<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/NCT02206711</url>
  </required_header>
  <id_info>
    <org_study_id>206291</org_study_id>
    <secondary_id>AI468-036</secondary_id>
    <nct_id>NCT02206711</nct_id>
  </id_info>
  <brief_title>Study of the Absorption, Metabolism, and Route of Elimination of a Novel Class of Anti-HIV 1 Drugs (BMS-955176) in Humans.</brief_title>
  <official_title>Pharmacokinetics and Metabolism of [14C] BMS-955176 in Healthy Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ViiV Healthcare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>ViiV Healthcare</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and&#xD;
      extent of elimination, safety and tolerability of a single oral dose of [14C] BMS-955176 in&#xD;
      healthy male subjects. There is no formal research hypothesis to be statistically tested for&#xD;
      this study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 8, 2014</start_date>
  <completion_date type="Actual">September 9, 2014</completion_date>
  <primary_completion_date type="Actual">September 9, 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To asses the PK (AUC, Cmax) of a single oral dose</measure>
    <time_frame>Day 1 through Day 13 (predose to 288 hours)</time_frame>
    <description>Serial blood samples for PK parameters determined from plasma concentration versus time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To estimate extent of elimination of a single oral dose (% TRA recovery)</measure>
    <time_frame>Day 1 through Day 13 (predose to 288 hours)</time_frame>
    <description>Sample of urinary/fecal/bile will be collected for determining total recovery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety Assessment</measure>
    <time_frame>Day 1 through Day 13</time_frame>
    <description>Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Single oral dose of [14C] BMS 955176</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single 180 mg oral dose of [14C] BMS-955176 containing approximately 80 microcurie of total radioactivity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nasoduodenal (ND) Tube Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single dose of [14C] BMS 955176 on Day 1 with ND placement 1 hour post dose to facilitate continuous bile collection though 8 hours post dose.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-955176</intervention_name>
    <description>Single dose of drug on Day 1</description>
    <arm_group_label>Nasoduodenal (ND) Tube Cohort</arm_group_label>
    <arm_group_label>Single oral dose of [14C] BMS 955176</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy Male subjects&#xD;
&#xD;
          -  Ages 18-50 years&#xD;
&#xD;
          -  Body weight of at least 110 lbs (50kg)&#xD;
&#xD;
          -  BMI of 18 to 32 kg/m^2&#xD;
&#xD;
          -  non-smoking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically significant diagnostic or therapeutic radiation exposure within the&#xD;
             previous 12 months (eg serial X-ray or CAT scans, barium meals).&#xD;
&#xD;
          -  gastrointestinal disease including gastrointestinal surgery&#xD;
&#xD;
          -  constipation or irregular bowel movements&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Viiv Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>ViiV Healthcare</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</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>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>April 13, 2018</last_update_submitted>
  <last_update_submitted_qc>April 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>BMS-955176</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02206711
org study id: 206291
secondary id: AI468-036
nct id: NCT02206711
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and
      extent of elimination, safety and tolerability of a single oral dose of [14C] BMS-955176 in
      healthy male subjects. There is no formal research hypothesis to be statistically tested for
      this study.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: To asses the PK (AUC, Cmax) of a single oral dose
time frame: Day 1 through Day 13 (predose to 288 hours)
description: Serial blood samples for PK parameters determined from plasma concentration versus time
measure: To estimate extent of elimination of a single oral dose (% TRA recovery)
time frame: Day 1 through Day 13 (predose to 288 hours)
description: Sample of urinary/fecal/bile will be collected for determining total recovery.
measure: Safety Assessment
time frame: Day 1 through Day 13
description: Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.
arm group label: Single oral dose of [14C] BMS 955176
arm group type: Experimental
description: A single 180 mg oral dose of [14C] BMS-955176 containing approximately 80 microcurie of total radioactivity.
arm group label: Nasoduodenal (ND) Tube Cohort
arm group type: Experimental
description: A single dose of [14C] BMS 955176 on Day 1 with ND placement 1 hour post dose to facilitate continuous bile collection though 8 hours post dose.
intervention type: Drug
intervention name: BMS-955176
description: Single dose of drug on Day 1
arm group label: Nasoduodenal (ND) Tube Cohort
arm group label: Single oral dose of [14C] BMS 955176
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Viiv Clinical Trials
role: Study Director
affiliation: ViiV Healthcare
facility: 
country: United States
responsible party type: Sponsor
mesh term: HIV Infections
mesh term: BMS-955176