<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/NCT04476394</url>
  </required_header>
  <id_info>
    <org_study_id>3571-MB-1005</org_study_id>
    <nct_id>NCT04476394</nct_id>
  </id_info>
  <brief_title>Open-label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Oral Dose of [14C]-20 mg/100 μCi Anaprazole Sodium Enteric-coated Capsule in Healthy Adult Male Subjects</brief_title>
  <official_title>A Single-center, Open, Single Dose Mass Balance Study to Assess the Absorption, Metabolism, Excretion of [14C]-20 mg/100 μCi Anaprazole Sodium Enteric-coated Capsule in Chinese Health Adult Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sihuan Pharmaceutical Holdings Group Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sihuan Pharmaceutical Holdings Group 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 an open-label, single-dose, absorption, metabolism, excretion, and mass balance study&#xD;
      following a single oral dose of [14C]-20 mg/100 μCi Anaprazole Sodium enteric-coated capsule&#xD;
      in healthy adult male subjects. Whole blood, plasma samples will be collected at hour 0&#xD;
      pre-dose and 1，2，3，4，5，6，8，12，24，48，72，96，120，144，168 hours post-dose (tentative, adjusted&#xD;
      according to plasma drug concentration); urine samples will be collected at hour 24 pre-dose&#xD;
      and 0-4，4-8，8-12，12-24，24-48，48-72，72-96，96-120，120-144，144-168，168-192，192-216，216-240 hours&#xD;
      post-dose (tentative, adjusted according to sample recovery rate) ; fecal samples will be&#xD;
      collected at hour 24 pre-dose and&#xD;
      0-24，24-48，48-72，72-96，96-120，120-144，144-168，168-192，192-216，216-240 hours post-dose&#xD;
      (tentative, adjusted according to sample recovery rate) following the start of administration&#xD;
      to measure total radioactivity and plasma drug concentrations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 3, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 30, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax of Anaprazole according to total radioactivity concentration equivalents in whole blood and plasma</measure>
    <time_frame>Hour 0 pre-dose and 1，2，3，4，5，6，8，12，24，48，72，96，120，144，168 hours post-dose (tentative, adjusted according to plasma drug concentration)</time_frame>
    <description>Cmax is the peak plasma concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax of Anaprazole according to total radioactivity concentration equivalents in whole blood and plasma</measure>
    <time_frame>Hour 0 pre-dose and 1，2，3，4，5，6，8，12，24，48，72，96，120，144，168 hours post-dose (tentative, adjusted according to plasma drug concentration)</time_frame>
    <description>Tmax is the time to maximum plasma concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC of Anaprazole according to total radioactivity concentration equivalents in whole blood and plasma</measure>
    <time_frame>Hour 0 pre-dose and 1，2，3，4，5，6，8，12，24，48，72，96，120，144，168 hours post-dose (tentative, adjusted according to plasma drug concentration)</time_frame>
    <description>AUC is area under the plasma concentration-time curve</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cumulative excretion and cumulative excretion rate in urine</measure>
    <time_frame>Hour 24 pre-dose and 0-4，4-8，8-12，12-24，24-48，48-72，72-96，96-120，120-144，144-168，168-192，192-216，216-240 hours post-dose (tentative, adjusted according to sample recovery rate)</time_frame>
    <description>Sum of the percent of the total radioactivity recovered in urine relative to the administered radioactivity dose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cumulative excretion and cumulative excretion rate in feces</measure>
    <time_frame>Hour 24 pre-dose and 0-24，24-48，48-72，72-96，96-120，120-144，144-168，168-192，192-216，216-240 hours post-dose (tentative, adjusted according to sample recovery rate)</time_frame>
    <description>Sum of the percent of the total radioactivity recovered in feces relative to the administered radioactivity dose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radioactivity spectrum indentification of metabolites in plasma</measure>
    <time_frame>Hour 0 pre-dose and 1，2，3，4，5，6，8，12，24，48，72，96，120，144，168 hours post-dose (tentative, adjusted according to plasma drug concentration)</time_frame>
    <description>plasma concentration of metabolites</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radioactivity spectrum indentification of metabolites in urine</measure>
    <time_frame>Hour 24 pre-dose and 0-4，4-8，8-12，12-24，24-48，48-72，72-96，96-120，120-144，144-168，168-192，192-216，216-240 hours post-dose (tentative, adjusted according to sample recovery rate)</time_frame>
    <description>Concentration of metabolites in urine</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentration of metabolites in feces</measure>
    <time_frame>Hour 24 pre-dose and 0-24，24-48，48-72，72-96，96-120，120-144，144-168，168-192，192-216，216-240 hours post-dose (tentative, adjusted according to sample recovery rate)</time_frame>
    <description>Sum of the percent of the total radioactivity recovered in feces relative to the administered radioactivity dose</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">6</enrollment>
