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/NCT05974046</url>
    </required_header>
    <id_info>
      <org_study_id>INDV-2000-105</org_study_id>
      <nct_id>NCT05974046</nct_id>
    </id_info>
    <brief_title>Single Dose Study of [14C]-IDV184001AN ([14C]-IDV184001) in Healthy Adult Male Participants</brief_title>
    <official_title>A Phase I, Open Label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Dose of Oral [14C]-IDV184001AN in Healthy Adult Male Participants</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Indivior Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Indivior 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>
        The purpose of this open label study is to characterise the absorption, metabolism,&#xD;
        excretion, and mass balance of [14C]-IDV184001AN ([14C]-IDV184001) in healthy adult male&#xD;
        participants.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study is designed as an open label, single-dose study in healthy adult participants for&#xD;
        the following reasons:&#xD;
  &#xD;
          -  Oral administration of IDV184001AN has demonstrated linear PK and thus [14C]IDV184001AN&#xD;
             will be given as a single dose.&#xD;
  &#xD;
          -  A comparator is not necessary for the evaluation of the objectives.&#xD;
  &#xD;
          -  Blinding of the study treatment is not required as there is no comparator.&#xD;
  &#xD;
          -  Conducting the study in healthy participants mitigates the potential confounding effects&#xD;
             of the disease state and concomitant medications.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 10, 2023</start_date>
    <completion_date type="Actual">July 21, 2023</completion_date>
    <primary_completion_date type="Actual">July 21, 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>Investigation of the route(s) of elimination and the overall mass balance of IDV184001, following a single oral dose of [14C] IDV184001AN in healthy adult male participants</measure>
      <time_frame>Pre-dose to 168 hours post-dose, collection time can be extended</time_frame>
      <description>Percent of total radioactivity in urine and feces relative to the administered radioactive dose.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Investigation of the route(s) of elimination and the overall mass balance of IDV184001, following a single oral dose of [14C] IDV184001AN in healthy adult male participants</measure>
      <time_frame>Pre-dose to 168 hours post-dose, collection time can be extended</time_frame>
      <description>The percent of the radioactive dose excreted in the urine and feces</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quantitation of total radioactivity in plasma and whole blood following a single oral dose of [14C] IDV184001AN in healthy adult male participants</measure>
      <time_frame>Pre-dose to 168 hours post-dose, collection time can be extended</time_frame>
      <description>AUC[last] (area under the concentration-time curve from time 0 to the time of the last quantifiable concentration calculated using the linear trapezoidal rule) as data permits.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quantitation of total radioactivity in plasma and whole blood following a single oral dose of [14C] IDV184001AN in healthy adult male participants</measure>
      <time_frame>Pre-dose to 168 hours post-dose, collection time can be extended</time_frame>
      <description>AUC[0-∞] (area under the concentration-time curve from time 0 extrapolated to infinite time) as data permits.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quantitation of total radioactivity in plasma and whole blood following a single oral dose of [14C] IDV184001AN in healthy adult male participants</measure>
      <time_frame>Pre-dose to 168 hours post-dose, collection time can be extended</time_frame>
      <description>AUC[extrap(%)] (percent of the area under the concentration-time curve due to extrapolation) as data permits.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quantitation of total radioactivity in plasma and whole blood following a single oral dose of [14C] IDV184001AN in healthy adult male participants</measure>
      <time_frame>Pre-dose to 168 hours post-dose, collection time can be extended</time_frame>
      <description>Cmax (maximum observed concentration) as data permits.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quantitation of total radioactivity in plasma and whole blood following a single oral dose of [14C] IDV184001AN in healthy adult male participants</measure>
      <time_frame>Pre-dose to 168 hours post-dose, collection time can be extended</time_frame>
