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/NCT06024915</url>
    </required_header>
    <id_info>
      <org_study_id>TQ05105-I-04</org_study_id>
      <nct_id>NCT06024915</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate Drug-Drug Interaction of TQ05105 Tablets</brief_title>
    <official_title>A Phase I Study to Evaluate Drug-Drug Interaction of TQ05105 Tablets</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>
        This is a single-center, open, single-dose, self-controlled phase I clinical trial to&#xD;
        evaluate the effects of metabolic enzyme inhibitors/inducers on in vivo metabolic and&#xD;
        elimination of TQ05105 tablets, and the safety of metabolic enzyme inhibitors/inducers&#xD;
        combined with TQ05105 tablets.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">October 2023</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Maximum plasma concentration (Cmax)</measure>
      <time_frame>Up to 10 days.</time_frame>
      <description>Maximum plasma drug concentration after administration.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time to reach Cmax (Tmax)</measure>
      <time_frame>Up to 10 days.</time_frame>
      <description>Time to reach the maximum plasma concentration after administration.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Elimination half-life (t1/2)</measure>
      <time_frame>Up to 6 days.</time_frame>
      <description>The elimination half-life (t1/2) after oral dose of TQ05105 tablets and Itraconazole capsule.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Occurrence of adverse events (AE)</measure>
      <time_frame>Up to 30 days.</time_frame>
      <description>Including all adverse events (AE) and serious adverse events (SAE).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Myelofibrosis</condition>
    <arm_group>
      <arm_group_label>Itraconazole drug-durg interaction (DDI)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Itraconazole capsule: 0.2g once daily on Days 2 to Day 5; TQ05105 tablets: single oral dose on Days 1 and Day 5.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Rifampicin DDI</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Rifampicin Capsule: 0.6g once daily on Days 2 to Day 9; TQ05105 tablets: single oral dose on Days 1 and Day 9.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>TQ05105 tablets</intervention_name>
      <description>TQ05105 is a Janus kinase 2 (JAK2) inhibitor.</description>
      <arm_group_label>Itraconazole drug-durg interaction (DDI)</arm_group_label>
      <arm_group_label>Rifampicin DDI</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Itraconazole capsule</intervention_name>
      <description>Itraconazole is a strong inhibitor of cytochrome P450 3A (CYP3A).</description>
      <arm_group_label>Itraconazole drug-durg interaction (DDI)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Rifampicin Capsule</intervention_name>
      <description>Rifampicin is a strong inducer of CYP3A.</description>
      <arm_group_label>Rifampicin DDI</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  At the time of signing the informed consent, males or females between 18 and 45 years&#xD;
               of age;&#xD;
  &#xD;
            -  Female weight ≥ 45 kg, male weight ≥ 50 kg, with a body mass index (BMI) between 19&#xD;
               and 26 kg/m2.&#xD;
  &#xD;
            -  Subjects in good health, as determined by a medical history, vital signs, physical&#xD;
               examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations;&#xD;
  &#xD;
            -  Subjects can comply with the study procedures, voluntarily participate in the study,&#xD;
               and sign the informed consent in person.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subjects: preexisting or existing circulatory system, endocrine system, nervous&#xD;
               system, digestive system, respiratory system, genitourinary system, hematology,&#xD;
               immunology, psychiatry and metabolic disorders or abnormalities, or related chronic or&#xD;
               acute diseases, the investigator assesses that it is not appropriate to participate in&#xD;
               the trial；&#xD;
  &#xD;
            -  Subjects with Systemic/local acute infection before taking the study drug;&#xD;
  &#xD;
            -  Subjects who have a history of specific allergies, or allergic conditions (such as&#xD;
               allergies to two or more drugs, environments, or foods), or are known to be allergic&#xD;
               to components or analogs of the study drug;&#xD;
  &#xD;
            -  Subjects who have difficulty in swallowing or have any gastrointestinal disorder that&#xD;
               affects drug absorption at the time of screening；&#xD;
  &#xD;
            -  Subjects who cannot receive venous indwelling needle for blood sample collection；&#xD;
  &#xD;
            -  Subjects who drank regularly in the 6 months prior to first dosing, such as those who&#xD;
               drank more than 14 units of alcohol per week or who had a positive alcohol breath test&#xD;
               at the time of screening；&#xD;
  &#xD;