  <condition>Healthy Male Volunteers</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered orally once</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[14C]-Anaprazole Sodium enteric-coated capsule</intervention_name>
    <description>[14C]-Anaprazole Sodium enteric-coated capsule</description>
    <arm_group_label>1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1.The subject is a Chinese adult male, aged 18 to 45 years, inclusive.&#xD;
&#xD;
          -  2.The subject weighed at least 50.0 kg and had a body mass index (BMI) between 19.0&#xD;
             kg/m^2 and 26.0 kg/m^2, inclusive.&#xD;
&#xD;
          -  3. Participants with evaluations of vital signs, physicial examination&#xD;
             results,clinical laboratory and ECG testing outside the reference range that are&#xD;
             deemed not clinically significant at investigator discretion at screening.&#xD;
&#xD;
          -  4.The subject with childbearing potential agrees that the subject and his sexual&#xD;
             partner use adequate contraception from signing of informed consent throughout the&#xD;
             duration of the study and for 6 months after study completion.&#xD;
&#xD;
          -  5.The subject is capable of understanding and complying with protocol requirements,&#xD;
             and signed and dated a written informed consent form voluntarily&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1.Has clinical significant drug allergy or allergic disease history(Such as asthma,&#xD;
             urticaria, eczema dermatitis, etc), or has hypersensitivity or allergy to&#xD;
             investigatory drugs or related supplements；&#xD;
&#xD;
          -  2.Has clinical significant ECG abnormal history or family history of long QT&#xD;
             syndrome(Grandparents, parents and siblings)&#xD;
&#xD;
          -  3.Any disease or medical history that may significantly affect the absorption,&#xD;
             distribution, metabolism, and excretion of drugs, or any condition that may pose a&#xD;
             hazard to the subject. Such as:&#xD;
&#xD;
               -  Inflammatory bowel disease, gastric ulcer, duodenal ulcer, gastrointestinal /&#xD;
                  rectal bleeding, persistent nausea, or other clinically significant&#xD;
                  gastrointestinal abnormalities;&#xD;
&#xD;
               -  Has suffered from gastrointestinal diseases or complications that may affect the&#xD;
                  absorption of drugs (ie: malabsorption, gastroesophageal reflux, peptic ulcer,&#xD;
                  erosive esophagitis, frequent heartburn) within 6 months before screening or had&#xD;
                  history of gastrointestinal surgery (for example: gastrectomy, gastrointestinal&#xD;
                  anastomosis, intestinal resection, gastric bypass, gastric segmentation or&#xD;
                  gastric banding, cholecystectomy, except for appendicitis surgery and&#xD;
                  proctectomy);&#xD;
&#xD;
               -  Evidence of liver disease or clinically impaired liver function at the time of&#xD;
                  screening (eg AST, ALT or total bilirubin&gt; 1.5 times ULN);&#xD;
&#xD;
               -  A history or evidence of nephropathy or renal insufficiency at the time of&#xD;
                  screening, showing clinically significant abnormality of creatinine or abnormal&#xD;
                  urine composition (such as proteinuria, creatinine&gt; 176.8 umol / L, etc.)&#xD;
&#xD;
               -  Has difficulty swallowing oral preparations.&#xD;
&#xD;
          -  4.Thyroid stimulating hormone (TSH)&gt; ULN; or serum free triiodothyronine (FT3)&gt; ULN;&#xD;
             or serum free thyroxine (FT4)&gt; ULN at the time of screening;&#xD;
&#xD;
          -  5. Frequent smokers and alcoholics within 3 months before screening (smoke more than 5&#xD;
             cigarettes / day, drink more than 21 units of alcohol per week, 1 unit = 360 mL beer&#xD;
             or 45 mL liquor or 150 mL wine), or can't stop using any tobacco products, and alcohol&#xD;
             intake during the study period ; or those who have a positive alcohol breath test&#xD;
             before enrollment;&#xD;
&#xD;
          -  6. Has received any investigational compound (including post-marketing investigational&#xD;
             drugs) or participated in clinical trials of any drugs /devices within 3 months before&#xD;
             screening;&#xD;
&#xD;
          -  7. A history of drug abuse within 12 months before screening or a positive urine test&#xD;
             result at screening;&#xD;
&#xD;
          -  8. Has used any prescription drugs, non-prescription drugs (including chemical drugs,&#xD;
             vitamin drugs, Chinese herbal medicines, etc.) within 4 weeks before administration of&#xD;
             investigational drugs;&#xD;
&#xD;
          -  9. Has taken foods that affect CYP3A4 (such as grapefruit or beverages containing&#xD;
             grapefruit) within 2 weeks before administration of investigational drugs;&#xD;
&#xD;
          -  10. Human immunodeficiency virus antibody, hepatitis B surface antigen, hepatitis C&#xD;
             antibody, and Treponema pallidum specific antibody test results were positive at&#xD;