      <description>Tmax (time of Cmax) as data permits.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quantitation of total radioactivity in plasma and whole blood following a single oral dose of [14C] IDV184001AN in healthy adult male participants</measure>
      <time_frame>Pre-dose to 168 hours post-dose, collection time can be extended</time_frame>
      <description>λz (terminal phase rate constant) as data permits.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quantitation of total radioactivity in plasma and whole blood following a single oral dose of [14C] IDV184001AN in healthy adult male participants</measure>
      <time_frame>Pre-dose to 168 hours post-dose, collection time can be extended</time_frame>
      <description>T1/2 (apparent terminal half-life) as data permits.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quantitation of total radioactivity in urine and feces following a single oral dose of [14C] IDV184001AN in healthy adult male participants</measure>
      <time_frame>Pre-dose to 168 hours post-dose, collection time can be extended</time_frame>
      <description>Ae[t1-t2] (amount of total radioactivity excreted/recovered within a given collection interval)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quantitation of total radioactivity in urine and feces following a single oral dose of [14C] IDV184001AN in healthy adult male participants</measure>
      <time_frame>Pre-dose to 168 hours post-dose, collection time can be extended</time_frame>
      <description>CumAe (cumulative amount of total radioactivity excreted/recovered)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quantitation of total radioactivity in urine and feces following a single oral dose of [14C] IDV184001AN in healthy adult male participants</measure>
      <time_frame>Pre-dose to 168 hours post-dose, collection time can be extended</time_frame>
      <description>%Dose (percent of administered dose excreted/recovered within a given collection interval)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quantitation of total radioactivity in urine and feces following a single oral dose of [14C] IDV184001AN in healthy adult male participants</measure>
      <time_frame>Pre-dose to 168 hours post-dose, collection time can be extended</time_frame>
      <description>Cum%Dose (cumulative percent of dose excreted/recovered)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quantitation of total radioactivity in urine following a single oral dose of [14C] IDV184001AN in healthy adult male participants</measure>
      <time_frame>Pre-dose to 168 hours post-dose, collection time can be extended</time_frame>
      <description>CLr (renal clearance)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetic profile of unlabelled IDV184001 and M12 in plasma following a single oral dose of [14C] IDV184001AN in healthy adult male participants</measure>
      <time_frame>Pre-dose to 168 hours post-dose</time_frame>
      <description>AUC[last], as data permits</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetic profile of unlabelled IDV184001 and M12 in plasma following a single oral dose of [14C] IDV184001AN in healthy adult male participants</measure>
      <time_frame>Pre-dose to 168 hours post-dose</time_frame>
      <description>AUC[0-∞], as data permits</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetic profile of unlabelled IDV184001 and M12 in plasma following a single oral dose of [14C] IDV184001AN in healthy adult male participants</measure>
      <time_frame>Pre-dose to 168 hours post-dose</time_frame>
      <description>AUC[extrap(%)], as data permits</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetic profile of unlabelled IDV184001 and M12 in plasma following a single oral dose of [14C] IDV184001AN in healthy adult male participants</measure>
      <time_frame>Pre-dose to 168 hours post-dose</time_frame>
      <description>Cmax, as data permits</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetic profile of unlabelled IDV184001 and M12 in plasma following a single oral dose of [14C] IDV184001AN in healthy adult male participants</measure>
      <time_frame>Pre-dose to 168 hours post-dose</time_frame>
      <description>Tmax, as data permits</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetic profile of unlabelled IDV184001 and M12 in plasma following a single oral dose of [14C] IDV184001AN in healthy adult male participants</measure>
      <time_frame>Pre-dose to 168 hours post-dose</time_frame>
      <description>λz, as data permits</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetic profile of unlabelled IDV184001 and M12 in plasma following a single oral dose of [14C] IDV184001AN in healthy adult male participants</measure>
