<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/NCT02982707</url>
  </required_header>
  <id_info>
    <org_study_id>CV010-013</org_study_id>
    <nct_id>NCT02982707</nct_id>
  </id_info>
  <brief_title>Single-dose Pharmacokinetics of BMS-986177 in Participants With Hepatic Impairment Compared to Healthy Participants</brief_title>
  <official_title>Single-dose Pharmacokinetics of BMS-986177 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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A single oral dose of BMS-986177 administered to subjects of mild hepatic impairment,&#xD;
      moderate hepatic impairment and healthy matched subjects to evaluate pharmacokinetics,&#xD;
      safety, and tolerability in these subjects&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">September 28, 2018</completion_date>
  <primary_completion_date type="Actual">September 28, 2018</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-986177</measure>
    <time_frame>Up to 5 days</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-987177</measure>
    <time_frame>Up to 5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve from time zero to the time the last quantifiable concentration (AUC(0-T)) of BMS-986177</measure>
    <time_frame>Up to 5 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve from time zero to (AUC(0-72)) of BMS-986177</measure>
    <time_frame>Up to 5 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation</measure>
    <time_frame>Screening until 30 days after discontinuation of dosing or subject's participation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with clinical laboratory abnormalities</measure>
    <time_frame>Screening until 30 days after discontinuation of dosing or subject's participation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with clinically significant changes in electrical activity of the heart measured by electrocardiogram (ECG)</measure>
    <time_frame>Screening until 30 days after discontinuation of dosing or subject's participation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with vital sign abnormalities</measure>
    <time_frame>Screening until 30 days after discontinuation of dosing or subject's participation</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Thrombosis</condition>
  <arm_group>
    <arm_group_label>Mild Hepatic Subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects are given a single dose of BMS-986177</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate Hepatic Subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects are given a single dose of BMS-986177</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Match Subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects are given a single dose of BMS-986177</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-986177</intervention_name>
    <description>Single oral dose</description>
    <arm_group_label>Healthy Match Subjects</arm_group_label>
    <arm_group_label>Mild Hepatic Subjects</arm_group_label>
    <arm_group_label>Moderate Hepatic Subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women not of childbearing potential (WNOCBP) and males. Women must have documented&#xD;
             proof they are not of childbearing potential&#xD;
&#xD;
          -  BMI of 20.0 to 38.0 kg/m2, inclusive&#xD;
&#xD;
          -  Hepatic subjects classified as Child-Pugh mild (Class A) or Child-Pugh moderate (Class&#xD;
             B) who have had no significant change to disease status in past 6 months and are on&#xD;
             stable treatment regimen&#xD;
&#xD;
          -  Healthy subjects must not have clinically significant deviations from normal in&#xD;
             medical history, physical exam, ECGs, vital signs or clinical lab values&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of coagulopathy, prolonged or unexplained clinically significant bleeding, or&#xD;
             frequent unexplained bruising or thrombus formation&#xD;
&#xD;
          -  Use of corticosteroids, nonsteroidal anti-inflammatory compounds, aspirin or other&#xD;
             antiplatelet agents or anticoagulants within 2 weeks of dosing&#xD;
&#xD;
          -  Healthy subjects must not have used tobacco or have a history of drug or alcohol abuse&#xD;
             within the last 6 months&#xD;
&#xD;
          -  Subjects must not have a current or recent (within 3 months) GI disease that increases&#xD;
             participant risk of GI bleeding or interferes with absorption of the study drug&#xD;
&#xD;
        Other protocol defined inclusion and exclusion criteria may 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>Orlando 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>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <link>
    <url>https://www.bmsstudyconnect.com/s/US/English/USenHome</url>
    <description>BMS Clinical Trial Education Resource</description>
  </link>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>November 12, 2018</last_update_submitted>
  <last_update_submitted_qc>November 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 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>Thrombosis</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/NCT02982707
org study id: CV010-013
nct id: NCT02982707
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
A single oral dose of BMS-986177 administered to subjects of mild hepatic impairment,
      moderate hepatic impairment and healthy matched subjects to evaluate pharmacokinetics,
      safety, and tolerability in these subjects
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum observed plasma concentration (Cmax) of BMS-986177
time frame: Up to 5 days
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-987177
time frame: Up to 5 days
measure: Area under the plasma concentration-time curve from time zero to the time the last quantifiable concentration (AUC(0-T)) of BMS-986177
time frame: Up to 5 days
measure: Area under the plasma concentration-time curve from time zero to (AUC(0-72)) of BMS-986177
time frame: Up to 5 days
measure: Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation
time frame: Screening until 30 days after discontinuation of dosing or subject's participation
measure: Number of participants with clinical laboratory abnormalities
time frame: Screening until 30 days after discontinuation of dosing or subject's participation
measure: Number of participants with clinically significant changes in electrical activity of the heart measured by electrocardiogram (ECG)
time frame: Screening until 30 days after discontinuation of dosing or subject's participation
measure: Number of participants with vital sign abnormalities
time frame: Screening until 30 days after discontinuation of dosing or subject's participation
arm group label: Mild Hepatic Subjects
arm group type: Experimental
description: Subjects are given a single dose of BMS-986177
arm group label: Moderate Hepatic Subjects
arm group type: Experimental
description: Subjects are given a single dose of BMS-986177
arm group label: Healthy Match Subjects
arm group type: Experimental
description: Subjects are given a single dose of BMS-986177
intervention type: Drug
intervention name: BMS-986177
description: Single oral dose
arm group label: Healthy Match Subjects
arm group label: Mild Hepatic Subjects
arm group label: Moderate Hepatic 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: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.bmsstudyconnect.com/s/US/English/USenHome
description: BMS Clinical Trial Education Resource
responsible party type: Sponsor
mesh term: Thrombosis