             screening;&#xD;
&#xD;
          -  11. Has difficulty in venous blood collection or halo acupuncture;&#xD;
&#xD;
          -  12.Blood donation / blood loss ≥200 mL within 1 month, or ≥400 mL within 3 months&#xD;
             before screening; or has blood donation plan during the period of medication of&#xD;
             investigational drugs and within 3 months after drug withdrawal;&#xD;
&#xD;
          -  13. Has special dietary requirements and cannot follow the unified dietary&#xD;
             arrangements;&#xD;
&#xD;
          -  14. Has particpated in another clinical study with radioactive labeling within 1 year&#xD;
             before administration.&#xD;
&#xD;
          -  15. Has significant radiation exposure (Radiation exposure from chest X-ray, CT scan&#xD;
             or barium meal examination more than once, or be engaged in radiation related&#xD;
             occupations) within 1 year before administration.&#xD;
&#xD;
          -  16. Any conditions in which considered by investigator not be appropriate to&#xD;
             participate in this trial.&#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>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04476394
org study id: 3571-MB-1005
nct id: NCT04476394
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study
      following a single oral dose of [14C]-20 mg/100 μCi Anaprazole Sodium enteric-coated capsule
      in healthy adult male subjects. Whole blood, plasma samples will be collected at hour 0
      pre-dose and 1，2，3，4，5，6，8，12，24，48，72，96，120，144，168 hours post-dose (tentative, adjusted
      according to plasma drug concentration); urine samples will be collected at hour 24 pre-dose
      and 0-4，4-8，8-12，12-24，24-48，48-72，72-96，96-120，120-144，144-168，168-192，192-216，216-240 hours
      post-dose (tentative, adjusted according to sample recovery rate) ; fecal samples will be
      collected at hour 24 pre-dose and
      0-24，24-48，48-72，72-96，96-120，120-144，144-168，168-192，192-216，216-240 hours post-dose
      (tentative, adjusted according to sample recovery rate) following the start of administration
      to measure total radioactivity and plasma drug concentrations.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax of Anaprazole according to total radioactivity concentration equivalents in whole blood and plasma
time frame: Hour 0 pre-dose and 1，2，3，4，5，6，8，12，24，48，72，96，120，144，168 hours post-dose (tentative, adjusted according to plasma drug concentration)
description: Cmax is the peak plasma concentration
measure: Tmax of Anaprazole according to total radioactivity concentration equivalents in whole blood and plasma
time frame: Hour 0 pre-dose and 1，2，3，4，5，6，8，12，24，48，72，96，120，144，168 hours post-dose (tentative, adjusted according to plasma drug concentration)
description: Tmax is the time to maximum plasma concentration
measure: AUC of Anaprazole according to total radioactivity concentration equivalents in whole blood and plasma
time frame: Hour 0 pre-dose and 1，2，3，4，5，6，8，12，24，48，72，96，120，144，168 hours post-dose (tentative, adjusted according to plasma drug concentration)
description: AUC is area under the plasma concentration-time curve
measure: Cumulative excretion and cumulative excretion rate in urine
time frame: Hour 24 pre-dose and 0-4，4-8，8-12，12-24，24-48，48-72，72-96，96-120，120-144，144-168，168-192，192-216，216-240 hours post-dose (tentative, adjusted according to sample recovery rate)
description: Sum of the percent of the total radioactivity recovered in urine relative to the administered radioactivity dose
measure: Cumulative excretion and cumulative excretion rate in feces
time frame: Hour 24 pre-dose and 0-24，24-48，48-72，72-96，96-120，120-144，144-168，168-192，192-216，216-240 hours post-dose (tentative, adjusted according to sample recovery rate)
description: Sum of the percent of the total radioactivity recovered in feces relative to the administered radioactivity dose
measure: Radioactivity spectrum indentification of metabolites in plasma
time frame: Hour 0 pre-dose and 1，2，3，4，5，6，8，12，24，48，72，96，120，144，168 hours post-dose (tentative, adjusted according to plasma drug concentration)
description: plasma concentration of metabolites
measure: Radioactivity spectrum indentification of metabolites in urine
time frame: Hour 24 pre-dose and 0-4，4-8，8-12，12-24，24-48，48-72，72-96，96-120，120-144，144-168，168-192，192-216，216-240 hours post-dose (tentative, adjusted according to sample recovery rate)
description: Concentration of metabolites in urine
measure: Concentration of metabolites in feces
time frame: Hour 24 pre-dose and 0-24，24-48，48-72，72-96，96-120，120-144，144-168，168-192，192-216，216-240 hours post-dose (tentative, adjusted according to sample recovery rate)
description: Sum of the percent of the total radioactivity recovered in feces relative to the administered radioactivity dose
arm group label: 1
arm group type: Experimental
description: Administered orally once
intervention type: Drug
intervention name: [14C]-Anaprazole Sodium enteric-coated capsule
description: [14C]-Anaprazole Sodium enteric-coated capsule
arm group label: 1
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor