<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/NCT03748745</url>
  </required_header>
  <id_info>
    <org_study_id>SHC005-I-04</org_study_id>
    <nct_id>NCT03748745</nct_id>
  </id_info>
  <brief_title>A Drug-drug Interaction Study of SH229 Tablets and Daclatasvir Dihydrochloride Tablets in Healthy Subjects</brief_title>
  <official_title>A Single-center, Open-label, Steady-state Drug-drug Interaction Study of SH229 Tablets and Daclatasvir Dihydrochloride Tablets in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanjing Sanhome Pharmaceutical, Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing Sanhome Pharmaceutical, 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 purpose of this study is to evaluate the drug-drug interaction of SH229 tablets and&#xD;
      Daclatasvir dihydrochloride tablets. The study also evaluates the pharmacokinetics and&#xD;
      tolerability of co-administration of SH229 tablets and Daclatasvir dihydrochloride tablets in&#xD;
      healthy subjects. This study provides evidence for the designing of following clinical trial&#xD;
      protocols.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 28 evaluable healthy subjects will be enrolled in this study. The dose of SH229 is&#xD;
      600 mg. The dose of Daclatasvir dihydrochloride is 60 mg.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 19, 2018</start_date>
  <completion_date type="Actual">December 25, 2018</completion_date>
  <primary_completion_date type="Actual">December 25, 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Up to 1 month after last dose</time_frame>
    <description>Cohort A and Cohort B [Safety and tolerability]</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tmax, ss</measure>
    <time_frame>Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose</time_frame>
    <description>Time of maximum observed concentration; safety and validity criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax, ss</measure>
    <time_frame>Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose</time_frame>
    <description>Maximum observed concentration; safety and validity criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmin, ss</measure>
    <time_frame>Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose</time_frame>
    <description>Minimum observed concentration; safety and validity criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2, ss</measure>
    <time_frame>Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose</time_frame>
    <description>Elimination half-life; safety and validity criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-24, ss</measure>
    <time_frame>Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose</time_frame>
    <description>Area under the concentration-time curve (AUC) from time 0 to 24 hours; safety and validity criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-72, ss</measure>
    <time_frame>Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose</time_frame>
    <description>Area under the concentration-time curve (AUC) from time 0 to 72 hours; safety and validity criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-∞, ss</measure>
    <time_frame>Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose</time_frame>
    <description>Area under the concentration-time curve (AUC) from time 0 to infinity; safety and validity criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F ss</measure>
    <time_frame>Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose</time_frame>
    <description>Apparent clearance; safety and validity criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DF</measure>
    <time_frame>Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose</time_frame>
    <description>Degree of fluctuation; safety and validity criteria</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Drug Interactions</condition>
  <arm_group>
    <arm_group_label>Cohort A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SH229 (600 mg) once daily, Daclatasvir dihydrochloride (60 mg) once daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SH229 (600 mg) once daily, Daclatasvir dihydrochloride (60 mg) once daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SH229</intervention_name>
    <description>tablet, oral, 600 mg once daily for day 1 to day 14</description>
    <arm_group_label>Cohort A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SH229</intervention_name>
    <description>tablet, oral, 600 mg once daily for day 8 to day 14</description>
    <arm_group_label>Cohort B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daclatasvir dihydrochloride</intervention_name>
    <description>tablet, oral, 60 mg once daily for day 8 to day 14</description>
    <arm_group_label>Cohort A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daclatasvir dihydrochloride</intervention_name>
    <description>tablet, oral, 60 mg once daily for day 1 to day 14</description>
    <arm_group_label>Cohort B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Sign the informed consent form before the study and fully understand the study&#xD;
             content, process and possible adverse reactions;&#xD;
&#xD;
          2. Be able to complete the study as required by the protocol;&#xD;
&#xD;
          3. Subjects (including their partners) who are willing to voluntarily take effective&#xD;
             contraceptive measures from screening to 6 months after the last dose. See the&#xD;
             appendix for specific contraceptive measures;&#xD;
&#xD;
          4. Male subjects aged 18-45 (including 18 and 45 years old);&#xD;
&#xD;
          5. Male subjects who weigh no less than 50 kg and have a body mass index between 18 and&#xD;
             28 kg / m2 (including the threshold). Body mass index (BMI) = weight (kg) / height2&#xD;
             (m2);&#xD;
&#xD;
          6. Physical examination and vital signs normal, or the abnormal signs have no clinical&#xD;
             significance.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Smoke more than 5 cigarettes per day within three months prior to study;&#xD;
&#xD;
          2. Subjects who are allergic to the study drugs or prone to allergies (Multiple drug and&#xD;
             food allergies);&#xD;
&#xD;
          3. Subjects with history of drug and/or alcohol abuse (14 units per week: 1 unit = 285 mL&#xD;
             of beer, or 25 mL of hard liquor, or 100 mL of wine);&#xD;
&#xD;
          4. Subjects with history of blood donation or massive blood loss (&gt; 450 mL) within three&#xD;
             months prior to screening;&#xD;
