<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/NCT04441450</url>
  </required_header>
  <id_info>
    <org_study_id>ICP-CL-00110</org_study_id>
    <nct_id>NCT04441450</nct_id>
  </id_info>
  <brief_title>ADME Study of [14C]ICP-022 in Healthy Males</brief_title>
  <official_title>Absorption, Metabolism, and Excretion of Oral 14C Radiolabeled ICP-022: An Open-Label, Phase I, Single-Dose Study in Healthy Males</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing InnoCare Pharma Tech Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing InnoCare Pharma Tech 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 investigate the absorption, the metabolic pathways and the&#xD;
      excretion of ICP-022 in healthy male adult participants after administration of a single oral&#xD;
      dose of 150 mg of 14C ICP-022.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Actual">August 6, 2019</completion_date>
  <primary_completion_date type="Actual">August 6, 2019</primary_completion_date>
  <phase>N/A</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>Distribution ratio of total radioactivity in whole blood and plasma of [14C]ICP-022</measure>
    <time_frame>Up to14 days</time_frame>
    <description>To investigate the pharmacokinetics of total radioactivity in plasma after oral [14C] ICP-022 in healthy volunteers, and the distribution ratio of total radioactivity in whole blood and plasma.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantitative analysis of total radioactivity in excreta after oral [14C] ICP-022 in healthy volunteers</measure>
    <time_frame>Up to14 days</time_frame>
    <description>Quantitative analysis of total radioactivity in excreta after oral [14C] ICP-022 in healthy volunteers, obtaining body material balance data and main excretion pathways</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quantitative analysis of the concentration of ICP-022 in plasma</measure>
    <time_frame>Up to14 days</time_frame>
    <description>Quantitative analysis of the concentration of ICP-022 in plasma to obtain the pharmacokinetic parameters of ICP-022</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The biotransformation pathways of [14C]ICP-022</measure>
    <time_frame>Up to14 days</time_frame>
    <description>Urine and fecal collection for metabolite profiling. Identify the main metabolites in humans after oral [14]ICP-022 in healthy volunteers to determine the main biotransformation pathways.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>[14C]ICP-022</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will take a single of 150mg 100μCi of [14C]ICP-022.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[14C]ICP-022</intervention_name>
    <description>150mg suspension containing 100μCi of [14C]ICP-022</description>
    <arm_group_label>[14C]ICP-022</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        key Inclusion criteria:&#xD;
&#xD;
          1. Weight: Body mass index (BMI) is 19~26 kg/m2&#xD;
&#xD;
          2. signing of informed consent&#xD;
&#xD;
          3. Volunteers are able to communicate well with the investigators and be able to complete&#xD;
             the trial according to the process&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. physical examination, vital signs, routine laboratory tests (blood routine, blood&#xD;
             biochemistry, blood coagulation routine, urine routine, stool routine + occult blood,&#xD;
             serum amylase, thyroid function, etc.), 12-lead ECG, Chest X-ray (Anteroposterior),&#xD;
             abdominal B-ultrasound (hepatobiliary, pancreas, spleen and kidney) and other&#xD;
             abnormalities and clinical significance.&#xD;
&#xD;
          2. ophthalmologic examination shows abnormality and clinical significance&#xD;
&#xD;
          3. Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive&#xD;
             test for HIV, positive test for Syphilis antibody.&#xD;
&#xD;
          4. Within 1 month before the screening, having not limited to known as hepatic enzyme&#xD;
             inducers, inhibitors or substrates; (eg, inducer - barbiturate, carbamazepine,&#xD;
             phenytoin, rifampicin, dexamethasone, rifabutin, rifapentine; inhibitors - SSRI&#xD;
             antidepressants, cimetidine, diltiazem, macrolides, verapamil, imidazole antifungals)&#xD;
             ;&#xD;
&#xD;
          5. Within 1 month before the screening, receiving the anticoagulant therapy such as&#xD;
             warfarin or thrombin inhibitor and/or aspirin antiplatelet therapy&#xD;
&#xD;
        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.&#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>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Soochow University</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</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>


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/NCT04441450
org study id: ICP-CL-00110
nct id: NCT04441450
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the absorption, the metabolic pathways and the
      excretion of ICP-022 in healthy male adult participants after administration of a single oral
      dose of 150 mg of 14C ICP-022.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Distribution ratio of total radioactivity in whole blood and plasma of [14C]ICP-022
time frame: Up to14 days
description: To investigate the pharmacokinetics of total radioactivity in plasma after oral [14C] ICP-022 in healthy volunteers, and the distribution ratio of total radioactivity in whole blood and plasma.
measure: Quantitative analysis of total radioactivity in excreta after oral [14C] ICP-022 in healthy volunteers
time frame: Up to14 days
description: Quantitative analysis of total radioactivity in excreta after oral [14C] ICP-022 in healthy volunteers, obtaining body material balance data and main excretion pathways
measure: Quantitative analysis of the concentration of ICP-022 in plasma
time frame: Up to14 days
description: Quantitative analysis of the concentration of ICP-022 in plasma to obtain the pharmacokinetic parameters of ICP-022
measure: The biotransformation pathways of [14C]ICP-022
time frame: Up to14 days
description: Urine and fecal collection for metabolite profiling. Identify the main metabolites in humans after oral [14]ICP-022 in healthy volunteers to determine the main biotransformation pathways.
arm group label: [14C]ICP-022
arm group type: Experimental
description: Subjects will take a single of 150mg 100μCi of [14C]ICP-022.
intervention type: Drug
intervention name: [14C]ICP-022
description: 150mg suspension containing 100μCi of [14C]ICP-022
arm group label: [14C]ICP-022
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor
sharing ipd: No