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/NCT06010680</url>
    </required_header>
    <id_info>
      <org_study_id>SHR2554-I-111</org_study_id>
      <nct_id>NCT06010680</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Mass Balance of [14C]SHR2554 in Healthy Adult Volunteers</brief_title>
    <official_title>Phase I Clinical Trial of Substance Balance of [14C]SHR2554 in Healthy Chinese Subjects</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>
        Evaluate the Mass Balance of [14C]SHR2554 in Healthy Adult Male Volunteers.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">October 3, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 26, 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>
      <intervention_model_description>Single oral dose of [14C]SHR2554</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cumulative recovery and recovery rate of total radioactive substance in urine and feces</measure>
      <time_frame>0-288 hours</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC)</measure>
      <time_frame>0-240 hours</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of parent drug and its metabolites in urine and feces as a percentage of administered dose (%Dose)</measure>
      <time_frame>0-288 hours</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Radioactivity Tmax</measure>
      <time_frame>0-240 hours</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Radioactivity Cmax</measure>
      <time_frame>0-240 hours</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Radioactivity AUC</measure>
      <time_frame>0-240 hours</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Radioactivity t1/2</measure>
      <time_frame>0-240 hours</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Radioactivity CL/F</measure>
      <time_frame>0-240 hours</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Radioactivity Vz/F</measure>
      <time_frame>0-240 hours</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>1Total radioactivity ratio for blood/plasma</measure>
      <time_frame>0-72 hours</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Plasma SHR2554: Tmax</measure>
      <time_frame>0-240 hours</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma SHR2554: Cmax</measure>
      <time_frame>0-240 hours</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma SHR2554: AUC</measure>
      <time_frame>0-240 hours</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma SHR2554: t1/2</measure>
      <time_frame>0-240 hours</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma SHR2554: CL/F</measure>
      <time_frame>0-240 hours</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma SHR2554: Vz/F</measure>
      <time_frame>0-240 hours</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma SHR2554: λz</measure>
      <time_frame>0-240 hours</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AEs and SAEs</measure>
      <time_frame>0-12 days</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">8</enrollment>
    <condition>Lymphoma</condition>
    <arm_group>
      <arm_group_label>[14C]SHR2554</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>[14C]SHR2554</intervention_name>
      <description>Patients will receive single dose of orally [14C]SHR2554 on Day 1.</description>
      <arm_group_label>[14C]SHR2554</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Healthy adult males between 18 and 45 years;&#xD;
  &#xD;
            2. Total Body weight ≥50 kg, and the body mass index (BMI) of 19 to 26 kg/m2;&#xD;
  &#xD;
            3. Sign the informed consent form prior to the trial and have a full understanding of the&#xD;
               trial's procedures, content, and potential adverse reactions;&#xD;
  &#xD;
            4. Ability to communicate effectively with the researchers and comply with the trial&#xD;
               requirements.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Comprehensive physical examination, vital signs, laboratory tests, 12-lead ECG, chest&#xD;
               X-ray (posteroanterior), anal digital examination, abdominal ultrasound with&#xD;
               clinically significant abnormalities as determined by the investigator;&#xD;
  &#xD;
            2. Resting corrected QT interval (QTcF) &gt;450 ms as obtained from the 12-lead ECG (Note:&#xD;
               QTcF interval must be calculated according to Fridericia's method);&#xD;
  &#xD;
            3. Positive results in any of the following tests: hepatitis B surface antigen or&#xD;
               hepatitis B e antigen, hepatitis C virus antibodies or HIV antigen/antibody&#xD;
               combination test (HIV-Ag/Ab);&#xD;
  &#xD;
            4. Clinically significant abnormalities in ophthalmic examination (slit lamp, intraocular&#xD;
               pressure, and fundus photography);&#xD;
  &#xD;
            5. Have taken any clinical trial drug or participated in any clinical trial within 3&#xD;
               months before administration;&#xD;
  &#xD;
            6. CYP3A4 inducers or inhibitors were taken within 30 days before administration;&#xD;
  &#xD;
            7. Have taken any prescription or over-the-counter drugs, vitamin products, health care&#xD;
               drugs or traditional Chinese medicines within 14 days before administration;&#xD;
  &#xD;
            8. History of any clinically significant medical conditions or conditions that the&#xD;
               investigator deems may affect the trial results, including but not limited to&#xD;
               cardiovascular, respiratory, endocrine, nervous, digestive, urinary, immune, mental,&#xD;
               and metabolic diseases;&#xD;
  &#xD;
            9. History of organic heart disease, congestive heart failure, myocardial infarction,&#xD;
               angina pectoris, unexplained history of arrhythmia, history of torsades de pointes,&#xD;
               history of ventricular tachycardia, atrioventricular conduction block, history of QT&#xD;