      <time_frame>Pre-dose to 168 hours post-dose</time_frame>
      <description>T1/2, as data permits</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetic profile of unlabelled IDV184001 and M12 in plasma following a single oral dose of [14C] IDV184001AN in healthy adult male participants</measure>
      <time_frame>Pre-dose to 168 hours post-dose</time_frame>
      <description>Ratio of unlabelled IDV184001 and M12 in plasma to plasma total radioactivity for AUC[last], where appropriate</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetic profile of unlabelled IDV184001 and M12 in plasma following a single oral dose of [14C] IDV184001AN in healthy adult male participants</measure>
      <time_frame>Pre-dose to 168 hours post-dose</time_frame>
      <description>Ratio of unlabelled IDV184001 and M12 in plasma to plasma total radioactivity for Cmax, where appropriate</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Characterization of metabolite identification, profiling and quantitation for IDV184001 in plasma, urine, and feces following a single oral dose of [14C] IDV184001AN in healthy adult male participants</measure>
      <time_frame>Pre-dose to 168 hours post-dose, collection time can be extended</time_frame>
      <description>Determination of % of AUC of each identified metabolites in plasma</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Characterization of metabolite identification, profiling and quantitation for IDV184001 in plasma, urine, and feces following a single oral dose of [14C] IDV184001AN in healthy adult male participants</measure>
      <time_frame>Pre-dose to 168 hours post-dose, collection time can be extended</time_frame>
      <description>Determination of % of dose of each identified metabolites in urine</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Characterization of metabolite identification, profiling and quantitation for IDV184001 in plasma, urine, and feces following a single oral dose of [14C] IDV184001AN in healthy adult male participants</measure>
      <time_frame>Pre-dose to 168 hours post-dose, collection time can be extended</time_frame>
      <description>Determination of % of dose of each identified metabolites in feces</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Determination of the ratio of total radioactivity concentration equivalents in whole blood versus plasma following a single oral dose of [14C] IDV184001AN in healthy adult male participants</measure>
      <time_frame>Pre-dose to 168 hours post-dose, collection time can be extended</time_frame>
      <description>The ratio of total radioactivity concentration equivalents in whole blood relative to plasma at each time-matched determination of total radioactivity in whole blood and plasma</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Assessment of the safety and tolerability (incidence, seriousness, severity, and relatedness of treatment-emergent adverse events) of a single oral dose of [14C] IDV184001AN as determined by adverse event reporting</measure>
      <time_frame>From informed consent signature up to 7 weeks (screening to end of study)</time_frame>
      <description>Incidence, seriousness, severity, and relatedness of treatment-emergent adverse events</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">7</enrollment>
    <condition>Opioid Use Disorder</condition>
    <arm_group>
      <arm_group_label>Treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>[14C]IDV184001AN</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>[14C]IDV184001AN</intervention_name>
      <description>[14C]-IDV184001AN 200 mg/~100 µCi/ 15 g oral suspension</description>
      <arm_group_label>Treatment</arm_group_label>
      <other_name>[14C]-IDV184001</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants are eligible to be included in the study only if all of the following&#xD;
               criteria apply:&#xD;
  &#xD;
                 1. Participant must be 19 to 55 years of age inclusive, at the time of signing the&#xD;
                    informed consent.&#xD;
  &#xD;
                 2. Participant must have body weight of a minimum of 50.0 kg at the Screening Visit&#xD;
                    and body mass index within the range 18.0 to 32.0 kg/m2 (inclusive).&#xD;
  &#xD;
                 3. Participant must be male and who is healthy as determined by medical evaluation.&#xD;
  &#xD;
                 4. Participant agrees to follow contraception guidelines from the time of dosing of&#xD;
                    study drug until at least 90 days after dosing of study drug. This includes use&#xD;
                    of highly effective contraception if sexually active with a non-pregnant partner&#xD;
                    of child-bearing potential, and agreement not to donate sperm from dosing until&#xD;