            -  Subjects who had a history of major surgery, or had taken the study drug, or had&#xD;
               participated in other drug clinical trials within 3 months prior to initial dosing；&#xD;
  &#xD;
            -  Subjects who donated blood or lost significant amounts of blood within 3 months prior&#xD;
               to initial dosing；&#xD;
  &#xD;
            -  Subjects who had used drugs within 3 months prior to first dosing, or tested positive&#xD;
               for drugs, or had a history of drug abuse within 5 years prior to screening；&#xD;
  &#xD;
            -  Subjects who smoked more than 5 cigarettes per day in the 3 months prior to initial&#xD;
               dosing or who could not stop using any tobacco products during the trial；&#xD;
  &#xD;
            -  Subjects who consumed excessive amounts of tea, coffee, and/or caffeinated beverages&#xD;
               daily in the 30 days prior to initial dosing；&#xD;
  &#xD;
            -  Subjects who have used any drug that inhibits or induces liver metabolism of the drug&#xD;
               in the 30 days prior to initial dosing；&#xD;
  &#xD;
            -  Subjects who have taken any prescription, over-the-counter, herbal, or health product&#xD;
               in the 14 days prior to initial dosing；&#xD;
  &#xD;
            -  Subjects who have taken a special diet or other factors affecting drug absorption,&#xD;
               distribution, metabolism, or excretion within 7 days prior to initial dosing；&#xD;
  &#xD;
            -  Subjects who ingested chocolate, any caffeinated, or xanthine-rich food or drink 48&#xD;
               hours before first dosing；&#xD;
  &#xD;
            -  Subjects who have special dietary requirements and cannot follow a uniform diet；&#xD;
  &#xD;
            -  Female subjects of child-bearing potential；&#xD;
  &#xD;
            -  Subjects judged by the investigator to be unsuitable to participate.&#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>
    <overall_contact>
      <last_name>Xin Wang, MD, PhD</last_name>
      <phone>86-0531-68778331</phone>
      <email>xinw007@126.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mei Ding, MD, PhD</last_name>
      <phone>+86 13864151105</phone>
      <email>dingmei1105@sina.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Shandong Provincial Hospital</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <zip>250021</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xin Wang, MD, PhD</last_name>
        <phone>86-0531-68778331</phone>
        <email>xinw007@126.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Itraconazole</mesh_term>
      <mesh_term>Rifampin</mesh_term>
    </intervention_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/NCT06024915
  org study id: TQ05105-I-04
  nct id: NCT06024915
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a single-center, open, single-dose, self-controlled phase I clinical trial to
        evaluate the effects of metabolic enzyme inhibitors/inducers on in vivo metabolic and
        elimination of TQ05105 tablets, and the safety of metabolic enzyme inhibitors/inducers
        combined with TQ05105 tablets.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Maximum plasma concentration (Cmax)
  time frame: Up to 10 days.
  description: Maximum plasma drug concentration after administration.
  measure: Time to reach Cmax (Tmax)
  time frame: Up to 10 days.
  description: Time to reach the maximum plasma concentration after administration.
  measure: Elimination half-life (t1/2)
  time frame: Up to 6 days.
  description: The elimination half-life (t1/2) after oral dose of TQ05105 tablets and Itraconazole capsule.
  measure: Occurrence of adverse events (AE)
  time frame: Up to 30 days.
  description: Including all adverse events (AE) and serious adverse events (SAE).
  arm group label: Itraconazole drug-durg interaction (DDI)
  arm group type: Experimental
  description: Itraconazole capsule: 0.2g once daily on Days 2 to Day 5; TQ05105 tablets: single oral dose on Days 1 and Day 5.
  arm group label: Rifampicin DDI
  arm group type: Experimental
  description: Rifampicin Capsule: 0.6g once daily on Days 2 to Day 9; TQ05105 tablets: single oral dose on Days 1 and Day 9.
  intervention type: Drug
  intervention name: TQ05105 tablets
  description: TQ05105 is a Janus kinase 2 (JAK2) inhibitor.
  arm group label: Itraconazole drug-durg interaction (DDI)
  arm group label: Rifampicin DDI
  intervention type: Drug
  intervention name: Itraconazole capsule
  description: Itraconazole is a strong inhibitor of cytochrome P450 3A (CYP3A).
  arm group label: Itraconazole drug-durg interaction (DDI)
  intervention type: Drug
  intervention name: Rifampicin Capsule
  description: Rifampicin is a strong inducer of CYP3A.
  arm group label: Rifampicin DDI
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Xin Wang, MD, PhD
  phone: 86-0531-68778331
  email: xinw007@126.com
  last name: Mei Ding, MD, PhD
  phone: +86 13864151105
  email: dingmei1105@sina.com
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Primary Myelofibrosis
  mesh term: Itraconazole
  mesh term: Rifampin