<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/NCT01732848</url>
  </required_header>
  <id_info>
    <org_study_id>AI472-013</org_study_id>
    <nct_id>NCT01732848</nct_id>
  </id_info>
  <brief_title>A Follow-up Evaluation for Safety in Subjects Who Participated in a Phase 1 Study With BMS-986094 (INX-08189)</brief_title>
  <official_title>A Follow-up Evaluation for Safety in Subjects Who Participated in a Phase 1 Study With BMS-986094 (INX-08189)</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>
      The purpose of this study is to determine the rate of kidney or heart impairment, if any, in&#xD;
      subjects who received BMS-986094 (INX-08189) in Phase 1 clinical trials&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of renal impairment among subjects exposed to BMS-986094 in the Phase 1 program that meet the predefined criteria for impaired renal function and require referral to a nephrologist</measure>
    <time_frame>Up to Day 90</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of cardiac impairment among subjects exposed to BMS-986094 in the Phase 1 program that meet the predefined criteria for impaired cardiac function and require referral to a cardiologist</measure>
    <time_frame>Up to Day 90</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in the electrocardiographic parameters observed in association with prior exposure to single and multiple oral doses of BMS-986094 compared to pre-exposure electrocardiograms (ECGs)</measure>
    <time_frame>Baseline (pre-dose Day 1 ECG from parent study) and By Day 30</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abnormalities in cardiac ejection fraction (EF) as determined by trans-thoracic echocardiogram that may be associated with prior exposure to single or multiple oral doses of BMS-986094</measure>
    <time_frame>By Day 90</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abnormalities in B-type-natriuretic peptide (BNP) levels that may be associated with prior exposure to single or multiple oral doses of BMS-986094</measure>
    <time_frame>By Day 30</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in serum creatinine levels compared to pre-exposure levels that may be associated with prior exposure to single or multiple oral doses of BMS-986094</measure>
    <time_frame>Baseline (Day 1 from parent study) and By Day 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abnormalities in urinary albumin excretion that may be associated with prior exposure to single or multiple oral doses of BMS-986094</measure>
    <time_frame>By Day 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of signs, symptoms or medical history suggestive of heart failure or renal failure that may have been observed since last exposure to BMS-986094</measure>
    <time_frame>By Day 90</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abnormalities in creatine phosphokinase (CPK) and creatine phosphokinase-metabolic (CPK-MB) levels that may be associated with prior exposure to single or multiple doses of BMS-986094</measure>
    <time_frame>By Day 30</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abnormalities in troponin levels that may be associated with prior exposure to single or multiple doses of BMS-986094</measure>
    <time_frame>By Day 30</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">113</enrollment>
  <condition>Healthy</condition>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>Subjects treated with BMS-986094/INX-08189</arm_group_label>
    <description>Subjects who participated in a clinical trial in which at least 1 dose of BMS-986094/INX-08189 was administered</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects treated with Placebo matching BMS-986094/INX-08189</arm_group_label>
    <description>Subjects who participated in a clinical trial in which at least 1 dose of Placebo matching BMS-986094/INX-08189 was administered</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-986094/INX-08189</intervention_name>
    <arm_group_label>Subjects treated with BMS-986094/INX-08189</arm_group_label>
    <other_name>Observational study - No Intervention subjects were previously treated with BMS-986094/INX-08189</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo matching BMS-986094/INX-08189</intervention_name>
    <arm_group_label>Subjects treated with Placebo matching BMS-986094/INX-08189</arm_group_label>
    <other_name>Observational study - No Intervention subjects were previously treated with Placebo matching BMS-986094/INX-08189</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects who participated in prior trial with BMS-986094/INX-08189 and received at least 1&#xD;