                    at least 90 days post-dose. There are no restrictions for a vasectomised male&#xD;
                    provided his vasectomy has been performed 4 months or more prior to dosing.&#xD;
  &#xD;
                 5. Participant must be continuous non smoker who has not used nicotine and tobacco&#xD;
                    containing products for at least 3 months prior to dosing based on participant&#xD;
                    self-reporting.&#xD;
  &#xD;
                 6. Participant must be capable of giving signed informed consent, which includes&#xD;
                    compliance with the requirements and restrictions listed in the ICF and&#xD;
                    compliance with contraception guidelines.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants are excluded from the study if any of the following criteria apply:&#xD;
  &#xD;
                 1. Have an ongoing medical history of clinically significant neurological,&#xD;
                    cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease,&#xD;
                    psychiatric or other disorder as judged by an Investigator that could potentially&#xD;
                    affect the study outcomes or compromise participant safety.&#xD;
  &#xD;
                 2. Have clinically significant abnormal biochemistry, haematology or urinalysis&#xD;
                    results as judged by an Investigator.&#xD;
  &#xD;
                 3. Have a history of narcolepsy or sleep apnea.&#xD;
  &#xD;
                 4. Have disorders that may interfere with drug absorption, distribution, metabolism&#xD;
                    and excretion processes.&#xD;
  &#xD;
                 5. Current active hepatic or biliary disease.&#xD;
  &#xD;
                 6. Participants with cholecystectomy &lt;90 days prior to the Screening Visit.&#xD;
  &#xD;
                 7. Positive test results for HIV-1/HIV-2 antibodies, HBsAg or Hepatitis C antibodies&#xD;
                    at the Screening Visit.&#xD;
  &#xD;
                 8. Have a blood pressure reading outside of the following range: Systolic &lt;86 or&#xD;
                    &gt;149 mmHg; Diastolic &lt;50 or &gt;94 mmHg at the Screening Visit.&#xD;
  &#xD;
                 9. Serious cardiac illness or other medical condition including, but not limited to:&#xD;
  &#xD;
                      -  Uncontrolled arrhythmias&#xD;
  &#xD;
                      -  History of congestive heart failure&#xD;
  &#xD;
                      -  QTcF &gt;450 msec or history of prolonged QT syndrome&#xD;
  &#xD;
                      -  Myocardial infarction&#xD;
  &#xD;
                      -  Uncontrolled symptomatic angina&#xD;
  &#xD;
                10. History of suicidal ideation within 30 days prior to providing written informed&#xD;
                    consent as evidenced by answering &quot;yes' to questions 4 or 5 on the suicidal&#xD;
                    ideation portion of the C-SSRS completed at the Screening Visit or history of a&#xD;
                    suicide attempt (per the C-SSRS) in the 6 months prior to informed consent.&#xD;
  &#xD;
                11. Healthy participants who are taking, or have taken, any prescribed or over the&#xD;
                    counter drugs (other than 2 grams of acetaminophen per 24-hour period as of Day 1&#xD;
                    or thyroid hormone replacement therapy) or herbal remedies in the 14 days or 5&#xD;
                    half-lives (whichever is longer) prior to dosing of study drug.&#xD;
  &#xD;
                12. Treatment with any known drugs that are moderate or strong inhibitors/inducers of&#xD;
                    CYP3A4 or CYP2C19, including St. John's Wort, within 30 days prior to dosing of&#xD;
                    study drug.&#xD;
  &#xD;
                13. Any consumption of food or drink containing poppy seeds, grapefruit or Seville&#xD;
                    oranges within 14 days prior to dosing of study drug.&#xD;
  &#xD;
                14. Regular alcohol consumption &gt;21 units per week (1 unit = ½ pint beer, 25 mL of&#xD;
                    40% spirit or a 125 mL glass of wine).&#xD;
  &#xD;
                15. Positive test result for alcohol and/or drugs of abuse at the Screening Visit or&#xD;
                    at check-in.&#xD;
  &#xD;
                16. Concurrent treatment or treatment with an investigational drug or device within&#xD;
                    30 days or 5 half-lives (whichever is longer) prior to dosing of study drug.&#xD;
  &#xD;
                17. Blood donation of approximately 500 mL or more within 56 days or plasma donation&#xD;
                    within 7 days prior to the Screening Visit.&#xD;
  &#xD;
