepatic function</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with normal hepatic function will receive single oral dose of pimodivir 600 mg (2*300 mg tablet) under fasted condition on Day 1. The recruitment in Part B will be started based on assessment by Sponsor upon evaluation of partial data obtained in Part A.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: Group 3: Moderate hepatic function</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with moderate hepatic function will receive single oral dose of pimodivir 600 mg (2*300 mg tablet) under fasted condition on Day 1. The recruitment in Part B will be started based on assessment by Sponsor upon evaluation of partial data obtained in Part A.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: Group 4: Mild hepatic function</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with mild hepatic function will receive single oral dose of Pimodivir 600 mg (2*300 mg tablet) under fasted condition on Day 1. The recruitment in Part B will be started based on assessment by Sponsor upon evaluation of partial data obtained in Part A.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pimodivir</intervention_name>
    <description>Participants will receive single oral dose of Pimodivir 600 mg (2*300 mg tablets) under fasted condition on Day 1.</description>
    <arm_group_label>Part A and B: Group 2: Normal hepatic function</arm_group_label>
    <arm_group_label>Part A: Group 1: Severe hepatic function</arm_group_label>
    <arm_group_label>Part B: Group 3: Moderate hepatic function</arm_group_label>
    <arm_group_label>Part B: Group 4: Mild hepatic function</arm_group_label>
    <other_name>JNJ-63623872</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant must have a stable hepatic function as confirmed by albumin levels,&#xD;
             prothrombin time (PT), International Normalized Ratio (INR), and platelet count&#xD;
             measured during screening and those measured within 24 hours prior to study drug&#xD;
             administration. Participants with a Transjugular Intrahepatic Portosystemic Shunt&#xD;
             procedure will be allowed to participate in the study&#xD;
&#xD;
          -  Participant must have a body mass index (BMI; weight [Kilogram {kg}/height^2 [meter&#xD;
             {m}^2]) between 18.0 and 38.0 kg/m^2, extremes included, and body weight not less than&#xD;
             50 kg at screening&#xD;
&#xD;
          -  Participant must have a 12-lead electrocardiogram (ECG) consistent with normal cardiac&#xD;
             conduction and function at screening, including: (a) Sinus rhythm; (b) Pulse rate&#xD;
             between 45 and 100 beats per minute (bpm); (c) QT interval corrected for heart rate&#xD;
             (QTc) according to Fridericia formula (QTcF) less than or equal to (&lt;=) 450&#xD;
             millisecond (ms) for male participant and &lt;= 470 ms for female participant; (d) QRS&#xD;
             interval of less than (&lt;) 120 ms; (e) PR interval &lt;= 220 ms and (f) Electrocardiogram&#xD;
             morphology consistent with healthy cardiac conduction and function. Participant with&#xD;
             pacemaker is eligible as long as all criteria mentioned above are met&#xD;
&#xD;
          -  A woman, except if postmenopausal, must have a negative highly sensitive serum&#xD;
             pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and a&#xD;
             negative urine pregnancy test on Day -1&#xD;
&#xD;
          -  Contraceptive use by men or women should be consistent with local regulations&#xD;
             regarding the use of contraceptive methods for participants participating in clinical&#xD;
             studies&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant has known allergies, hypersensitivity, or intolerance to pimodivir or its&#xD;
             excipients&#xD;
&#xD;
          -  Participant has donated blood or blood products or had substantial loss of blood (more&#xD;
             than 500 milliliter [mL]) within 3 months before administration of the study drug or&#xD;
             intention to donate blood or blood products during the study&#xD;
&#xD;
          -  Participant has received an experimental drug (including investigational vaccines) or&#xD;
             used an experimental medical device within 1 month or within a period less than 10&#xD;
             times the drug's half-life, whichever is longer, before administration of the study&#xD;
             drug is scheduled&#xD;
&#xD;
          -  Participant has preplanned surgery or procedures that would interfere with the conduct&#xD;
             of the study&#xD;
&#xD;
          -  Participant is a woman who is pregnant, breast-feeding, or planning to become pregnant&#xD;
             while enrolled in this study or a woman of childbearing potential who is unwilling to&#xD;
             use an acceptable method of contraception&#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-Cilag International NV Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen-Cilag International NV</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>July 2020</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</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>Liver Diseases</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/NCT03816631
org study id: CR108571
secondary id: 2018-002817-36
secondary id: 63623872FLZ1013
nct id: NCT03816631
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose is to evaluate the pharmacokinetics (PK) of a single oral dose of 600 milligram
      (mg) pimodivir in adult participants with impaired hepatic function compared to adult
      participants with normal hepatic function.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Maximum Observed Analyte Concentration (Cmax) of Pimodivir
time frame: Predose, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 120 hours post dose and end of study (up to Day 14)
description: Cmax is defined as maximum observed analyte concentration of pimodivir.
measure: Area Under Concentration-Time Curve from Time 0 to the Time of the Last Concentration (AUC[last]) of Pimodivir
time frame: Predose, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 120 hours post dose and end of study (up to Day 14)
description: AUC(last) is defined as the time 0 to the time of the last measurable (non-below quantification limit) concentration of Pimodivir calculated by linear-linear trapezoidal summation.
measure: Area Under Concentration-Time Curve from Time 0 to Infinite Time (AUC[0-infinity]) of Pimodivir
time frame: Predose, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 120 hours post dose and end of study (up to Day 14)
description: The AUC ([0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C (last)/ lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to the time of the last measurable concentration, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
measure: Number of Participants with Adverse Event as a Measure of Safety and Tolerability
time frame: Approximately 42 days
description: An adverse event 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: Severe hepatic function
arm group type: Experimental
description: Participants with severe hepatic function will receive single oral dose of pimodivir 600 milligram (mg) (2*300 mg tablet) under fasted condition on Day 1.
arm group label: Part A and B: Group 2: Normal hepatic function
arm group type: Experimental
description: Participants with normal hepatic function will receive single oral dose of pimodivir 600 mg (2*300 mg tablet) under fasted condition on Day 1. The recruitment in Part B will be started based on assessment by Sponsor upon evaluation of partial data obtained in Part A.
arm group label: Part B: Group 3: Moderate hepatic function
arm group type: Experimental
description: Participants with moderate hepatic function will receive single oral dose of pimodivir 600 mg (2*300 mg tablet) under fasted condition on Day 1. The recruitment in Part B will be started based on assessment by Sponsor upon evaluation of partial data obtained in Part A.
arm group label: Part B: Group 4: Mild hepatic function
arm group type: Experimental
description: Participants with mild hepatic function will receive single oral dose of Pimodivir 600 mg (2*300 mg tablet) under fasted condition on Day 1. The recruitment in Part B will be started based on assessment by Sponsor upon evaluation of partial data obtained in Part A.
intervention type: Drug
intervention name: Pimodivir
description: Participants will receive single oral dose of Pimodivir 600 mg (2*300 mg tablets) under fasted condition on Day 1.
arm group label: Part A and B: Group 2: Normal hepatic function
arm group label: Part A: Group 1: Severe hepatic function
arm group label: Part B: Group 3: Moderate hepatic function
arm group label: Part B: Group 4: Mild hepatic function
other name: JNJ-63623872
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janssen-Cilag International NV Clinical Trial
role: Study Director
affiliation: Janssen-Cilag International NV
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Liver Diseases
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