<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/NCT02998775</url>
  </required_header>
  <id_info>
    <org_study_id>E7080-A001-010</org_study_id>
    <nct_id>NCT02998775</nct_id>
  </id_info>
  <brief_title>Phase 0 Study in Healthy, Hepatic and Renal Impaired Subjects to Obtain Plasma for Lenvatinib Protein Binding</brief_title>
  <official_title>A Multicenter Phase 0 Study In Healthy Subjects and Subjects With Either Hepatic Or Renal Impairment To Obtain Plasma For Assessment In Vitro Lenvatinib Protein Binding</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eisai Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eisai Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or&#xD;
      severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy&#xD;
      participants. The primary objective of the study is to obtain plasma from participants for&#xD;
      use in in vitro protein binding studies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or&#xD;
      severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy&#xD;
      participants. Approximately 6 participants with each degree (mild, moderate, or severe) of&#xD;
      hepatic or renal impairment will be enrolled. Two cohorts of 8 healthy participants will be&#xD;
      enrolled. One cohort of healthy participants will be matched to the hepatic-impaired&#xD;
      participants, whereas the other will be matched to the renal-impaired participants.&#xD;
&#xD;
      The study has 2 phases. The Pre-study Phase consists of a Screening Period and a Baseline&#xD;
      Period. The Study Phase consists of a 2-day Study Period. No lenvatinib will be administered&#xD;
      in this study.&#xD;
&#xD;
      The end of the study will be the date of the last study visit for the last participant in the&#xD;
      study.&#xD;
&#xD;
      The following estimates are provided:&#xD;
&#xD;
        -  From first participant in to last participant out, the study is expected to take&#xD;
           approximately one year to complete.&#xD;
&#xD;
        -  The maximum estimated duration of the study for each participant is anticipated to be&#xD;
           approximately 5 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2, 2016</start_date>
  <completion_date type="Actual">July 8, 2017</completion_date>
  <primary_completion_date type="Actual">July 8, 2017</primary_completion_date>
  <phase>Early 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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with any serious adverse event and any non-serious adverse event</measure>
    <time_frame>1 week</time_frame>
  </primary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Hepatic Impairment; Renal Impairment</condition>
  <arm_group>
    <arm_group_label>6 participants with mild renal impairment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Renal Impairment Mild: creatinine clearance, 50 to 80 milliliters per minute (mL/min)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6 participants with moderate renal impairment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Renal Impairment Moderate: creatinine clearance, 30 to 49 mL/min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6 participants with severe renal impairment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Renal Impairment Severe: creatinine clearance, 15 to 29 mL/min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>8 participants normal renal status</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Renal status normal as defined by creatinine clearance ≥ 81 mL/min, otherwise age, gender, and smoking characteristics matching renal-impaired participants</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6 participants with mild hepatic impairment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Hepatic impairment mild: total score on the Child-Pugh classification system between 5 and 6</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6 participants with moderate hepatic impairment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Hepatic impairment moderate: total score on the Child-Pugh classification system between 7 and 9</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6 participants with severe hepatic impairment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Hepatic impairment severe: total score on the Child-Pugh classification system between 10 and 15</description>
  </arm_group>
  <arm_group>
    <arm_group_label>8 participants normal hepatic status</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Hepatic status normal, otherwise age, gender, and smoking characteristics matching hepatic-impaired participants</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Plasma Sampling</intervention_name>
    <description>No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.</description>
    <arm_group_label>6 participants with mild hepatic impairment</arm_group_label>
    <arm_group_label>6 participants with mild renal impairment</arm_group_label>
    <arm_group_label>6 participants with moderate hepatic impairment</arm_group_label>
    <arm_group_label>6 participants with moderate renal impairment</arm_group_label>
    <arm_group_label>6 participants with severe hepatic impairment</arm_group_label>
    <arm_group_label>6 participants with severe renal impairment</arm_group_label>
    <arm_group_label>8 participants normal hepatic status</arm_group_label>
    <arm_group_label>8 participants normal renal status</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Male or Female&#xD;
&#xD;
          -  Age, at the time of Informed Consent:&#xD;
&#xD;
             i. Hepatic Impairment Participants (Including Matched Healthy Participants): 18 to 70&#xD;
             years old, inclusive ii. Renal Impairment Participants (Including Matched Healthy&#xD;
             Participants): 18 to 79 years old, inclusive&#xD;
&#xD;
          -  Non-smokers and smokers who smoke no more than 10 cigarettes per day&#xD;
&#xD;
          -  Besides diabetes and, as appropriate, renal or hepatic impairment, participants must&#xD;
             have no history of acute or chronic clinically relevant disease or condition, as&#xD;
             determined by the investigator.&#xD;
&#xD;
          -  For participants with hepatic impairment:&#xD;
&#xD;
               -  Liver cirrhosis that has been stable;&#xD;
&#xD;
               -  Platelet count &gt;30,000 cells/millimeter cubed (mm^3);&#xD;
&#xD;
               -  Total score on the Child-Pugh classification system between 5 and 6 (Group 1,&#xD;
                  mild), 7 and 9 (Group 2, moderate), and 10 and 15 (Group 3, severe)&#xD;
&#xD;
          -  For healthy participants:&#xD;
&#xD;
             • Creatinine clearance ≥ 81 milliliter per minute (mL/min)&#xD;
&#xD;
          -  For participants with renal impairment:&#xD;
&#xD;
               -  Must have a diagnosis of renal impairment that has been stable&#xD;
&#xD;
               -  Must have renal impairment in the following categories based on creatinine&#xD;
                  clearance values: mild (creatinine clearance, 50 to 80 mL/min), moderate&#xD;
                  (creatinine clearance, 30 to 49 mL/min), or severe (creatinine clearance, 15 to&#xD;
                  29 mL/min) renal impairment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Use of any new medication&#xD;
&#xD;
          -  Human immunodeficiency virus (HIV) positive&#xD;
&#xD;
          -  Presence of acute active liver disease or acute liver injury&#xD;
&#xD;
          -  History of significant cardiovascular impairment&#xD;
&#xD;
          -  Positive drug or alcohol test&#xD;
&#xD;
          -  Weight loss or gain of &gt;10% prior to Day 1&#xD;
&#xD;
          -  Receipt of blood or blood products or donation of blood or blood products&#xD;
&#xD;
        For participants with hepatic impairment:&#xD;
&#xD;
          -  History of hepatic transplant, systemic lupus erythematosus, or hepatic coma&#xD;
&#xD;
          -  Received treatment with interferon or pegylated interferon&#xD;
&#xD;
          -  Participants who have encephalopathy &gt;Grade 2, sepsis, or gastrointestinal bleeding;&#xD;
             esophageal varices &gt;Grade 2, acute hepatic failure of any etiology, history of&#xD;
             surgical portosystemic shunt, renal impairment (creatinine clearance &lt;50 mL/min&#xD;
             according to the Cockcroft-Gault formula), and rapidly deteriorating hepatic function&#xD;
&#xD;
          -  Systolic blood pressure (SBP) ≥ 160 millimeters of mercury (mmHg) and/or diastolic&#xD;
             blood pressure (DBP) ≥ 100 mmHg&#xD;
&#xD;
        For healthy participants:&#xD;
&#xD;
        • Hemoglobin level less than 12.0 grams per deciliter (g/dL)&#xD;
&#xD;
        For participants with renal impairment:&#xD;
&#xD;
          -  A history of renal transplant&#xD;
&#xD;
          -  SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg for participants with mild renal impairment; SBP&#xD;
             ≥ 180 mmHg and/or DBP ≥ 110 mmHg for participants with moderate and severe renal&#xD;
             impairment&#xD;
&#xD;
          -  Significant bleeding diathesis&#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>
  <location>
    <facility>
      <name>Orlando Clinical Research Center, Inc.</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DaVita Clinical Research</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Orleans Center for Clinical Research</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>September 6, 2018</last_update_submitted>
  <last_update_submitted_qc>September 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>in vitro protein binding</keyword>
  <keyword>hepatic impairment</keyword>
  <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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02998775
org study id: E7080-A001-010
nct id: NCT02998775
lead sponsor: 
has dmc: No
E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or
      severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy
      participants. The primary objective of the study is to obtain plasma from participants for
      use in in vitro protein binding studies.
E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or
      severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy
      participants. Approximately 6 participants with each degree (mild, moderate, or severe) of
      hepatic or renal impairment will be enrolled. Two cohorts of 8 healthy participants will be
      enrolled. One cohort of healthy participants will be matched to the hepatic-impaired
      participants, whereas the other will be matched to the renal-impaired participants.

