<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/NCT04414852</url>
  </required_header>
  <id_info>
    <org_study_id>HR-APTN-I-011</org_study_id>
    <nct_id>NCT04414852</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Pharmacokinetics of Apatinib in Subjects With Impaired Renal Function</brief_title>
  <official_title>A Multi-center, Non-randomized, Open-label, Parallel Study to Evaluate the Pharmacokinetics of Apatinib Mesylate in Subjects With Impaired Renal Function and Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu HengRui Medicine Co., Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to compare the pharmacokinetics of apatinib in subjects&#xD;
      with impaired renal function and healthy subjects, to give dose recommendations for patients&#xD;
      with impaired renal function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 5, 2020</start_date>
  <completion_date type="Anticipated">April 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 15, 2021</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>Cmax</measure>
    <time_frame>0-96 hours</time_frame>
    <description>Maximum plasma concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-t</measure>
    <time_frame>0-96 hours</time_frame>
    <description>Area under the plasma concentration versus time curve from zero to 96h</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-∞</measure>
    <time_frame>0-96 hours</time_frame>
    <description>Area under the plasma concentration versus time curve from zero to infinity</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Subjects With Impaired Renal Function and Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>mild renal impairment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>moderate remal impairment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>normal renal impairment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apatinib Mesylate</intervention_name>
    <description>All the subjects will be administrated with 250mg apatinib on day 1</description>
    <arm_group_label>mild renal impairment</arm_group_label>
    <arm_group_label>moderate remal impairment</arm_group_label>
    <arm_group_label>normal renal impairment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        for subjects with impaired renal function&#xD;
&#xD;
          -  Able to comprehend and willing to sign an informed consent form (ICF)&#xD;
&#xD;
          -  18-70 years of age.&#xD;
&#xD;
          -  19 kg/m2&lt;BMI &lt;19-28 kg/m2&#xD;
&#xD;
          -  eGFR (MDRD equation) for mild impaired renal function: 60-89 mL/min/1.73 m2 eGFR (MDRD&#xD;
             equation) for moderate impaired renal function: 30-59 mL/min/1.73 m2&#xD;
&#xD;
          -  In good health, except for kidney disease and complications, determined by no&#xD;
             clinically significant findings from medical history, physical examination, 12-lead&#xD;
             ECG;&#xD;
&#xD;
          -  Agree to take approved method of contraception during the clinical trail and 8 weeks&#xD;
             after the last dose of apatinib. Female subject should be negative in the pregnancy&#xD;
             test;&#xD;
&#xD;
        for healthy subjects:&#xD;
&#xD;
          -  Able to comprehend and willing to sign an informed consent form (ICF)&#xD;
&#xD;
          -  18-70 years of age.&#xD;
&#xD;
          -  19 kg/m2&lt;BMI &lt;19-28 kg/m2&#xD;
&#xD;
          -  eGFR (MDRD equation) for mild impaired renal function: ≥90mL/min/1.73 m2&#xD;
&#xD;
          -  In good health, determined by no clinically significant findings from medical history,&#xD;
             physical examination, 12-lead ECG;&#xD;
&#xD;
          -  Agree to take approved method of contraception during the clinical trail and 8 weeks&#xD;
             after the last dose of apatinib. Female subject should be negative in the pregnancy&#xD;
             test;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        for subjects with renal impairment&#xD;
&#xD;
          -  Renal allograft recipients;&#xD;
&#xD;
          -  Need hemodialysis during study;&#xD;
&#xD;
          -  Uroclepsia or anuria;&#xD;
&#xD;
          -  Allergic to apatinib or ingredients;&#xD;
&#xD;
          -  History of heart disease in 12 months before study;&#xD;
&#xD;
          -  Coagulation disorders;&#xD;
&#xD;
          -  Hypertension and could not be controlled with hypotensor;&#xD;
&#xD;
          -  With hepatic or archenteric disease;&#xD;
&#xD;
          -  Participate in blood donation within 3 months before screening and donate blood volume&#xD;