                18. Known hypersensitivity to INDV-2000.&#xD;
  &#xD;
                19. Has less than 1 bowel movement every 2 days.&#xD;
  &#xD;
                20. Recent history of abnormal bowel movements, such as diarrhea, loose stools or&#xD;
                    constipation, within 2 weeks prior to dosing of study drug.&#xD;
  &#xD;
                21. Has received radiolabelled substances or has been exposed to radiation sources&#xD;
                    over the past 12 months or is likely to receive radiation exposure or&#xD;
                    radioisotopes within the next 12 months such that participation in this study&#xD;
                    would increase their total exposure beyond the recommended levels considered safe&#xD;
                    (ie, weighted annual limit recommended by the FDA 21CFR361 of 3000 mrem; FDA&#xD;
                    2023).&#xD;
  &#xD;
                22. Site staff and/or participants who have a financial interest in, or an immediate&#xD;
                    family member of either the site staff and/or Indivior employees, directly&#xD;
                    involved in the study.&#xD;
  &#xD;
                23. Major surgical procedure (as defined by the Investigator) within 90 days prior to&#xD;
                    dosing of study drug or still recovering from prior surgery.&#xD;
  &#xD;
                24. Concurrent enrolment in another clinical study, unless it is an observational&#xD;
                    study.&#xD;
  &#xD;
                25. Participants who are unable, in the opinion of the Investigator, to comply fully&#xD;
                    with the study requirements.&#xD;
  &#xD;
                26. Any condition that, in the opinion of the Investigator or Indivior, would&#xD;
                    interfere with evaluation of the study drug or interpretation of participant&#xD;
                    safety or study results.&#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>
    <overall_official>
      <last_name>Global Director Clinical Development</last_name>
      <role>Study Director</role>
      <affiliation>Indivior Inc.</affiliation>
    </overall_official>
    <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>August 2023</verification_date>
    <study_first_submitted>June 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>healthy volunteers</keyword>
    <keyword>ADME</keyword>
    <keyword>OUD</keyword>
    <keyword>radiolabel</keyword>
    <keyword>metabolism</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Opioid-Related Disorders</mesh_term>
    </condition_browse>
    <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/NCT05974046
  org study id: INDV-2000-105
  nct id: NCT05974046
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this open label study is to characterise the absorption, metabolism,
        excretion, and mass balance of [14C]-IDV184001AN ([14C]-IDV184001) in healthy adult male
        participants.
  The study is designed as an open label, single-dose study in healthy adult participants for
        the following reasons:
  
          -  Oral administration of IDV184001AN has demonstrated linear PK and thus [14C]IDV184001AN
             will be given as a single dose.
  
          -  A comparator is not necessary for the evaluation of the objectives.
  
          -  Blinding of the study treatment is not required as there is no comparator.
  
          -  Conducting the study in healthy participants mitigates the potential confounding effects
             of the disease state and concomitant medications.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Investigation of the route(s) of elimination and the overall mass balance of IDV184001, following a single oral dose of [14C] IDV184001AN in healthy adult male participants
  time frame: Pre-dose to 168 hours post-dose, collection time can be extended
  description: Percent of total radioactivity in urine and feces relative to the administered radioactive dose.
  measure: Investigation of the route(s) of elimination and the overall mass balance of IDV184001, following a single oral dose of [14C] IDV184001AN in healthy adult male participants
  time frame: Pre-dose to 168 hours post-dose, collection time can be extended
  description: The percent of the radioactive dose excreted in the urine and feces
  measure: Quantitation of total radioactivity in plasma and whole blood following a single oral dose of [14C] IDV184001AN in healthy adult male participants
  time frame: Pre-dose to 168 hours post-dose, collection time can be extended
  description: AUC[last] (area under the concentration-time curve from time 0 to the time of the last quantifiable concentration calculated using the linear trapezoidal rule) as data permits.