               prolongation syndrome, or family history of QT prolongation syndrome (confirmed by&#xD;
               genetic testing or sudden cardiac death in a close relative at a young age due to&#xD;
               cardiac reasons);&#xD;
  &#xD;
           10. Those who have undergone major surgery within 6 months before administration or that&#xD;
               surgical incision has not completely healed; Major surgery includes, but is not&#xD;
               limited to, any surgery that is at significant risk of bleeding, prolongs the period&#xD;
               of general anesthesia, or has an incision biopsy or significant traumatic injury;&#xD;
  &#xD;
           11. Hemorrhoids or anal diseases accompanied by regular/ongoing rectal bleeding; inability&#xD;
               to swallow or a history of gastrointestinal dysfunction such as irritable bowel&#xD;
               syndrome, inflammatory bowel disease, or previous gastric resection surgery that may&#xD;
               affect drug absorption as determined by the investigator;&#xD;
  &#xD;
           12. Allergic predisposition, such as known history of allergy to two or more substances;&#xD;
               or deemed by the investigator to be potentially allergic to the investigational drug&#xD;
               or its excipients;&#xD;
  &#xD;
           13. Habitual constipation or diarrhea;&#xD;
  &#xD;
           14. History of alcoholism with alcohol consumption over 14 units per week; and can't&#xD;
               abstain from smoking and alcohol during the study;&#xD;
  &#xD;
           15. Heavy smoker or habitually use nicotine-containing products;&#xD;
  &#xD;
           16. Have a history of drug abuse or have used soft drugs (such as: marijuana) within 3&#xD;
               months before administration or take drugs (such as cocaine, amphetamines,&#xD;
               phencyclidine, etc.) within 1 year before administration; or positive urine drug abuse&#xD;
               test during screening periods;&#xD;
  &#xD;
           17. Habitual consumption of grapefruit juice or excessive tea, coffee and/or caffeinated&#xD;
               beverages (more than 8 cups a day, 1 cup = 250 mL) and unable to quit during the study&#xD;
               period;&#xD;
  &#xD;
           18. Those who cannot tolerate venipuncture or with a history of needle-sickness and&#xD;
               blood-sickness;&#xD;
  &#xD;
           19. Workers who require long-term exposure to radioactive conditions; or those who have&#xD;
               significant radiation exposure (≥ 2 chest/abdominal CT scans, or ≥3 other X-ray tests)&#xD;
               within 1 year prior to administration or who have participated in radiopharmaceutical&#xD;
               labeling tests;&#xD;
  &#xD;
           20. Blood donation no less than 400 mL or have blood transfusion within 3 months of&#xD;
               dosing;&#xD;
  &#xD;
           21. Vaccination within one month prior to screening or planning to be vaccinated during&#xD;
               the trial;&#xD;
  &#xD;
           22. Intention to conceive or donate sperm during the trial period or within one year after&#xD;
               completing the trial, or refusal to strictly adhere to contraceptive measures by the&#xD;
               participant and their spouse/partner from the time of signing the informed consent&#xD;
               form until one year after completing the trial;&#xD;
  &#xD;
           23. Subjects who, in the opinion of the Investigator should not participate in this 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_contact>
      <last_name>FEN YAO</last_name>
      <phone>0518-82342973</phone>
      <email>fen.yao.fy3@hengrui.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>ZHENYU ZHU</last_name>
      <phone>0518-82342973</phone>
      <email>zhenyu.zhu@hengrui.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 20, 2023</last_update_submitted>
    <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 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/NCT06010680
  org study id: SHR2554-I-111
  nct id: NCT06010680
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Evaluate the Mass Balance of [14C]SHR2554 in Healthy Adult Male Volunteers.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Single oral dose of [14C]SHR2554
  primary purpose: Other
  masking: None (Open Label)
  measure: Cumulative recovery and recovery rate of total radioactive substance in urine and feces
  time frame: 0-288 hours
  measure: Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC)
  time frame: 0-240 hours
  measure: Percentage of parent drug and its metabolites in urine and feces as a percentage of administered dose (%Dose)
  time frame: 0-288 hours
  measure: Radioactivity Tmax
  time frame: 0-240 hours
  measure: Radioactivity Cmax
  time frame: 0-240 hours
  measure: Radioactivity AUC
  time frame: 0-240 hours
  measure: Radioactivity t1/2
  time frame: 0-240 hours
  measure: Radioactivity CL/F
  time frame: 0-240 hours
  measure: Radioactivity Vz/F
  time frame: 0-240 hours
  measure: 1Total radioactivity ratio for blood/plasma
  time frame: 0-72 hours
  measure: Plasma SHR2554: Tmax
  time frame: 0-240 hours
  measure: Plasma SHR2554: Cmax
  time frame: 0-240 hours
  measure: Plasma SHR2554: AUC
  time frame: 0-240 hours
  measure: Plasma SHR2554: t1/2
  time frame: 0-240 hours
  measure: Plasma SHR2554: CL/F
  time frame: 0-240 hours
  measure: Plasma SHR2554: Vz/F
  time frame: 0-240 hours
  measure: Plasma SHR2554: λz
  time frame: 0-240 hours
  measure: AEs and SAEs
  time frame: 0-12 days
  arm group label: [14C]SHR2554
  arm group type: Experimental
  intervention type: Drug
  intervention name: [14C]SHR2554
  description: Patients will receive single dose of orally [14C]SHR2554 on Day 1.
  arm group label: [14C]SHR2554
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: FEN YAO
  phone: 0518-82342973
  email: fen.yao.fy3@hengrui.com
  last name: ZHENYU ZHU
  phone: 0518-82342973
  email: zhenyu.zhu@hengrui.com
  responsible party type: Sponsor
  sharing ipd: Undecided