<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/NCT04494659</url>
  </required_header>
  <id_info>
    <org_study_id>FMTN-I-105</org_study_id>
    <nct_id>NCT04494659</nct_id>
  </id_info>
  <brief_title>A Drug-drug Interaction Trial to Evaluate the Pharmacokinetics Effect of Rifampicin on Famitinib</brief_title>
  <official_title>A Single Center, Single Arm, Open and Fixed Sequence Study to Investigate the Pharmacokinetic Effects of Rifampicin on Famitinib in Healthy Male 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>
    <has_dmc>No</has_dmc>
    <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 was to assess the effect of repeated oral doses of&#xD;
      Rifampicin on the pharmacokinetic profile of a single dose of Famitinib.&#xD;
&#xD;
      The secondary objective of the study was to assess the safety of Famitinib given alone versus&#xD;
      Famitinib co-administered with Rifampicin.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 13, 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>
    <intervention_model_description>Repeated oral doses of Rifampicin on the pharmacokinetic profile of a single dose of Famitinib.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax of Famitinib</measure>
    <time_frame>Day 1 to Day 24</time_frame>
    <description>Pharmacokinetics parameters of Famitinib</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-t of Famitinib</measure>
    <time_frame>Day 1 to Day 24</time_frame>
    <description>Pharmacokinetics parameters of Famitinib</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCinf of Famitinib</measure>
    <time_frame>Day 1 to Day 24</time_frame>
    <description>Pharmacokinetics parameters of Famitinib</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tmax of Famitinib</measure>
    <time_frame>Day 1 to Day 24</time_frame>
    <description>Pharmacokinetics parameters of Famitinib</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T1/2 of Famitinib</measure>
    <time_frame>Day 1 to Day 24</time_frame>
    <description>Pharmacokinetics parameters of Famitinib</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F of Famitinib</measure>
    <time_frame>Day 1 to Day 24</time_frame>
    <description>Pharmacokinetics parameters of Famitinib</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F of Famitinib</measure>
    <time_frame>Day 1 to Day 24</time_frame>
    <description>Pharmacokinetics parameters of Famitinib</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of adverse events/serious adverse events</measure>
    <time_frame>from ICF signing date to approximate Day 31</time_frame>
    <description>safety evaluation based on NCI-CTC AE 5.0</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Healthy Adult Subjects</condition>
  <arm_group>
    <arm_group_label>Single arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single dose of Famitinib on Day 1, and co-administered with Rifampicin on Day 16</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Famitinib capsule</intervention_name>
    <description>single dose and co-administrated with Rifampicin capsule</description>
    <arm_group_label>Single arm</arm_group_label>
    <other_name>SHR1020</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rifampicin capsule</intervention_name>
    <description>repeated doses of Rifampicin capsule</description>
    <arm_group_label>Single arm</arm_group_label>
    <other_name>Rifampicin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male subjects aged 18 to 50 years old at the date of signing the informed&#xD;
             consent;&#xD;
&#xD;
          2. Male body weight ≥ 50kg, body mass index (BMI) within the range of 19 ~ 28 kg/m2&#xD;
             (including 19 and 28) (BMI= weight (kg)/height 2 (m2));&#xD;
&#xD;
          3. Subjects have no childbirth plans and agree to take effective contraceptive measures&#xD;
             within 3 months of the last medication;&#xD;
&#xD;
          4. The subject can communicate well with the researcher, understand and comply with the&#xD;
             requirements of the study, understand and sign the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of or currently suffering from any serious clinical diseases such as diseases&#xD;
             in circulatory system, endocrine system, nervous system, digestive system, respiratory&#xD;
             system, genitourinary system, hematology, immunology, psychiatry, and metabolic&#xD;
             abnormalities, or any other diseases may interfere with the test results;&#xD;
&#xD;
          2. Any surgery within 6 months before screening, or plan to perform surgery during the&#xD;
             study period, or who have previously undergone any surgery that affects&#xD;
             gastrointestinal absorption (including gastrectomy, bowel resection, gastric reduction&#xD;
             surgery, etc.)&#xD;
&#xD;
          3. Blood donation or massive blood loss (≥200 mL), or received blood transfusion, or used&#xD;
             blood products within 3 months before screening;&#xD;
&#xD;
