<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/NCT04479891</url>
  </required_header>
  <id_info>
    <org_study_id>HR-BLTN-DDI-01</org_study_id>
    <nct_id>NCT04479891</nct_id>
  </id_info>
  <brief_title>Effect of Itraconazole on the Pharmacokinetics of Pyrotinib in Healthy Subjects</brief_title>
  <official_title>A Single-centre, Open, Single-dose, Self-control Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of Pyrotinib in 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 study will assess the effect of multiple oral doses of itraconazole on the single dose&#xD;
      pharmacokinetic parameters of pyrotinib in healthy Chinese subjects. The safety of pyrotinib&#xD;
      alone and when co-administered with itraconazole will also be assessed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 18, 2019</start_date>
  <completion_date type="Actual">November 30, 2019</completion_date>
  <primary_completion_date type="Actual">October 11, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Pyrotinib alone and then combined with itraconazole</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax of pyrotinib</measure>
    <time_frame>Day 1 and Day 9</time_frame>
    <description>Maximum concentration (Cmax) of pyrotinib</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC of pyrotinib</measure>
    <time_frame>Day 1 and Day 9</time_frame>
    <description>Area under the plasma concentration versus time curve of SHR6390</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tmax of pyrotinib</measure>
    <time_frame>Day 1 and Day 9</time_frame>
    <description>Time of maximum concentration of pyrotinib</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T1/2 of pyrotinib</measure>
    <time_frame>Day 1 and Day 9</time_frame>
    <description>Terminal half-life of pyrotinib</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AEs and SAEs</measure>
    <time_frame>From the first drug administration to 7 days after the last drug administration</time_frame>
    <description>Adverse events and serious adverse events</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>pyrotinib alone, pyrotinib + itraconazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sequential treatments of pyrotinib alone followed by pyrotinib + itraconazole, with a washout period in between.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>pyrotinib tablet</intervention_name>
    <description>single oral dose of SHR6390 or co-administered with itraconazole</description>
    <arm_group_label>pyrotinib alone, pyrotinib + itraconazole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Itraconazole capsule</intervention_name>
    <description>200 mg itraconazole QD</description>
    <arm_group_label>pyrotinib alone, pyrotinib + itraconazole</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sign the informed consent before the trial, and fully understand the trial content,&#xD;
             process and possible adverse reactions;&#xD;
&#xD;
          -  Able to complete the study as required by the protocol;&#xD;
&#xD;
          -  Subjects have no birth plan and voluntarily take effective contraception from 2 weeks&#xD;
             before administration to 3 months after the last dose, and the pre-drug serum HCG test&#xD;
             for fertility-enabled women must be negative;&#xD;
&#xD;
          -  Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within&#xD;
             the range of 19 ~ 26 kg/m2 ;&#xD;
&#xD;
          -  No clinically significant abnormalities in general physical examination, vital signs,&#xD;
             laboratory tests, etc.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Blood donation no less than 400 mL or have blood transfusion within 3 months of&#xD;
             dosing.&#xD;
&#xD;
          -  Allergic constitution or known allergy to pyrotinib, itraconazole or the excipients;&#xD;
&#xD;
          -  History of drug abuse in the past 5 years, or positive for drug abuse screening;&#xD;
&#xD;
          -  Alcoholic or often drinkers with drinking amount more than 14 units a week; a heavy&#xD;
             smoker; and can't abstain from smoking and alcohol during the study&#xD;
&#xD;
          -  Left ventricular ejection fraction (LVEF) &lt;50% by echocardiography or QTcF ≥ 470 msec&#xD;
             by 12 lead electrocardiograph;&#xD;
&#xD;
          -  A clear medical history of important primary organ diseases such as nervous system,&#xD;
             cardiovascular system, urinary system, digestive system, respiratory system,&#xD;
             metabolism and musculoskeletal system that are not suitable for subjects to&#xD;
             participate in the study, as judged by the investigator;&#xD;
&#xD;
          -  Any surgery within 6 months before screening;&#xD;
&#xD;
          -  Have taken hepatotoxic drugs for a long time within 6 months before screening;&#xD;
&#xD;
          -  Subjects who took any clinical trial drugs within 3 months;&#xD;
&#xD;
          -  Subjects who took any drugs that change liver enzymes activity within 28 days before&#xD;
             dosing; or took any prescription drugs, over-the-counter drugs or vitamins, health&#xD;
             products or herbal medicine within 14 days before dosing;&#xD;
&#xD;
          -  Hepatitis B surface antigen positive, hepatitis C antibody positive, syphilis antibody&#xD;
             positive, HIV antibody positive;&#xD;
&#xD;
          -  Subjects who took any beverage or food containing grapefruit, xanthine, caffeine, or&#xD;
             alcohol within 48 hours before dosing; strenuous exercise; or other factors which&#xD;
             affect drug absorption, distribution, metabolism, excretion, etc.;&#xD;
&#xD;
          -  Other factors that are not suitable for subjects to participate in the study, as&#xD;
             judged by the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Second Hospital of Anhui Medical University</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230601</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Itraconazole</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/NCT04479891
org study id: HR-BLTN-DDI-01
nct id: NCT04479891
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study will assess the effect of multiple oral doses of itraconazole on the single dose
      pharmacokinetic parameters of pyrotinib in healthy Chinese subjects. The safety of pyrotinib
      alone and when co-administered with itraconazole will also be assessed.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Pyrotinib alone and then combined with itraconazole
primary purpose: Basic Science
masking: None (Open Label)
measure: Cmax of pyrotinib
time frame: Day 1 and Day 9
description: Maximum concentration (Cmax) of pyrotinib
measure: AUC of pyrotinib
time frame: Day 1 and Day 9
description: Area under the plasma concentration versus time curve of SHR6390
measure: Tmax of pyrotinib
time frame: Day 1 and Day 9
description: Time of maximum concentration of pyrotinib
measure: T1/2 of pyrotinib
time frame: Day 1 and Day 9
description: Terminal half-life of pyrotinib
measure: AEs and SAEs
time frame: From the first drug administration to 7 days after the last drug administration
description: Adverse events and serious adverse events
arm group label: pyrotinib alone, pyrotinib + itraconazole
arm group type: Experimental
description: Sequential treatments of pyrotinib alone followed by pyrotinib + itraconazole, with a washout period in between.
intervention type: Drug
intervention name: pyrotinib tablet
description: single oral dose of SHR6390 or co-administered with itraconazole
arm group label: pyrotinib alone, pyrotinib + itraconazole
intervention type: Drug
intervention name: Itraconazole capsule
description: 200 mg itraconazole QD
arm group label: pyrotinib alone, pyrotinib + itraconazole
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor
mesh term: Itraconazole