<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/NCT02985632</url>
  </required_header>
  <id_info>
    <org_study_id>CV006-030</org_study_id>
    <nct_id>NCT02985632</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Pharmacokinetics of BMS-986141 in Participants With Hepatic Impairment Compared to Healthy Participants</brief_title>
  <official_title>Single-dose Pharmacokinetics of BMS-986141 in Participants With Hepatic Impairment Compared to Healthy Participants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      An oral dose of BMS-986141 administered in Hepatic Impairment and Healthy Participants to&#xD;
      evaluate pharmacokinetics in this patient population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Business objectives have changed.&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 11, 2017</start_date>
  <completion_date type="Anticipated">July 7, 2017</completion_date>
  <primary_completion_date type="Anticipated">May 18, 2017</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum observed plasma concentration (Cmax) of BMS-986141</measure>
    <time_frame>Days 1-7 (healthy) Days 1-10 (heaptic Impairment)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986141</measure>
    <time_frame>Days 1-7 (healthy) Days 1-10 (heaptic Impairment)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986141</measure>
    <time_frame>Days 1-7 (healthy) Days 1-10 (heaptic Impairment)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve from time zero to 144 hours postdose (AUC(0-144h)) of BMS-986141</measure>
    <time_frame>Days 1-7 (healthy) Days 1-10 (heaptic Impairment)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), leading to discontinuation.</measure>
    <time_frame>Days 1-7 (healthy) Days 1-10 (heaptic Impairment)</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Hepatic Impairment</condition>
  <arm_group>
    <arm_group_label>Mild Hepatic Impairment Subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects given an oral dose of BMS-986141.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate Hepatic Impairment Subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects given an oral dose of BMS-986141.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects given an oral dose of BMS-986141.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-986141</intervention_name>
    <arm_group_label>Healthy Subjects</arm_group_label>
    <arm_group_label>Mild Hepatic Impairment Subjects</arm_group_label>
    <arm_group_label>Moderate Hepatic Impairment Subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women not of childbearing potential (WNOCBP), and males, ages 18 to 70 years,&#xD;
             inclusive.&#xD;
&#xD;
          -  BMI of 20.0 to 38.0 kg/m2 inclusive&#xD;
&#xD;
          -  Participants who a history of normal renal function&#xD;
&#xD;
          -  Subjects with hepatic impairment must be on a stable dose of medication and/or&#xD;
             treatment regimen&#xD;
&#xD;
          -  Healthy subjects to the extent possible matched to four subjects with hepatic&#xD;
             impairment with regard to body weight, age and gender, as determined by no clinically&#xD;
             significant deviation from normal in medical history, physical examination, ECGs, and&#xD;
             clinical laboratory determinations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any nonhepatic significant acute or chronic medical illness that could affect&#xD;
             participant safety or data interpretation as determined by the investigator.&#xD;
&#xD;
          -  History of recurrent dizziness or fall risk within 4 weeks of study drug&#xD;
             administration&#xD;
&#xD;
          -  History of primarily cholestatic liver diseases, autoimmune liver disease, metastatic&#xD;
             liver disease or active alcoholic hepatitis&#xD;
&#xD;
          -  History of known bleeding diathesis or coagulation disorder (eg, thrombotic&#xD;
             thrombocytopenic purpura)&#xD;
&#xD;
          -  Other protocol defined exclusion criteria could apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Pharmacology of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Center</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Liver Institute</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.bms.com/studyconnect/pages/home.aspx</url>
    <description>BMS Clinical Trial Education Resource</description>
  </link>
  <link>
    <url>http://www.fda.gov/Safety/Recalls/</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>February 2, 2017</last_update_submitted>
  <last_update_submitted_qc>February 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 6, 2017</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>Liver Diseases</mesh_term>
  </condition_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/NCT02985632
org study id: CV006-030
nct id: NCT02985632
lead sponsor: 
has dmc: No
An oral dose of BMS-986141 administered in Hepatic Impairment and Healthy Participants to
      evaluate pharmacokinetics in this patient population.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum observed plasma concentration (Cmax) of BMS-986141
time frame: Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986141
time frame: Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986141
time frame: Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
measure: Area under the plasma concentration-time curve from time zero to 144 hours postdose (AUC(0-144h)) of BMS-986141
time frame: Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
measure: Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), leading to discontinuation.
time frame: Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
arm group label: Mild Hepatic Impairment Subjects
arm group type: Experimental
description: Subjects given an oral dose of BMS-986141.
arm group label: Moderate Hepatic Impairment Subjects
arm group type: Experimental
description: Subjects given an oral dose of BMS-986141.
arm group label: Healthy Subjects
arm group type: Experimental
description: Subjects given an oral dose of BMS-986141.
intervention type: Drug
intervention name: BMS-986141
arm group label: Healthy Subjects
arm group label: Mild Hepatic Impairment Subjects
arm group label: Moderate Hepatic Impairment Subjects
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
facility: 
facility: 
facility: 
country: United States
url: http://www.bms.com/studyconnect/pages/home.aspx
description: BMS Clinical Trial Education Resource
url: http://www.fda.gov/Safety/Recalls/
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Liver Diseases