      The study has 2 phases. The Pre-study Phase consists of a Screening Period and a Baseline
      Period. The Study Phase consists of a 2-day Study Period. No lenvatinib will be administered
      in this study.

      The end of the study will be the date of the last study visit for the last participant in the
      study.

      The following estimates are provided:

        -  From first participant in to last participant out, the study is expected to take
           approximately one year to complete.

        -  The maximum estimated duration of the study for each participant is anticipated to be
           approximately 5 weeks.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Number of participants with any serious adverse event and any non-serious adverse event
time frame: 1 week
arm group label: 6 participants with mild renal impairment
arm group type: Other
description: Renal Impairment Mild: creatinine clearance, 50 to 80 milliliters per minute (mL/min)
arm group label: 6 participants with moderate renal impairment
arm group type: Other
description: Renal Impairment Moderate: creatinine clearance, 30 to 49 mL/min
arm group label: 6 participants with severe renal impairment
arm group type: Other
description: Renal Impairment Severe: creatinine clearance, 15 to 29 mL/min
arm group label: 8 participants normal renal status
arm group type: Other
description: Renal status normal as defined by creatinine clearance ≥ 81 mL/min, otherwise age, gender, and smoking characteristics matching renal-impaired participants
arm group label: 6 participants with mild hepatic impairment
arm group type: Other
description: Hepatic impairment mild: total score on the Child-Pugh classification system between 5 and 6
arm group label: 6 participants with moderate hepatic impairment
arm group type: Other
description: Hepatic impairment moderate: total score on the Child-Pugh classification system between 7 and 9
arm group label: 6 participants with severe hepatic impairment
arm group type: Other
description: Hepatic impairment severe: total score on the Child-Pugh classification system between 10 and 15
arm group label: 8 participants normal hepatic status
arm group type: Other
description: Hepatic status normal, otherwise age, gender, and smoking characteristics matching hepatic-impaired participants
intervention type: Drug
intervention name: Plasma Sampling
description: No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
arm group label: 6 participants with mild hepatic impairment
arm group label: 6 participants with mild renal impairment
arm group label: 6 participants with moderate hepatic impairment
arm group label: 6 participants with moderate renal impairment
arm group label: 6 participants with severe hepatic impairment
arm group label: 6 participants with severe renal impairment
arm group label: 8 participants normal hepatic status
arm group label: 8 participants normal renal status
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Renal Insufficiency
sharing ipd: No