<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/NCT04439578</url>
  </required_header>
  <id_info>
    <org_study_id>SHR6390-I-107</org_study_id>
    <nct_id>NCT04439578</nct_id>
  </id_info>
  <brief_title>Effect of Rifampicin 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 Rifampicin 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 rifampicin 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 rifampicin.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 23, 2020</start_date>
  <completion_date type="Actual">January 15, 2021</completion_date>
  <primary_completion_date type="Actual">August 17, 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>
  <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 rifampicin capsules 600 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 single oral dose of SHR6390 or co-administered with rifampicin</intervention_name>
    <description>600 mg rifampicin was administered in the morning.</description>
    <arm_group_label>Treatment</arm_group_label>
    <other_name>rifampicin</other_name>
  </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;
          5. Subjects shall ake effective contraceptive measures voluntarily within 3 months from&#xD;
             the date of signing the informed consent form to the date of the last medication.&#xD;
             Serum HCG test of fertile women before the study must be negative&#xD;
&#xD;
          6. Physical examination (vital signs, physical examination), routine laboratory&#xD;
             examination (blood routine, blood biochemistry, urine routine, coagulation function),&#xD;
             12-lead electrocardiogram, orthotopic chest X-ray and abdominal B-ultrasound are&#xD;
             normal or abnormal but have no clinical significance&#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;
&#xD;
          7. Participated in blood donation with blood donation volume ≥400 mL or received blood&#xD;
             transfusion within 3 months before screening.&#xD;
&#xD;
          8. Patients who have had any surgery and taken hepatotoxic drugs in the previous 6 months&#xD;
             before screening.&#xD;
&#xD;
          9. Patients who use any vitamin product or herb 14 days prior to screening.&#xD;
&#xD;
         10. HCV positive, HIV antibody positive, HBsAg positive, syphilis antibody positive.&#xD;
&#xD;
         11. Subjects who are considered unfit to participate in the study 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>Zhejiang provincial people's hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310014</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 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>Rifampin</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/NCT04439578
org study id: SHR6390-I-107
nct id: NCT04439578
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The primary objective of the study is to evaluate the effect of rifampicin 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 rifampicin.
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
arm group label: Treatment
arm group type: Experimental
description: subjects receiving a single oral dose of SHR6390 tablets, then rifampicin capsules 600 mg/day orally with a single oral dose of SHR6390 tablets co-administered.
intervention type: Drug
intervention name: SHR6390 tablet single oral dose of SHR6390 or co-administered with rifampicin
description: 600 mg rifampicin was administered in the morning.
arm group label: Treatment
other name: rifampicin
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: Rifampin
sharing ipd: Undecided