<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/NCT04423601</url>
  </required_header>
  <id_info>
    <org_study_id>SHR6390-I-106</org_study_id>
    <nct_id>NCT04423601</nct_id>
  </id_info>
  <brief_title>Effect of Itraconazole on the Pharmacokinetics of SHR6390 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 SHR6390 in Healthy Chinese Adult 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 evaluate the effect of itraconazole on&#xD;
      pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR6390&#xD;
      tablets. The secondary objective of the study is to evaluate the safety of SHR6390 alone and&#xD;
      when co-administered with itraconazole. The exploratory objective of the study is to explore&#xD;
      the effect of SHR6390 related metabolic enzymes and transporter gene polymorphisms on the&#xD;
      pharmacokinetics of SHR6390.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2020</start_date>
  <completion_date type="Actual">February 2, 2021</completion_date>
  <primary_completion_date type="Actual">July 29, 2020</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics parameter: Cmax of SHR6390</measure>
    <time_frame>through study completion, an average of 32 days</time_frame>
    <description>Peak Plasma Concentration (Cmax) of SHR6390</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics parameter: AUC of SHR6390</measure>
    <time_frame>through study completion, an average of 32 days</time_frame>
    <description>Area under the plasma concentration versus time curve (AUC) of SHR6390</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics parameter: Tmax of SHR6390</measure>
    <time_frame>through study completion, an average of 32 days</time_frame>
    <description>Time of maximum observed concentration (Tmax) of SHR6390</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics parameter: T1/2 of SHR6390</measure>
    <time_frame>through study completion, an average of 32 days</time_frame>
    <description>Half time (T1/2) of SHR6390</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics parameter: CL/F of SHR6390</measure>
    <time_frame>through study completion, an average of 32 days</time_frame>
    <description>Total body clearance for extravascular administration (CL/F) of SHR6390</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects receiving a single oral dose of SHR6390 tablets, then itraconazole capsules 200 mg/day orally with a single oral dose of SHR6390 tablets co-administered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SHR6390 tablet</intervention_name>
    <description>single oral dose of SHR6390 or co-administered with itraconazole.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Itraconazole capsule</intervention_name>
    <description>200 mg itraconazole was administered in the morning.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Sign the informed consent before the trial, and fully understand the trial content,&#xD;
             process and possible adverse reactions;&#xD;
&#xD;
          2. Ability to complete the study as required by the protocol;&#xD;
&#xD;
          3. Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of&#xD;
             signing the informed consent;&#xD;
&#xD;
          4. Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within&#xD;
             the range of 19 ~ 26 kg /m2 (including 19 and 26);&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Allergic constitution;&#xD;
&#xD;
          2. History of drug use, or drug abuse screening positive;&#xD;
&#xD;
          3. Alcoholic or often drinkers;&#xD;
&#xD;
          4. Left ventricular ejection fraction (LVEF) &lt;50% by echocardiography;&#xD;
&#xD;
          5. 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.&#xD;
&#xD;
          6. Abnormal clinical laboratory tests and clinical significance judged by the&#xD;
             investigator or other clinical findings showing the following diseases, including but&#xD;
             not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor,&#xD;
             lung, immune, mental or cardiovascular and cerebrovascular diseases.&#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>Sun Yat-sen Memorial Hospital, Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>October 11, 2021</last_update_submitted>
  <last_update_submitted_qc>October 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2021</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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04423601
org study id: SHR6390-I-106
nct id: NCT04423601
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The primary objective of the study is to evaluate the effect of itraconazole on
      pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR6390
      tablets. The secondary objective of the study is to evaluate the safety of SHR6390 alone and
      when co-administered with itraconazole. The exploratory objective of the study is to explore
      the effect of SHR6390 related metabolic enzymes and transporter gene polymorphisms on the
      pharmacokinetics of SHR6390.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Pharmacokinetics parameter: Cmax of SHR6390
time frame: through study completion, an average of 32 days
description: Peak Plasma Concentration (Cmax) of SHR6390
measure: Pharmacokinetics parameter: AUC of SHR6390
time frame: through study completion, an average of 32 days
description: Area under the plasma concentration versus time curve (AUC) of SHR6390
measure: Pharmacokinetics parameter: Tmax of SHR6390
time frame: through study completion, an average of 32 days
description: Time of maximum observed concentration (Tmax) of SHR6390
measure: Pharmacokinetics parameter: T1/2 of SHR6390
time frame: through study completion, an average of 32 days
description: Half time (T1/2) of SHR6390
measure: Pharmacokinetics parameter: CL/F of SHR6390
time frame: through study completion, an average of 32 days
description: Total body clearance for extravascular administration (CL/F) of SHR6390
arm group label: Treatment
arm group type: Experimental
description: subjects receiving a single oral dose of SHR6390 tablets, then itraconazole capsules 200 mg/day orally with a single oral dose of SHR6390 tablets co-administered.
intervention type: Drug
intervention name: SHR6390 tablet
description: single oral dose of SHR6390 or co-administered with itraconazole.
arm group label: Treatment
intervention type: Drug
intervention name: Itraconazole capsule
description: 200 mg itraconazole was administered in the morning.
arm group label: Treatment
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
sharing ipd: Undecided