&#xD;
          5. Subjects with dysphagia or have history of gastrointestinal disorders which affects&#xD;
             study drug absorption;&#xD;
&#xD;
          6. Subjects with any diseases that increase the risk of bleeding, such as hemorrhoids,&#xD;
             acute gastritis, or gastric and duodenal ulcers;&#xD;
&#xD;
          7. Use of any drugs that alter liver enzyme activity within 28 days prior to screening;&#xD;
&#xD;
          8. Use of any prescription drugs, over-the-counter drugs, vitamin products or herbal&#xD;
             medicines within 14 days prior to screening;&#xD;
&#xD;
          9. Use of special diet (including dragon fruit, mango, grapefruit, etc.), strenuous&#xD;
             activities or other factors that may affect the absorption, distribution, metabolism&#xD;
             and excretion of the study drug within 2 weeks prior to screening;&#xD;
&#xD;
         10. Concomitant use of strong inhibitors or inducers of CYP3A4, P-gp or Bcrp, such as&#xD;
             itraconazole, ketoconazole or dronedarone;&#xD;
&#xD;
         11. Subjects with major changes in diet or exercise habits recently;&#xD;
&#xD;
         12. Use of study drugs or participation in other clinical trials within three months prior&#xD;
             to dosing;&#xD;
&#xD;
         13. Subjects who have ECG abnormalities with clinical significance;&#xD;
&#xD;
         14. Subjects who have abnormalities with clinical significant in clinical laboratory tests&#xD;
             or other clinical findings that indicate clinically significant diseases (including&#xD;
             but not limited to gastrointestinal, renal, hepatic, neurologic, hematologic,&#xD;
             endocrine, oncologic, pulmonary, immunologic, psychiatric or cardiovascular diseases);&#xD;
&#xD;
         15. Subjects with viral hepatitis (including hepatitis B and hepatitis C), AIDS antibody&#xD;
             and/or antibody screening positive for Treponema pallidum;&#xD;
&#xD;
         16. Subjects with acute disease or concomitant use of drugs from screening stage to&#xD;
             dosing;&#xD;
&#xD;
         17. Use of chocolate, food or beverages containing caffeine or xanthine within 24 hours&#xD;
             prior to dosing;&#xD;
&#xD;
         18. Use of products containing alcohol within 24 hours prior to dosing;&#xD;
&#xD;
         19. Subjects with urine drug screening test positive, or with history of drug abuse in the&#xD;
             past 5 years;&#xD;
&#xD;
         20. Subjects with any other reasons that investigator considers to be unsuitable for the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yanhua Ding, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Phase I Clinical Trial Unit, The First Hospital of Jilin University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Phase I Clinical Trial Unit, The First Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 2, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>August 12, 2019</last_update_submitted>
  <last_update_submitted_qc>August 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HCV</keyword>
  <keyword>SH229</keyword>
  <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/NCT03748745
org study id: SHC005-I-04
nct id: NCT03748745
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the drug-drug interaction of SH229 tablets and
      Daclatasvir dihydrochloride tablets. The study also evaluates the pharmacokinetics and
      tolerability of co-administration of SH229 tablets and Daclatasvir dihydrochloride tablets in
      healthy subjects. This study provides evidence for the designing of following clinical trial
      protocols.
A total of 28 evaluable healthy subjects will be enrolled in this study. The dose of SH229 is
      600 mg. The dose of Daclatasvir dihydrochloride is 60 mg.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of adverse events
time frame: Up to 1 month after last dose
description: Cohort A and Cohort B [Safety and tolerability]
measure: Tmax, ss
time frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
description: Time of maximum observed concentration; safety and validity criteria
measure: Cmax, ss
time frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
description: Maximum observed concentration; safety and validity criteria
measure: Cmin, ss
time frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
description: Minimum observed concentration; safety and validity criteria
measure: t1/2, ss
time frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
description: Elimination half-life; safety and validity criteria
measure: AUC0-24, ss
time frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
description: Area under the concentration-time curve (AUC) from time 0 to 24 hours; safety and validity criteria
measure: AUC0-72, ss
time frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
description: Area under the concentration-time curve (AUC) from time 0 to 72 hours; safety and validity criteria
measure: AUC0-∞, ss
time frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
description: Area under the concentration-time curve (AUC) from time 0 to infinity; safety and validity criteria
measure: CL/F ss
time frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
description: Apparent clearance; safety and validity criteria
measure: DF
time frame: Day 5, 6, 7, 8, 12, 13, 14, 15, 16, 17 after first dose
description: Degree of fluctuation; safety and validity criteria
arm group label: Cohort A
arm group type: Experimental
description: SH229 (600 mg) once daily, Daclatasvir dihydrochloride (60 mg) once daily.
arm group label: Cohort B
arm group type: Experimental
description: SH229 (600 mg) once daily, Daclatasvir dihydrochloride (60 mg) once daily.
intervention type: Drug
intervention name: SH229
description: tablet, oral, 600 mg once daily for day 1 to day 14
arm group label: Cohort A
intervention type: Drug
intervention name: SH229
description: tablet, oral, 600 mg once daily for day 8 to day 14
arm group label: Cohort B
intervention type: Drug
intervention name: Daclatasvir dihydrochloride
description: tablet, oral, 60 mg once daily for day 8 to day 14
arm group label: Cohort A
intervention type: Drug
intervention name: Daclatasvir dihydrochloride
description: tablet, oral, 60 mg once daily for day 1 to day 14
arm group label: Cohort B
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yanhua Ding, MD
role: Principal Investigator
affiliation: Phase I Clinical Trial Unit, The First Hospital of Jilin University
facility: 
country: China
responsible party type: Sponsor
sharing ipd: No