<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/NCT04415645</url>
  </required_header>
  <id_info>
    <org_study_id>VVZ149-HMB-P1-US101</org_study_id>
    <nct_id>NCT04415645</nct_id>
  </id_info>
  <brief_title>Absorption, Metabolism, Excretion, and Mass Balance Study of [14C]-VVZ-149 in Healthy Adult Male Subjects</brief_title>
  <official_title>Phase 1, Open-Label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Intravenous Dose of [14C]-VVZ-149 in Healthy Adult Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vivozon, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vivozon, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</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 IV infusion of [14C]-VVZ-149 in healthy adult male subjects. Whole blood,&#xD;
      plasma, urine, and fecal samples will be analyzed for at least 72 hours following the start&#xD;
      of infusion to measure total radioactivity and plasma drug concentrations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 24, 2020</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">March 6, 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mass balance</measure>
    <time_frame>Day 15</time_frame>
    <description>Sum of the percent of the total radioactivity recovered in urine and feces relative to the administered radioactivity dose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total radioactivity (TRA) concentration equivalents in plasma</measure>
    <time_frame>Day 15</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>TRA concentration equivalents in urine</measure>
    <time_frame>Day 15</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>TRA concentration equivalents in feces</measure>
    <time_frame>Day 15</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Drug concentrations in plasma</measure>
    <time_frame>Hour 48</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatment-emergent adverse events</measure>
    <time_frame>Day 15</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Healthy Adult Male</condition>
  <arm_group>
    <arm_group_label>VVZ-149 Injections</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[14C]-VVZ-149</intervention_name>
    <description>A single IV infusion of radio-labeled VVZ-149</description>
    <arm_group_label>VVZ-149 Injections</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Healthy, adult, male, 19-55 years of age, inclusive&#xD;
&#xD;
          -  Continuous non-smoker&#xD;
&#xD;
          -  BMI ≥ 18.0 and ≤ 32.0 kg/m2&#xD;
&#xD;
          -  Medically healthy with no clinically significant medical history or findings&#xD;
&#xD;
          -  Must agree to adhere to the contraception requirements&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  History or presence of clinically significant medical or psychiatric condition or&#xD;
             disease&#xD;
&#xD;
          -  History or presence of alcohol or drug abuse within the past 2 years&#xD;
&#xD;
          -  History, presence or evidence of cardiovascular, renal or hepatic impairment&#xD;
&#xD;
          -  Less or abnormal bowel movements&#xD;
&#xD;
          -  Unable to refrain from or anticipates the use of any prohibited drugs&#xD;
&#xD;
          -  Recent donation of blood/plasma or significant blood loss&#xD;
&#xD;
          -  Radiation exposure within 12 months&#xD;
&#xD;
          -  Participation in another clinical study within 30 days&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Celerion</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 29, 2020</last_update_submitted>
  <last_update_submitted_qc>May 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 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/NCT04415645
org study id: VVZ149-HMB-P1-US101
nct id: NCT04415645
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study
      following a single IV infusion of [14C]-VVZ-149 in healthy adult male subjects. Whole blood,
      plasma, urine, and fecal samples will be analyzed for at least 72 hours following the start
      of infusion to measure total radioactivity and plasma drug concentrations.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Mass balance
time frame: Day 15
description: Sum of the percent of the total radioactivity recovered in urine and feces relative to the administered radioactivity dose
measure: Total radioactivity (TRA) concentration equivalents in plasma
time frame: Day 15
measure: TRA concentration equivalents in urine
time frame: Day 15
measure: TRA concentration equivalents in feces
time frame: Day 15
measure: Drug concentrations in plasma
time frame: Hour 48
measure: Treatment-emergent adverse events
time frame: Day 15
arm group label: VVZ-149 Injections
arm group type: Experimental
intervention type: Drug
intervention name: [14C]-VVZ-149
description: A single IV infusion of radio-labeled VVZ-149
arm group label: VVZ-149 Injections
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor