<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/NCT04477096</url>
  </required_header>
  <id_info>
    <org_study_id>HS-10234-108</org_study_id>
    <nct_id>NCT04477096</nct_id>
  </id_info>
  <brief_title>Evaluation of Drug Interaction Between HS-10234 and Emtriccitabine</brief_title>
  <official_title>Study on the Drug Interaction of HS-10234 and Emtricitabine in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu Hansoh Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu Hansoh Pharmaceutical 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 study is being conducted to evaluate drug interaction between HS-10234 and Emtricitabine&#xD;
      after multiple dose in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study includes two parts. Part 1 is to evaluate the impact of Emtricitabine on HS-10234.&#xD;
      Part 2 is to evaluate the impact of HS-10234 on Emtricitabine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2020</start_date>
  <completion_date type="Actual">September 24, 2020</completion_date>
  <primary_completion_date type="Actual">September 24, 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>Sequential Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics parameters of HS-10234 and it's metabolite tenofovir, Emtricitabine</measure>
    <time_frame>0 - 24 hour on 7th day</time_frame>
    <description>Cmax</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics parameters of HS-10234 and it's metabolite tenofovir, Emtricitabine</measure>
    <time_frame>0 - 24 hour on 7th day</time_frame>
    <description>AUC0-tau</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concentration of HS-10234's metabolite tenofovir-diphosphate in peripheral blood mononuclear cells.</measure>
    <time_frame>0 - 24 hour on 7th day</time_frame>
    <description>Concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of AEs,</measure>
    <time_frame>0 - 23 day</time_frame>
    <description>laboratory abnormalities (based on hematology, biochemistry, and urinalysis tests)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of AEs,</measure>
    <time_frame>0 - 23 day</time_frame>
    <description>body temperature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of AEs,</measure>
    <time_frame>0 - 23 day</time_frame>
    <description>respiratory rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of AEs,</measure>
    <time_frame>0 - 23 day</time_frame>
    <description>blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of AEs,</measure>
    <time_frame>0 - 23 day</time_frame>
    <description>pulse rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of AEs,</measure>
    <time_frame>0 - 23 day</time_frame>
    <description>Resting 12-lead ECG parameters（ECG QT Interval）</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>single arm for each part: two arms</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>PART1:In the first period, HS-10234 will be administered at 25 mg QD for 7 days. In the second period, HS-10234 at 25 mg in combination with Emtricitabine at 200 mg will be administered QD for 7 days.&#xD;
PART2:In the first period, Emtricitabine will be administered at 200 mg QD for 7 days. In the second period, HS-10234 at 25 mg in combination with Emtricitabine at 200 mg will be administered QD for 7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HS-10234</intervention_name>
    <description>HS-10234</description>
    <arm_group_label>single arm for each part: two arms</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Emtricitabine</intervention_name>
    <description>Emtricitabine</description>
    <arm_group_label>single arm for each part: two arms</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Voluntarily sign an informed consent before any activities related to this trial and&#xD;
             understand the procedures and methods of this trial;&#xD;
&#xD;
          2. Aged between 18 and 55 years old (including cutoff value), both male and female;&#xD;
&#xD;
          3. Male body weight ≥50.0kg, female body weight ≥45.0kg, body mass index (BMI) is 19~26&#xD;
             kg/m2 (including both ends);&#xD;
&#xD;
          4. Those who signed the informed consent form and had no birth plan within 3 months after&#xD;
             the last dose and agreed to take effective contraceptive measures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. People who have been or are currently suffering from any clinically serious diseases&#xD;
             such as circulatory system, endocrine system, nervous system, digestive system,&#xD;
             respiratory system, hematology, immunology, psychiatry and metabolic abnormalities, or&#xD;
             any other diseases that can interfere with the test results, Or have a stomach problem&#xD;
             or have a history of stomach problems;&#xD;
&#xD;
          2. People who have drugs (penicillin or cephalosporin drugs), food, or have a history of&#xD;
             allergy to test drugs or similar drugs;&#xD;
&#xD;
          3. If the subject have a history of surgery within the 4 weeks prior to the trial or plan&#xD;
             to undergo surgery during the study period or have surgery that affected the&#xD;
             absorption, distribution, metabolism, and excretion of drugs;&#xD;
&#xD;
          4. Those who took any prescription drugs, over-the-counter drugs, Chinese herbal&#xD;
             medicines or health products within 14 days before taking the study drug, or those who&#xD;