        dose of INX-08189 or placebo in trials INH-189-002 or INH-189-006&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy and hepatitis C virus (HCV)-infected subjects who participated in prior Phase&#xD;
             1 trial with BMS-986094/INX-08189 and:&#xD;
&#xD;
               1. Received at least 1 dose of INX-08189 or&#xD;
&#xD;
               2. Received placebo in studies for HCV-infected subjects (INH-189-002 or&#xD;
                  INH-189-006)&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</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>Local Institution</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prism Research</name>
      <address>
        <city>St. Paul</city>
        <state>Minnesota</state>
        <zip>55114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Orleans Center For Clinical Research - Knoxville</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>San Juan</city>
        <zip>00927</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>November 20, 2012</study_first_submitted>
  <study_first_submitted_qc>November 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <last_update_submitted>August 13, 2014</last_update_submitted>
  <last_update_submitted_qc>August 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Volunteers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</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/NCT01732848
org study id: AI472-013
nct id: NCT01732848
lead sponsor: 
has dmc: No
The purpose of this study is to determine the rate of kidney or heart impairment, if any, in
      subjects who received BMS-986094 (INX-08189) in Phase 1 clinical trials
observational model: Cohort
time perspective: Cross-Sectional
measure: Rate of renal impairment among subjects exposed to BMS-986094 in the Phase 1 program that meet the predefined criteria for impaired renal function and require referral to a nephrologist
time frame: Up to Day 90
measure: Rate of cardiac impairment among subjects exposed to BMS-986094 in the Phase 1 program that meet the predefined criteria for impaired cardiac function and require referral to a cardiologist
time frame: Up to Day 90
measure: Changes in the electrocardiographic parameters observed in association with prior exposure to single and multiple oral doses of BMS-986094 compared to pre-exposure electrocardiograms (ECGs)
time frame: Baseline (pre-dose Day 1 ECG from parent study) and By Day 30
measure: Abnormalities in cardiac ejection fraction (EF) as determined by trans-thoracic echocardiogram that may be associated with prior exposure to single or multiple oral doses of BMS-986094
time frame: By Day 90
measure: Abnormalities in B-type-natriuretic peptide (BNP) levels that may be associated with prior exposure to single or multiple oral doses of BMS-986094
time frame: By Day 30
measure: Changes in serum creatinine levels compared to pre-exposure levels that may be associated with prior exposure to single or multiple oral doses of BMS-986094
time frame: Baseline (Day 1 from parent study) and By Day 14
measure: Abnormalities in urinary albumin excretion that may be associated with prior exposure to single or multiple oral doses of BMS-986094
time frame: By Day 7
measure: Presence of signs, symptoms or medical history suggestive of heart failure or renal failure that may have been observed since last exposure to BMS-986094
time frame: By Day 90
measure: Abnormalities in creatine phosphokinase (CPK) and creatine phosphokinase-metabolic (CPK-MB) levels that may be associated with prior exposure to single or multiple doses of BMS-986094
time frame: By Day 30
measure: Abnormalities in troponin levels that may be associated with prior exposure to single or multiple doses of BMS-986094
time frame: By Day 30
arm group label: Subjects treated with BMS-986094/INX-08189
description: Subjects who participated in a clinical trial in which at least 1 dose of BMS-986094/INX-08189 was administered
arm group label: Subjects treated with Placebo matching BMS-986094/INX-08189
description: Subjects who participated in a clinical trial in which at least 1 dose of Placebo matching BMS-986094/INX-08189 was administered
intervention type: Drug
intervention name: BMS-986094/INX-08189
arm group label: Subjects treated with BMS-986094/INX-08189
other name: Observational study - No Intervention subjects were previously treated with BMS-986094/INX-08189
intervention type: Drug
intervention name: Placebo matching BMS-986094/INX-08189
arm group label: Subjects treated with Placebo matching BMS-986094/INX-08189
other name: Observational study - No Intervention subjects were previously treated with Placebo matching BMS-986094/INX-08189
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
facility: 
facility: 
facility: 
facility: 
facility: 
country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Hepatitis C