  measure: Quantitation of total radioactivity in plasma and whole blood following a single oral dose of [14C] IDV184001AN in healthy adult male participants
  time frame: Pre-dose to 168 hours post-dose, collection time can be extended
  description: AUC[0-∞] (area under the concentration-time curve from time 0 extrapolated to infinite time) as data permits.
  measure: Quantitation of total radioactivity in plasma and whole blood following a single oral dose of [14C] IDV184001AN in healthy adult male participants
  time frame: Pre-dose to 168 hours post-dose, collection time can be extended
  description: AUC[extrap(%)] (percent of the area under the concentration-time curve due to extrapolation) as data permits.
  measure: Quantitation of total radioactivity in plasma and whole blood following a single oral dose of [14C] IDV184001AN in healthy adult male participants
  time frame: Pre-dose to 168 hours post-dose, collection time can be extended
  description: Cmax (maximum observed concentration) as data permits.
  measure: Quantitation of total radioactivity in plasma and whole blood following a single oral dose of [14C] IDV184001AN in healthy adult male participants
  time frame: Pre-dose to 168 hours post-dose, collection time can be extended
  description: Tmax (time of Cmax) as data permits.
  measure: Quantitation of total radioactivity in plasma and whole blood following a single oral dose of [14C] IDV184001AN in healthy adult male participants
  time frame: Pre-dose to 168 hours post-dose, collection time can be extended
  description: λz (terminal phase rate constant) as data permits.
  measure: Quantitation of total radioactivity in plasma and whole blood following a single oral dose of [14C] IDV184001AN in healthy adult male participants
  time frame: Pre-dose to 168 hours post-dose, collection time can be extended
  description: T1/2 (apparent terminal half-life) as data permits.
  measure: Quantitation of total radioactivity in urine and feces following a single oral dose of [14C] IDV184001AN in healthy adult male participants
  time frame: Pre-dose to 168 hours post-dose, collection time can be extended
  description: Ae[t1-t2] (amount of total radioactivity excreted/recovered within a given collection interval)
  measure: Quantitation of total radioactivity in urine and feces following a single oral dose of [14C] IDV184001AN in healthy adult male participants
  time frame: Pre-dose to 168 hours post-dose, collection time can be extended
  description: CumAe (cumulative amount of total radioactivity excreted/recovered)
  measure: Quantitation of total radioactivity in urine and feces following a single oral dose of [14C] IDV184001AN in healthy adult male participants
  time frame: Pre-dose to 168 hours post-dose, collection time can be extended
  description: %Dose (percent of administered dose excreted/recovered within a given collection interval)
  measure: Quantitation of total radioactivity in urine and feces following a single oral dose of [14C] IDV184001AN in healthy adult male participants
  time frame: Pre-dose to 168 hours post-dose, collection time can be extended
  description: Cum%Dose (cumulative percent of dose excreted/recovered)
  measure: Quantitation of total radioactivity in urine following a single oral dose of [14C] IDV184001AN in healthy adult male participants
  time frame: Pre-dose to 168 hours post-dose, collection time can be extended
  description: CLr (renal clearance)
  measure: Pharmacokinetic profile of unlabelled IDV184001 and M12 in plasma following a single oral dose of [14C] IDV184001AN in healthy adult male participants
  time frame: Pre-dose to 168 hours post-dose
  description: AUC[last], as data permits
  measure: Pharmacokinetic profile of unlabelled IDV184001 and M12 in plasma following a single oral dose of [14C] IDV184001AN in healthy adult male participants
  time frame: Pre-dose to 168 hours post-dose
  description: AUC[0-∞], as data permits
  measure: Pharmacokinetic profile of unlabelled IDV184001 and M12 in plasma following a single oral dose of [14C] IDV184001AN in healthy adult male participants
  time frame: Pre-dose to 168 hours post-dose
  description: AUC[extrap(%)], as data permits