          4. History of allergy to drugs, food or other substances;&#xD;
&#xD;
          5. Frequent use of sedatives, sleeping pills or other addictive drugs; History of drug&#xD;
             abuse within 1 year prior to screening; Positive for urine drug abuse screening test;&#xD;
&#xD;
          6. Participated in any clinical trial and took the study drug within 3 months prior to&#xD;
             the first administration;&#xD;
&#xD;
          7. Used any prescription drug or herbal tonic within 1 month before the first&#xD;
             administration; Have used any over-the-counter (OTC) medicines, food supplements&#xD;
             (including vitamins, calcium tablets, etc.) within 2 weeks prior to the first&#xD;
             administration;&#xD;
&#xD;
          8. Those who had smoked more than 5 cigarettes per day in the previous 3 months before&#xD;
             screening and could not stop using any tobacco products during the study period;&#xD;
             Nicotinic test positive;&#xD;
&#xD;
          9. Frequent drinkers in the previous 6 months before screening, i.e., those who drink&#xD;
             more than 14 units of alcohol per week (1 unit = 285 mL beer, or 25 mL spirits, or 100&#xD;
             mL wine) and cannot stop using any alcoholic products during the study period; alcohol&#xD;
             test positive;&#xD;
&#xD;
         10. Abnormal vital signs, physical examination, 12-lead ECG, abdominal B-ultrasound, chest&#xD;
             radiograph, routine blood test, biochemical test, routine urine test and blood&#xD;
             coagulation test with clinical significance;&#xD;
&#xD;
         11. Hepatitis B surface antigen positive, hepatitis C antibody positive, syphilis antibody&#xD;
             positive, HIV antibody positive;&#xD;
&#xD;
         12. Subjects have taken and do not agree to stop using any drink or food containing&#xD;
             methylxanthine, such as coffee, tea, cola, chocolate, etc. from 48 hours before the&#xD;
             first administration until end of the study;, subjects have taken and do not agree to&#xD;
             discontinue any beverage or food containing grapefruit from 7 days prior to initial&#xD;
             administration until end of the study; Those who have special requirements on diet and&#xD;
             cannot follow a uniform diet;&#xD;
&#xD;
         13. Subjects who are considered to have other factors that are not appropriate to&#xD;
             participate in this study by the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Affiliated Hospital of Qingdao University</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <zip>266055</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>September 27, 2020</last_update_submitted>
  <last_update_submitted_qc>September 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 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>Rifampin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04494659
org study id: FMTN-I-105
nct id: NCT04494659
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of the study was to assess the effect of repeated oral doses of
      Rifampicin on the pharmacokinetic profile of a single dose of Famitinib.

      The secondary objective of the study was to assess the safety of Famitinib given alone versus
      Famitinib co-administered with Rifampicin.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Repeated oral doses of Rifampicin on the pharmacokinetic profile of a single dose of Famitinib.
primary purpose: Basic Science
masking: None (Open Label)
measure: Cmax of Famitinib
time frame: Day 1 to Day 24
description: Pharmacokinetics parameters of Famitinib
measure: AUC0-t of Famitinib
time frame: Day 1 to Day 24
description: Pharmacokinetics parameters of Famitinib
measure: AUCinf of Famitinib
time frame: Day 1 to Day 24
description: Pharmacokinetics parameters of Famitinib
measure: Tmax of Famitinib
time frame: Day 1 to Day 24
description: Pharmacokinetics parameters of Famitinib
measure: T1/2 of Famitinib
time frame: Day 1 to Day 24
description: Pharmacokinetics parameters of Famitinib
measure: CL/F of Famitinib
time frame: Day 1 to Day 24
description: Pharmacokinetics parameters of Famitinib
measure: Vz/F of Famitinib
time frame: Day 1 to Day 24
description: Pharmacokinetics parameters of Famitinib
measure: incidence of adverse events/serious adverse events
time frame: from ICF signing date to approximate Day 31
description: safety evaluation based on NCI-CTC AE 5.0
arm group label: Single arm
arm group type: Experimental
description: single dose of Famitinib on Day 1, and co-administered with Rifampicin on Day 16
intervention type: Drug
intervention name: Famitinib capsule
description: single dose and co-administrated with Rifampicin capsule
arm group label: Single arm
other name: SHR1020
intervention type: Drug
intervention name: Rifampicin capsule
description: repeated doses of Rifampicin capsule
arm group label: Single arm
other name: Rifampicin
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor
mesh term: Rifampin
sharing ipd: No