xml: <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/NCT05982106</url>
    </required_header>
    <id_info>
      <org_study_id>TQ05105-I-03</org_study_id>
      <nct_id>NCT05982106</nct_id>
    </id_info>
    <brief_title>To Evaluate the Effect of Food on the Pharmacokinetics of TQ05105 Tablets in Healthy Adult Subjects</brief_title>
    <official_title>A Randomized, Open-label, Single-center, Two-cycle, Two-crossover Phase I Clinical Trial Evaluating the Effect of Food on the Pharmacokinetics of TQ05105 Tablets in Healthy Adult Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chia Tai Tianqing Pharmaceutical Group Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chia Tai Tianqing Pharmaceutical Group 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>
        TQ05105 is a class 1 new drug with a new chemical structure developed by Chia Tai Tianqing&#xD;
        Pharmaceutical Group Co., Ltd. It is a Janus Kinase 2 （JAK2）inhibitor and can be used to&#xD;
        treat JAK2 target-related diseases. This study is a randomized, open-label, single-center,&#xD;
        two-cycle, two-crossover Phase I clinical trial evaluating the effect of food on the&#xD;
        pharmacokinetics of TQ05105 tablets in healthy adult subjects. Pharmacokinetic effects and&#xD;
        safety after oral administration of TQ05105 tablets.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 19, 2021</start_date>
    <completion_date type="Actual">July 28, 2021</completion_date>
    <primary_completion_date type="Actual">July 28, 2021</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Area under the drug-time curve (AUC)</measure>
      <time_frame>1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration</time_frame>
      <description>Area under the drug-time curve</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum Concentration (Cmax)</measure>
      <time_frame>1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration</time_frame>
      <description>Maximum concentration</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time to maximum concentration following drug administration (Tmax)</measure>
      <time_frame>1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration</time_frame>
      <description>Time to maximum concentration following drug administration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apparent terminal elimination half-life following drug administration (t1/2)</measure>
      <time_frame>1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration</time_frame>
      <description>Apparent terminal elimination half-life following drug administration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apparent volume of distribution (Vd/F)</measure>
      <time_frame>1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration</time_frame>
      <description>Apparent volume of distribution</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clearance rate (CL/F)</measure>
      <time_frame>1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration</time_frame>
      <description>Clearance rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse event rate</measure>
      <time_frame>Baseline up to 24 hours after administration</time_frame>
      <description>The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body temperature</measure>
      <time_frame>1 hour before administration and 1, 4, 12, 24 hours after administration</time_frame>
      <description>Monitor the safety indicators of subjects during the trial</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pulse</measure>
      <time_frame>1 hour before administration and 1, 4, 12, 24 hours after administration</time_frame>
      <description>Monitor the safety indicators of subjects during the trial</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood pressure</measure>
      <time_frame>1 hour before administration and 1, 4, 12, 24 hours after administration</time_frame>
      <description>Monitor the safety indicators of subjects during the trial</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">16</enrollment>
    <condition>Myelofibrosis</condition>
    <arm_group>
      <arm_group_label>TQ05105 Tablets (fasted)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>TQ05105 tablets was administered on fasted state in the first cycle for Group A and the second cycle for Group B.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>TQ05105 Tablets (fed)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>TQ05105 tablets was administered on fed state in the second cycle for Group A and the first cycle for Group B.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>TQ05105 Tablets</intervention_name>
      <description>TQ05105 tablet is a novel JAK2 inhibitor.</description>
      <arm_group_label>TQ05105 Tablets (fasted)</arm_group_label>
      <arm_group_label>TQ05105 Tablets (fed)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1 Sign the informed consent form before the test, and fully understand the test&#xD;
               content, process and possible adverse reactions;&#xD;
  &#xD;
            -  2 Able to communicate well, understand and complete the research in accordance with&#xD;
               the requirements of the experimental protocol;&#xD;
  &#xD;
            -  3 Male and female subjects aged 18 to 65 (including 18 and 65 years old);&#xD;
  &#xD;
            -  4 Body mass index (BMI) ≥ 18 and ≤ 28kg/m2, and male weight ≥ 50 kg and female weight&#xD;
               ≥ 45 kg;&#xD;
  &#xD;
            -  5 Health status: no history of heart, liver, kidney, digestive tract, nervous system,&#xD;
               mental abnormalities and metabolic abnormalities, and physical examination showed&#xD;
               normal or abnormal blood pressure, heart rate, electrocardiogram, respiratory system,&#xD;
               liver, kidney function and blood picture without clinical significance;&#xD;
  &#xD;
            -  6 The subjects have no pregnancy plans and voluntarily take effective contraceptive&#xD;
               measures from 2 weeks before the administration to at least 6 months after the last&#xD;
               use of the study drug.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1 Patients with neuropsychiatric system, respiratory system, cardiovascular system,&#xD;