             were within 5 half-lives of the drug at the time of screening; those who plan to take&#xD;
             non-study drugs or health products during the trial;&#xD;
&#xD;
          5. Those who participated in any drug clinical trial and used any trial drug within 3&#xD;
             months before administration (subject to the informed consent);&#xD;
&#xD;
          6. Participate in blood donation within 3 months before administration and the amount of&#xD;
             blood donation &gt;200 mL, or have received blood transfusion;&#xD;
&#xD;
          7. Unable or unwilling to follow the lifestyle guidelines required in the plan;&#xD;
&#xD;
          8. Smokers or those who smoked more than 5 cigarettes per day in the 3 months before the&#xD;
             trial;&#xD;
&#xD;
          9. Alcoholics or frequent drinkers within 6 months before the test, that is, drinking&#xD;
             more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40%&#xD;
             alcohol or 150 mL of wine) or before administration Alcohol screening positive;&#xD;
&#xD;
         10. People who have a history of drug abuse, drug dependence, or a positive drug screen&#xD;
             before administration;&#xD;
&#xD;
         11. Screening/baseline visit to alanine aminotransferase and/or aspartate aminotransferase&#xD;
             and/or alkaline phosphatase and/or total bilirubin exceeds 1.2 times the upper limit&#xD;
             of normal;&#xD;
&#xD;
         12. Abnormal vital signs (systolic blood pressure &lt;90 mmHg or &gt;140 mmHg, diastolic blood&#xD;
             pressure &lt;50 mmHg or &gt;90 mmHg; pulse &lt;50 bpm or &gt;100 bpm) or physical examination,&#xD;
             electrocardiogram, laboratory examination, imaging examination, etc. Abnormality has&#xD;
             clinical significance (subject to the judgment of the clinical research doctor);&#xD;
&#xD;
         13. The QT interval is prolonged during screening (calculated using Bazett's method,&#xD;
             male&gt;450 msec, female&gt;460 msec);&#xD;
&#xD;
         14. Hepatitis B surface antigen, hepatitis C antibody, syphilis serotonin, HIV antibody&#xD;
             test positive;&#xD;
&#xD;
         15. Women during pregnancy or lactation;&#xD;
&#xD;
         16. Subjects may not be able to complete the study for other reasons or the investigator&#xD;
             believes that they should not be included.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guoping Yang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xiangya Hospital of Central South University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Xiangya Hospital, Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>September 29, 2020</last_update_submitted>
  <last_update_submitted_qc>September 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emtricitabine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04477096
org study id: HS-10234-108
nct id: NCT04477096
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study is being conducted to evaluate drug interaction between HS-10234 and Emtricitabine
      after multiple dose in healthy subjects.
The study includes two parts. Part 1 is to evaluate the impact of Emtricitabine on HS-10234.
      Part 2 is to evaluate the impact of HS-10234 on Emtricitabine.
allocation: N/A
intervention model: Sequential Assignment
primary purpose: Other
masking: None (Open Label)
measure: Pharmacokinetics parameters of HS-10234 and it's metabolite tenofovir, Emtricitabine
time frame: 0 - 24 hour on 7th day
description: Cmax
measure: Pharmacokinetics parameters of HS-10234 and it's metabolite tenofovir, Emtricitabine
time frame: 0 - 24 hour on 7th day
description: AUC0-tau
measure: Concentration of HS-10234's metabolite tenofovir-diphosphate in peripheral blood mononuclear cells.
time frame: 0 - 24 hour on 7th day
description: Concentration
measure: Incidence of AEs,
time frame: 0 - 23 day
description: laboratory abnormalities (based on hematology, biochemistry, and urinalysis tests)
measure: Incidence of AEs,
time frame: 0 - 23 day
description: body temperature
measure: Incidence of AEs,
time frame: 0 - 23 day
description: respiratory rate
measure: Incidence of AEs,
time frame: 0 - 23 day
description: blood pressure
measure: Incidence of AEs,
time frame: 0 - 23 day
description: pulse rate
measure: Incidence of AEs,
time frame: 0 - 23 day
description: Resting 12-lead ECG parameters（ECG QT Interval）
arm group label: single arm for each part: two arms
arm group type: Other
description: PART1:In the first period, HS-10234 will be administered at 25 mg QD for 7 days. In the second period, HS-10234 at 25 mg in combination with Emtricitabine at 200 mg will be administered QD for 7 days.
PART2:In the first period, Emtricitabine will be administered at 200 mg QD for 7 days. In the second period, HS-10234 at 25 mg in combination with Emtricitabine at 200 mg will be administered QD for 7 days.
intervention type: Drug
intervention name: HS-10234
description: HS-10234
arm group label: single arm for each part: two arms
intervention type: Drug
intervention name: Emtricitabine
description: Emtricitabine
arm group label: single arm for each part: two arms
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Guoping Yang
role: Principal Investigator
affiliation: Xiangya Hospital of Central South University
facility: 
country: China
responsible party type: Sponsor
mesh term: Emtricitabine