             ≥400mL, or receive blood transfusion, or donate blood volume≥200mL within 1 month&#xD;
             prior dosing.&#xD;
&#xD;
          -  Take any clinical trial drugs within 3 months prior dosing;&#xD;
&#xD;
          -  Take any drugs that have effect on gastric acid and metabolic enzyme CYP 3A in 14 days&#xD;
             before dosing;&#xD;
&#xD;
          -  Addicted to alcohol and tobacco, drinking 14 units of alcohol per week (1 unit = 285&#xD;
             mL of beer, or 100mL of wine), or take ≥5 cigarettes;&#xD;
&#xD;
          -  Positive in urine drug test;&#xD;
&#xD;
          -  Combined with other viral infections (anti-HCV, anti-HIV positive, HBsAg positive) or&#xD;
             combined with syphilis infection;&#xD;
&#xD;
          -  Anyone who refuse to stop ingesting drinks containing methylxanthine, or grapefruit or&#xD;
             grapefruit-containing products from 48 hours before dosing to the end of the study;&#xD;
&#xD;
          -  The investigator believes that the subjects are not eligible to participate in this&#xD;
             trial.&#xD;
&#xD;
        for healthy subjects:&#xD;
&#xD;
          -  Renal allograft recipients;&#xD;
&#xD;
          -  Allergic to apatinib or ingredients;&#xD;
&#xD;
          -  History of heart disease in 12 months before study;&#xD;
&#xD;
          -  Coagulation disorders;&#xD;
&#xD;
          -  Hypertension and could not be controlled with hypotensor;&#xD;
&#xD;
          -  With hepatic or archenteric disease;&#xD;
&#xD;
          -  Participate in blood donation within 3 months before screening and donate blood volume&#xD;
             ≥400mL, or receive blood transfusion, or donate blood volume≥200mL within 1 month&#xD;
             prior dosing.&#xD;
&#xD;
          -  Take any clinical trial drugs within 3 months prior dosing;&#xD;
&#xD;
          -  Take any drugs that have effect on gastric acid and metabolic enzyme CYP 3A in 14 days&#xD;
             before dosing;&#xD;
&#xD;
          -  Addicted to alcohol and tobacco, drinking 14 units of alcohol per week (1 unit =285 mL&#xD;
             of beer, or 100mL of wine), or take ≥5 cigarettes;&#xD;
&#xD;
          -  Positive in urine drug test;&#xD;
&#xD;
          -  Combined with other viral infections (anti-HCV, anti-HIV positive, HBsAg positive) or&#xD;
             combined with syphilis infection;&#xD;
&#xD;
          -  Anyone who refuse to stop ingesting drinks containing methylxanthine, or grapefruit or&#xD;
             grapefruit-containing products from 48 hours before dosing to the end of the study;&#xD;
&#xD;
          -  The investigator believes that the subjects are not eligible to participate in this&#xD;
             trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yuya Wang</last_name>
    <phone>13918749176</phone>
    <email>wangyuya@hrglobe.cn</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 2, 2020</last_update_submitted>
  <last_update_submitted_qc>June 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 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>Renal Insufficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apatinib</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/NCT04414852
org study id: HR-APTN-I-011
nct id: NCT04414852
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The primary objective of the study is to compare the pharmacokinetics of apatinib in subjects
      with impaired renal function and healthy subjects, to give dose recommendations for patients
      with impaired renal function.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Cmax
time frame: 0-96 hours
description: Maximum plasma concentration
measure: AUC0-t
time frame: 0-96 hours
description: Area under the plasma concentration versus time curve from zero to 96h
measure: AUC0-∞
time frame: 0-96 hours
description: Area under the plasma concentration versus time curve from zero to infinity
arm group label: mild renal impairment
arm group type: Experimental
arm group label: moderate remal impairment
arm group type: Experimental
arm group label: normal renal impairment
arm group type: Active Comparator
intervention type: Drug
intervention name: Apatinib Mesylate
description: All the subjects will be administrated with 250mg apatinib on day 1
arm group label: mild renal impairment
arm group label: moderate remal impairment
arm group label: normal renal impairment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yuya Wang
phone: 13918749176
email: wangyuya@hrglobe.cn
responsible party type: Sponsor
mesh term: Renal Insufficiency
mesh term: Apatinib