               digestive tract system, blood-lymphatic system, liver and kidney insufficiency,&#xD;
               endocrine system, musculoskeletal system disease or other diseases in the past, and&#xD;
               the researcher judges that the past medical history may have an adverse effect on the&#xD;
               drug. Metabolic or safety effects;&#xD;
  &#xD;
            -  2 Those with allergic constitution or a history of two or more food or drug allergies&#xD;
               in the past;&#xD;
  &#xD;
            -  3 Those with multiple factors that affect oral drugs (such as inability to swallow,&#xD;
               gastrointestinal diseases);&#xD;
  &#xD;
            -  4 Taking any prescription, over-the-counter, vitamin product or herbal medicine within&#xD;
               1 month before taking the study drug;&#xD;
  &#xD;
            -  5 Take CYP3A4 inhibitors or inducers within 1 month before screening or before study&#xD;
               medication;&#xD;
  &#xD;
            -  6 Those who have taken special diets (including grapefruit, etc.) or exercised&#xD;
               vigorously within 14 days before screening, or have other factors that affect drug&#xD;
               absorption, distribution, metabolism, and excretion;&#xD;
  &#xD;
            -  7 aboratory examinations during the screening period are abnormal and have clinical&#xD;
               significance;&#xD;
  &#xD;
            -  8 Blood donation or massive blood loss (&gt; 450mL) within 3 months before taking the&#xD;
               study drug;&#xD;
  &#xD;
            -  9 Participated in any drug clinical trial within 3 months before taking the study&#xD;
               drug;&#xD;
  &#xD;
            -  10 Smoking more than 5 cigarettes per day within 3 months before the test;&#xD;
  &#xD;
            -  11 Positive breath test for alcohol or a history of alcohol abuse within 2 weeks&#xD;
               before screening (drinking 14 units of alcohol per week: 1 unit = 360mL of beer or&#xD;
               45mL of spirits with an alcohol content of 40% or 150mL of wine);&#xD;
  &#xD;
            -  12 Those who are positive for drug screening or have used drugs in the 3 months before&#xD;
               the test;&#xD;
  &#xD;
            -  13 Inability to tolerate venipuncture for blood collection or poor vascular condition;&#xD;
  &#xD;
            -  14 Subjects have a history of herpes zoster within 1 month before screening;&#xD;
  &#xD;
            -  15 The subject is unable to complete the trial due to personal reasons;&#xD;
  &#xD;
            -  16 Other investigators deem it unsuitable for enrollment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Affiliated Hospital of Changchun University of Traditional Chinese Medicine</name>
        <address>
          <city>Changchun</city>
          <state>Jilin</state>
          <zip>130103</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</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>Primary Myelofibrosis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05982106
  org study id: TQ05105-I-03
  nct id: NCT05982106
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  TQ05105 is a class 1 new drug with a new chemical structure developed by Chia Tai Tianqing
        Pharmaceutical Group Co., Ltd. It is a Janus Kinase 2 （JAK2）inhibitor and can be used to
        treat JAK2 target-related diseases. This study is a randomized, open-label, single-center,
        two-cycle, two-crossover Phase I clinical trial evaluating the effect of food on the
        pharmacokinetics of TQ05105 tablets in healthy adult subjects. Pharmacokinetic effects and
        safety after oral administration of TQ05105 tablets.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Area under the drug-time curve (AUC)
  time frame: 1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration
  description: Area under the drug-time curve
  measure: Maximum Concentration (Cmax)
  time frame: 1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration
  description: Maximum concentration
  measure: Time to maximum concentration following drug administration (Tmax)
  time frame: 1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration
  description: Time to maximum concentration following drug administration
  measure: Apparent terminal elimination half-life following drug administration (t1/2)
  time frame: 1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration
  description: Apparent terminal elimination half-life following drug administration
  measure: Apparent volume of distribution (Vd/F)
  time frame: 1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration
  description: Apparent volume of distribution
  measure: Clearance rate (CL/F)
  time frame: 1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration
  description: Clearance rate
  measure: Adverse event rate
  time frame: Baseline up to 24 hours after administration
  description: The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
  measure: Body temperature
  time frame: 1 hour before administration and 1, 4, 12, 24 hours after administration
  description: Monitor the safety indicators of subjects during the trial
  measure: Pulse
  time frame: 1 hour before administration and 1, 4, 12, 24 hours after administration
  description: Monitor the safety indicators of subjects during the trial
  measure: Blood pressure
  time frame: 1 hour before administration and 1, 4, 12, 24 hours after administration
  description: Monitor the safety indicators of subjects during the trial
  arm group label: TQ05105 Tablets (fasted)
  arm group type: Experimental
  description: TQ05105 tablets was administered on fasted state in the first cycle for Group A and the second cycle for Group B.
  arm group label: TQ05105 Tablets (fed)
  arm group type: Experimental
  description: TQ05105 tablets was administered on fed state in the second cycle for Group A and the first cycle for Group B.
  intervention type: Drug
  intervention name: TQ05105 Tablets
  description: TQ05105 tablet is a novel JAK2 inhibitor.
  arm group label: TQ05105 Tablets (fasted)
  arm group label: TQ05105 Tablets (fed)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Primary Myelofibrosis