  measure: Pharmacokinetic profile of unlabelled IDV184001 and M12 in plasma following a single oral dose of [14C] IDV184001AN in healthy adult male participants
  time frame: Pre-dose to 168 hours post-dose
  description: Cmax, as data permits
  measure: Pharmacokinetic profile of unlabelled IDV184001 and M12 in plasma following a single oral dose of [14C] IDV184001AN in healthy adult male participants
  time frame: Pre-dose to 168 hours post-dose
  description: Tmax, as data permits
  measure: Pharmacokinetic profile of unlabelled IDV184001 and M12 in plasma following a single oral dose of [14C] IDV184001AN in healthy adult male participants
  time frame: Pre-dose to 168 hours post-dose
  description: λz, as data permits
  measure: Pharmacokinetic profile of unlabelled IDV184001 and M12 in plasma following a single oral dose of [14C] IDV184001AN in healthy adult male participants
  time frame: Pre-dose to 168 hours post-dose
  description: T1/2, as data permits
  measure: Pharmacokinetic profile of unlabelled IDV184001 and M12 in plasma following a single oral dose of [14C] IDV184001AN in healthy adult male participants
  time frame: Pre-dose to 168 hours post-dose
  description: Ratio of unlabelled IDV184001 and M12 in plasma to plasma total radioactivity for AUC[last], where appropriate
  measure: Pharmacokinetic profile of unlabelled IDV184001 and M12 in plasma following a single oral dose of [14C] IDV184001AN in healthy adult male participants
  time frame: Pre-dose to 168 hours post-dose
  description: Ratio of unlabelled IDV184001 and M12 in plasma to plasma total radioactivity for Cmax, where appropriate
  measure: Characterization of metabolite identification, profiling and quantitation for IDV184001 in plasma, urine, and feces following a single oral dose of [14C] IDV184001AN in healthy adult male participants
  time frame: Pre-dose to 168 hours post-dose, collection time can be extended
  description: Determination of % of AUC of each identified metabolites in plasma
  measure: Characterization of metabolite identification, profiling and quantitation for IDV184001 in plasma, urine, and feces following a single oral dose of [14C] IDV184001AN in healthy adult male participants
  time frame: Pre-dose to 168 hours post-dose, collection time can be extended
  description: Determination of % of dose of each identified metabolites in urine
  measure: Characterization of metabolite identification, profiling and quantitation for IDV184001 in plasma, urine, and feces following a single oral dose of [14C] IDV184001AN in healthy adult male participants
  time frame: Pre-dose to 168 hours post-dose, collection time can be extended
  description: Determination of % of dose of each identified metabolites in feces
  measure: Determination of the ratio of total radioactivity concentration equivalents in whole blood versus plasma following a single oral dose of [14C] IDV184001AN in healthy adult male participants
  time frame: Pre-dose to 168 hours post-dose, collection time can be extended
  description: The ratio of total radioactivity concentration equivalents in whole blood relative to plasma at each time-matched determination of total radioactivity in whole blood and plasma
  measure: Assessment of the safety and tolerability (incidence, seriousness, severity, and relatedness of treatment-emergent adverse events) of a single oral dose of [14C] IDV184001AN as determined by adverse event reporting
  time frame: From informed consent signature up to 7 weeks (screening to end of study)
  description: Incidence, seriousness, severity, and relatedness of treatment-emergent adverse events
  arm group label: Treatment
  arm group type: Experimental
  description: [14C]IDV184001AN
  intervention type: Drug
  intervention name: [14C]IDV184001AN
  description: [14C]-IDV184001AN 200 mg/~100 µCi/ 15 g oral suspension
  arm group label: Treatment
  other name: [14C]-IDV184001
  criteria: 
  gender: Male
  minimum age: 19 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Global Director Clinical Development
  role: Study Director
  affiliation: Indivior Inc.
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Opioid-Related Disorders
  sharing ipd: No