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/NCT05995366</url>
    </required_header>
    <id_info>
      <org_study_id>M24-223</org_study_id>
      <nct_id>NCT05995366</nct_id>
    </id_info>
    <brief_title>A Study to Assess the Mass Balance of [14C] ABBV-903 in Healthy Male Participants Following Single Oral Dose Administration</brief_title>
    <official_title>Mass Balance Study of [14C] ABBV-903 in Healthy Male Subjects Following Single Oral Dose Administration</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AbbVie</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AbbVie</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to evaluate the mass balance and safety of [14C] ABBV-903 in&#xD;
        healthy male volunteers following a single oral dose administration.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">August 18, 2023</start_date>
    <completion_date type="Anticipated">October 13, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 13, 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>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Maximum observed concentration (Cmax) of ABBV-903</measure>
      <time_frame>Up to Day 16</time_frame>
      <description>Cmax of ABBV-903 will be assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time to Cmax (peak time, Tmax) of ABBV-903</measure>
      <time_frame>Up to Day 16</time_frame>
      <description>Tmax of ABBV-903 will be assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Terminal Phase Elimination Half-life (t1/2) of ABBV-903</measure>
      <time_frame>Up to Day 16</time_frame>
      <description>Terminal phase elimination half-life (t1/2) will be assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to the Time of the Last Measurable Concentration (AUC0-t) of ABBV-903</measure>
      <time_frame>Up to Day 16</time_frame>
      <description>AUC0-t of ABBV-903 will be assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>AUC from Time 0 to Infinite Time (AUC0-t) of ABBV-903</measure>
      <time_frame>Up to Day 16</time_frame>
      <description>AUC0-inf of ABBV-903 will be assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Adverse Events (AEs)</measure>
      <time_frame>Baseline to Day 46</time_frame>
      <description>An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">7</enrollment>
    <condition>Healthy Volunteer</condition>
    <arm_group>
      <arm_group_label>ABBV-903</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive ABBV-903 on Day 1.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>ABBV-903</intervention_name>
      <description>Solution; Oral</description>
      <arm_group_label>ABBV-903</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Body Mass Index (BMI) is &gt;= 18.0 to &lt;= 32.0 kg/m2 after rounding to the tenths decimal&#xD;
               at Screening and upon initial confinement.&#xD;
  &#xD;
            -  A condition of general good health, based upon the results of a medical history,&#xD;
               physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram&#xD;
               (ECG).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History: of epilepsy, any clinically significant cardiac, respiratory (except mild&#xD;
               asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, Gilbert's&#xD;
               Syndrome, hematologic or psychiatric disease or disorder, or any uncontrolled medical&#xD;
               illness&#xD;
  &#xD;
            -  History of any clinically significant illness/infection/major febrile illness,&#xD;
               hospitalization, or any surgical procedure within 30 days prior to study drug&#xD;
               administration.&#xD;
  &#xD;
            -  Consider fathering a child or donating sperm during the study and for 94 days after&#xD;
               study drug administration.&#xD;
  &#xD;
            -  Has had significant exposure to radiation for professional or medical reasons (e.g.,&#xD;
               serial x-rays or computed tomography scans, barium meal, current employment in a job&#xD;
               requiring radiation exposure monitoring), except dental x-rays, within 12 months prior&#xD;
               to study drug administration.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>ABBVIE INC.</last_name>
      <role>Study Director</role>
      <affiliation>AbbVie</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Fortrea Clinical Research Unit Inc. /ID# 253962</name>
        <address>
          <city>Madison</city>
          <state>Wisconsin</state>
          <zip>53704</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.abbvieclinicaltrials.com/study/?id=M24-223</url>
      <description>Related Info</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Healthy Volunteer</keyword>
    <keyword>ABBV-903</keyword>
    <patient_data>
      <sharing_ipd>No</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/NCT05995366
  org study id: M24-223
  nct id: NCT05995366
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The purpose of this study is to evaluate the mass balance and safety of [14C] ABBV-903 in
        healthy male volunteers following a single oral dose administration.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Maximum observed concentration (Cmax) of ABBV-903
  time frame: Up to Day 16
  description: Cmax of ABBV-903 will be assessed.
  measure: Time to Cmax (peak time, Tmax) of ABBV-903
  time frame: Up to Day 16
  description: Tmax of ABBV-903 will be assessed.
  measure: Terminal Phase Elimination Half-life (t1/2) of ABBV-903
  time frame: Up to Day 16
  description: Terminal phase elimination half-life (t1/2) will be assessed.
  measure: Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to the Time of the Last Measurable Concentration (AUC0-t) of ABBV-903
  time frame: Up to Day 16
  description: AUC0-t of ABBV-903 will be assessed.
  measure: AUC from Time 0 to Infinite Time (AUC0-t) of ABBV-903
  time frame: Up to Day 16
  description: AUC0-inf of ABBV-903 will be assessed.
  measure: Number of Participants with Adverse Events (AEs)
  time frame: Baseline to Day 46
  description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
  arm group label: ABBV-903
  arm group type: Experimental
  description: Participants will receive ABBV-903 on Day 1.
  intervention type: Drug
  intervention name: ABBV-903
  description: Solution; Oral
  arm group label: ABBV-903
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: ABBVIE INC.
  role: Study Director
  affiliation: AbbVie
  facility: 
  country: United States
  url: https://www.abbvieclinicaltrials.com/study/?id=M24-223
  description: Related Info
  responsible party type: Sponsor
  sharing ipd: No