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/NCT06035406</url>
    </required_header>
    <id_info>
      <org_study_id>SP2086-117</org_study_id>
      <nct_id>NCT06035406</nct_id>
    </id_info>
    <brief_title>A Trial of SP2086 With Hepatic Insufficiency</brief_title>
    <official_title>Pharmacokinetics and Safety of SP2086 in Subjects With Mild and Moderate Liver Impairment and Normal Liver Function.</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>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study used a single-dose, open design to compare the pharmacokinetics of subjects with&#xD;
        mild and moderate liver impairment and subjects with normal liver function.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>PK parameters：Cmax；</measure>
      <time_frame>0hour to 72hours after the last dosing</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>PK parameters：AUC0-t；</measure>
      <time_frame>0hour to 72hours after the last dosing</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>PK parameters：AUC0-∞；</measure>
      <time_frame>0hour to 72hours after the last dosing</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>PK parameters：Tmax；</measure>
      <time_frame>0hour to 72hours after the last dosing</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK parameters：t1/2；</measure>
      <time_frame>0hour to 72hours after the last dosing</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK parameters：CL/F；</measure>
      <time_frame>0hour to 72hours after the last dosing</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK parameters：V/F；</measure>
      <time_frame>0hour to 72hours after the last dosing</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence and severity of adverse events (AEs)</measure>
      <time_frame>from screening to 168 hours after the last dosing</time_frame>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Diabetes</condition>
    <arm_group>
      <arm_group_label>Treatment group A: Retagliptin Phosphate Tablet</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment group B: Retagliptin Phosphate Tablet</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment group C: Retagliptin Phosphate Tablet</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Retagliptin Phosphate Tablet</intervention_name>
      <description>Retagliptin Phosphate Tablet;100mg</description>
      <arm_group_label>Treatment group A: Retagliptin Phosphate Tablet</arm_group_label>
      <arm_group_label>Treatment group B: Retagliptin Phosphate Tablet</arm_group_label>
      <arm_group_label>Treatment group C: Retagliptin Phosphate Tablet</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Sign informed consent before the test, and fully understand the test content, process&#xD;
               and possible adverse reactions; And be able to complete the research according to the&#xD;
               requirements of the test plan;&#xD;
  &#xD;
            2. The subjects (including their partners) are willing to voluntarily take effective&#xD;
               contraceptive measures from screening until 2 weeks after the last study drug&#xD;
               administration, as specified in Appendix 1;&#xD;
  &#xD;
            3. Age 18-70 years old (including the critical value), both male and female;&#xD;
  &#xD;
            4. The weight of male subjects is not less than 50 kg, and the weight of female subjects&#xD;
               is not less than 45 kg. Body mass index (BMI) : 18-32 kg/m2 (including the cut-off&#xD;
               value);&#xD;
  &#xD;
            5. (Only for subjects with normal liver function) The demographic mean of subjects in the&#xD;
               normal liver function group (Group C) at screening must meet the following matching&#xD;
               criteria:&#xD;
  &#xD;
                 1. The body weight was matched with that of the liver function impairment group&#xD;
                    (group A + group B), with an average of ±10 kg;&#xD;
  &#xD;
                 2. Age matching was performed with the liver function impairment group (group A +&#xD;
                    group B), and the mean was ±10 years old;&#xD;
  &#xD;
                 3. Gender matching was performed with the liver function impairment group (group A +&#xD;
                    group B), with an average of ±1 cases;&#xD;
  &#xD;
            6. (Only for subjects with normal liver function) Normal or abnormal clinical laboratory&#xD;
               tests (blood routine, blood biochemistry, urine routine, coagulation function) have no&#xD;
               clinical significance.&#xD;
  &#xD;
            7. (Only for subjects with normal liver function) No prior serious primary diseases of&#xD;
               major organs, including but not limited to gastrointestinal, respiratory, kidney,&#xD;
               liver, nervous, blood, endocrine, tumor, immune, psychiatric or cardiovascular and&#xD;
               cerebrovascular diseases&#xD;
  &#xD;
            8. (Only for subjects with liver function impairment) Those who had not taken medication&#xD;
               within 4 weeks prior to screening, or who had at least 4 weeks of stable medication&#xD;
               for liver impairment and/or other comorbidification requiring long-term treatment&#xD;
  &#xD;
            9. (Only for subjects with liver function impairment) Patients with liver insufficiency&#xD;
               due to previous primary liver disease with Child-Pugh grade A or B.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. allergy, or known or suspected allergy to any of the ingredients in the&#xD;
               investigational drug;&#xD;
  &#xD;
            2. Smoking an average of more than 10 cigarettes per day in the 3 months before&#xD;
               screening;&#xD;
  &#xD;
            3. Alcoholics in the preceding 3 months, i.e. drinking more than 14 units of alcohol per&#xD;
               week (1 unit = 285 mL for beer, 25 mL for spirits, or 100 ml for wine);&#xD;
  &#xD;
            4. Drug abusers or drug urine screening test positive;&#xD;
  &#xD;
            5. Blood donation or blood loss ≥400 mL within 3 months before screening, or receiving&#xD;
               blood transfusion;&#xD;
  &#xD;
            6. Major surgery or surgical incision not fully healed within 6 months prior to&#xD;
               screening;&#xD;
  &#xD;
            7. Had been exposed to DPP-IV inhibitors such as sitagliptin, saxagliptin, ligagliptin,&#xD;
               vigagliptin within 1 month prior to administration;&#xD;
  &#xD;
            8. Chinese herbal medicine was taken within 2 weeks before administration;&#xD;
  &#xD;
            9. Have malignant tumors, or a history of malignant tumors within 5 years prior to&#xD;
               screening (except for treated non-melanoma skin tumors with no signs of recurrence,&#xD;
               and resected cervical intraepithelial neoplasia);&#xD;
  &#xD;
           10. Patients with a history of severe hypoglycemia;&#xD;
  &#xD;
           11. History of recurrent urinary tract infections or/and genital fungal infections;&#xD;
  &#xD;
           12. Those who are expected to have a tendency to undergo surgery or be hospitalized during&#xD;
               the trial;&#xD;
  &#xD;
           13. Systolic blood pressure &gt; 160 mmHg or diastolic blood pressure &gt; 100 mmHg at the time&#xD;
               of screening;&#xD;
  &#xD;
           14. 14.12- Patients with clinically significant ECG abnormalities (such as&#xD;
               tachycardia/bradycardia requiring medical treatment, degree II-III atrioventricular&#xD;
               block, or QTcF (male) ≥470ms, QTcF (female) ≥480ms), or other clinically significant&#xD;
               abnormalities determined by the investigator and judged by the investigator to be&#xD;
               unsuitable for participation in this study;&#xD;
  &#xD;
           15. Female subjects were breastfeeding or had positive pregnancy results during the&#xD;
               screening period or during the test;&#xD;
  &#xD;
           16. 16. Serum creatinine values were estimated glomerular filtration rate calculated using&#xD;
               the chronic kidney disease epidemiology collaboration CKD-EPI formula filtration rate&#xD;
               eGFR) &lt; 90 ml/min;&#xD;
  &#xD;
           17. 17. Anyone who has consumed any food or drink containing alcohol (or positive breath&#xD;
               test for alcohol), grapefruit juice/grapefruit juice, methylxanthine (such as coffee,&#xD;
               tea, cola, chocolate, energy drinks), strenuous exercise or other factors affecting&#xD;
               drug absorption, distribution, metabolism, excretion or other factors within 2 days&#xD;
               prior to administration;&#xD;
  &#xD;
           18. 18 Those who had any factors deemed inappropriate by the investigator to participate&#xD;
               in the study.&#xD;
  &#xD;
           19. (Only for subjects with normal liver function) Participants who have participated in&#xD;
               clinical trials of any drug or medical device within 3 months prior to screening&#xD;
               (subject to acceptance of the drug)&#xD;
  &#xD;
           20. (Only for subjects with normal liver function) Hepatitis B surface antigen, hepatitis&#xD;
               C virus antibody, human immunodeficiency virus antibody or syphilis antibody detection&#xD;
               of any index screening positive excluded.&#xD;
  &#xD;
           21. (Only for subjects with liver function impairment) Participants who have participated&#xD;
               in clinical trials of any drug or medical device within 1 month prior to screening&#xD;
               (subject to acceptance of the drug)&#xD;
  &#xD;
           22. (Only for subjects with liver function impairment) A history of liver transplantation&#xD;
  &#xD;
           23. (Only for subjects with liver function impairment) Subjects with liver failure, or&#xD;
               liver cirrhosis with complications such as hepatic encephalopathy, hepatocellular&#xD;
               carcinoma, esophageal variceal hemorrhage and other complications deemed inappropriate&#xD;
               by the researchers to participate in the study&#xD;
  &#xD;
           24. (Only for subjects with liver function impairment) In addition to the primary liver&#xD;
               disease itself, a history of any serious disease, or a medical history or&#xD;
               abnormalities that the investigator believes may affect the results of the trial,&#xD;
               and/or clinically significant clinical laboratory tests, including, but not limited&#xD;
               to, a history of circulatory, endocrine, nervous, digestive, urinary, or blood,&#xD;
               immune, psychiatric, and metabolic disorders.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Sheng Feng</last_name>
      <phone>+86-0518-82342973</phone>
      <email>sheng.feng@hengrui.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Xihan Wang</last_name>
      <phone>+86-0518-82342973</phone>
      <email>xihan.wang@hengrui.com</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06035406
  org study id: SP2086-117
  nct id: NCT06035406
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study used a single-dose, open design to compare the pharmacokinetics of subjects with
        mild and moderate liver impairment and subjects with normal liver function.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: PK parameters：Cmax；
  time frame: 0hour to 72hours after the last dosing
  measure: PK parameters：AUC0-t；
  time frame: 0hour to 72hours after the last dosing
  measure: PK parameters：AUC0-∞；
  time frame: 0hour to 72hours after the last dosing
  measure: PK parameters：Tmax；
  time frame: 0hour to 72hours after the last dosing
  measure: PK parameters：t1/2；
  time frame: 0hour to 72hours after the last dosing
  measure: PK parameters：CL/F；
  time frame: 0hour to 72hours after the last dosing
  measure: PK parameters：V/F；
  time frame: 0hour to 72hours after the last dosing
  measure: Incidence and severity of adverse events (AEs)
  time frame: from screening to 168 hours after the last dosing
  arm group label: Treatment group A: Retagliptin Phosphate Tablet
  arm group type: Experimental
  arm group label: Treatment group B: Retagliptin Phosphate Tablet
  arm group type: Experimental
  arm group label: Treatment group C: Retagliptin Phosphate Tablet
  arm group type: Experimental
  intervention type: Drug
  intervention name: Retagliptin Phosphate Tablet
  description: Retagliptin Phosphate Tablet;100mg
  arm group label: Treatment group A: Retagliptin Phosphate Tablet
  arm group label: Treatment group B: Retagliptin Phosphate Tablet
  arm group label: Treatment group C: Retagliptin Phosphate Tablet
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sheng Feng
  phone: +86-0518-82342973
  email: sheng.feng@hengrui.com
  last name: Xihan Wang
  phone: +86-0518-82342973
  email: xihan.wang@hengrui.com
  responsible party type: Sponsor
  sharing ipd: Undecided