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/NCT05998304</url>
    </required_header>
    <id_info>
      <org_study_id>HEC110114-HCV-103/CRC-C2314</org_study_id>
      <nct_id>NCT05998304</nct_id>
    </id_info>
    <brief_title>ADME Study of [14C] Yiqibuvir in Healthy Male Subjects</brief_title>
    <official_title>Single Dose Absorption, Distribution, Metabolism, and Excretion Study of [14C] Yiqibuvir in Healthy Male Participants</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sunshine Lake Pharma Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sunshine Lake Pharma 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-centre, open-label, mass balance and biotransformation study in healthy male&#xD;
        subjects utilising a single oral dose of [14C] Yiqibuvir.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 10, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cumulative excretion of [14C] Yiqibuvir -related material (radioactivity in plasma, urine and fecal samples)</measure>
      <time_frame>up to 18 days</time_frame>
      <description>Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Identification of the Proportion of different metabolites to determine biotransformation pathway of Yiqibuvir</measure>
      <time_frame>up to 18 days</time_frame>
      <description>Proportion of different metabolites(Yiqibuvir and main metabolites）</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quantitive analysis of the concentrations of Yiqibuvir and main metabolites in plasma using the validated LC-MS/MS to obtain pharmacokinetic data</measure>
      <time_frame>up to 18 days</time_frame>
      <description>The concentrations of Yiqibuvir and main metabolites in plasma</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of adverse events (AE) experienced by subjects</measure>
      <time_frame>up to 18 days</time_frame>
      <description>To examine the safety and tolerability of [14C] Yiqibuvir given orally</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">8</enrollment>
    <condition>Healthy Male Subjects</condition>
    <arm_group>
      <arm_group_label>[14C] Yiqibuvir</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Eligible healthy male subjects received a single oral 600 mg (radioactivity of 100µCi) dose of [14C] Yiqibuvir</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>[14C] Yiqibuvir</intervention_name>
      <description>600 mg suspension containing 100µCi of [14C] Yiqibuvir</description>
      <arm_group_label>[14C] Yiqibuvir</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  signing of informed consent&#xD;
  &#xD;
            -  Weight: Body mass index (BMI) is 19.0~28.0 kg/m2&#xD;
  &#xD;
            -  Subjects are able to communicate well with the investigators and be able to complete&#xD;
               the trial according to the process&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those who are known to have allergy history or allergy constitution to the test&#xD;
               preparation and any of its components or related preparations&#xD;
  &#xD;
            -  Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive&#xD;
               test for HIV, Treponema pallidum antibody positive&#xD;
  &#xD;
            -  Positive results from urine drug screen test&#xD;
  &#xD;
            -  Donate blood or lose blood 400 mL or more within 3 month prior to dosing&#xD;
  &#xD;
            -  Subjects who have used any medication, biological product, Chinese patent medicine,&#xD;
               herbal medicine, nutritional supplements or health care products within 14 days prior&#xD;
               to the first dose of study medication, or participated in other clinical studies or&#xD;
               participated in a clinical study of test preparation within 3 months prior to the&#xD;
               first dose of study medication&#xD;
  &#xD;
            -  History of needles or blood fainting, or have difficulty in blood collection or cannot&#xD;
               tolerate venipuncture for blood collection&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>YanMei Liu, Doctor</last_name>
      <phone>021-54030254</phone>
      <email>ymliu@shxh-centerlab.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Shanghai xuhui central hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>yanmei Liu</last_name>
        <phone>021-54030254</phone>
        <email>ymliu@shxh-centerlab.com</email>
      </contact>
      <contact_backup>
        <last_name>gangyi Liu</last_name>
        <phone>18821146094</phone>
        <email>gyliu@shxh-centerlab.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05998304
  org study id: HEC110114-HCV-103/CRC-C2314
  nct id: NCT05998304
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a single-centre, open-label, mass balance and biotransformation study in healthy male
        subjects utilising a single oral dose of [14C] Yiqibuvir.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Cumulative excretion of [14C] Yiqibuvir -related material (radioactivity in plasma, urine and fecal samples)
  time frame: up to 18 days
  description: Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces.
  measure: Identification of the Proportion of different metabolites to determine biotransformation pathway of Yiqibuvir
  time frame: up to 18 days
  description: Proportion of different metabolites(Yiqibuvir and main metabolites）
  measure: Quantitive analysis of the concentrations of Yiqibuvir and main metabolites in plasma using the validated LC-MS/MS to obtain pharmacokinetic data
  time frame: up to 18 days
  description: The concentrations of Yiqibuvir and main metabolites in plasma
  measure: Number of adverse events (AE) experienced by subjects
  time frame: up to 18 days
  description: To examine the safety and tolerability of [14C] Yiqibuvir given orally
  arm group label: [14C] Yiqibuvir
  arm group type: Experimental
  description: Eligible healthy male subjects received a single oral 600 mg (radioactivity of 100µCi) dose of [14C] Yiqibuvir
  intervention type: Drug
  intervention name: [14C] Yiqibuvir
  description: 600 mg suspension containing 100µCi of [14C] Yiqibuvir
  arm group label: [14C] Yiqibuvir
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: YanMei Liu, Doctor
  phone: 021-54030254
  email: ymliu@shxh-centerlab.com
  facility: 
  contact: 
  contact backup: 
  country: China
  responsible party type: Sponsor
  sharing ipd: No