<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/NCT01708889</url>
  </required_header>
  <id_info>
    <org_study_id>AI452-019</org_study_id>
    <nct_id>NCT01708889</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic Study of BMS-914143 in Participants With Normal Renal Function and Mild, Moderate, Severe and End-stage Renal Dysfunction</brief_title>
  <acronym>PK</acronym>
  <official_title>An Open-label, Single Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-914143 in Subject With Normal Renal Function and Subjects With Mild, Moderate, Severe, and End-stage Renal Dysfunction</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 effect of renal impairment on pharmacokinetics&#xD;
      (PK) of BMS-914143.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary purpose: Protocol designed to evaluate the effect of renal impairment on&#xD;
      pharmacokinetics of BMS-914143&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the serum concentration-time curve from time 0 extrapolated to infinity [AUC(INF)] of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction</measure>
    <time_frame>18 time points up to Day 29</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the serum concentration-time curve from time 0 to the time of last quantifiable concentration [AUC(0-T)] of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction</measure>
    <time_frame>18 time points up to Day 29</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum observed serum concentration (Cmax) of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction</measure>
    <time_frame>18 time points up to Day 29</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent volume of distribution (Vz/F) of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction</measure>
    <time_frame>18 time points up to Day 29</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Total body clearance (CLT/F) of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction</measure>
    <time_frame>18 time points up to Day 29</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to maximum observed serum concentration (Tmax) using serum levels of Lambda</measure>
    <time_frame>18 time points up to Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Half life (T-HALF) using serum levels of Lambda</measure>
    <time_frame>18 time points up to Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity assessed by serum levels of anti-Lambda antibodies</measure>
    <time_frame>5 time points up to Day 43</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by Vital signs measurements, electrocardiograms (ECGs), clinical laboratory tests, marked laboratory abnormalities, physical measurements, and adverse events (AEs)</measure>
    <time_frame>Up to Day 43</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious adverse events (SAEs) Safety assessed by Vital signs measurements, electrocardiograms (ECGs), clinical laboratory tests, marked laboratory abnormalities, physical measurements, and adverse events (AEs)</measure>
    <time_frame>Approximately up to Day 73</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Chronic Hepatitis B Virus Infection</condition>
  <condition>Chronic Hepatitis C Virus Infection</condition>
  <arm_group>
    <arm_group_label>Group 1: BMS-914143 (eGFR ≥ 80 mL/min/1.73 m2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with normal renal function with eGFR ≥ 80 mL/min/1.73 m2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: BMS-914143 (eGFR 60 to 79 mL/min/1.73 m2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with mild renal dysfunction with eGFR 60 to 79 mL/min/1.73 m2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3: BMS-914143 (eGFR 30 to 59 mL/min/1.73 m2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with moderate renal dysfunction with eGFR 30 to 59 mL/min/1.73 m2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4: BMS-914143 (eGFR 15 to 29 mL/min/1.73 m2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with severe renal dysfunction with eGFR 15 to 29 mL/min/1.73 m2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 5: BMS-914143 (eGFR &lt; 15 mL/min/1.73 m2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with end-stage renal dysfunction with eGFR &lt; 15 mL/min/1.73 m2 (on hemodialysis [HD] or non-HD)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>BMS-914143 (Peginterferon Lambda-1a)</intervention_name>
    <arm_group_label>Group 1: BMS-914143 (eGFR ≥ 80 mL/min/1.73 m2)</arm_group_label>
    <arm_group_label>Group 2: BMS-914143 (eGFR 60 to 79 mL/min/1.73 m2)</arm_group_label>
    <arm_group_label>Group 3: BMS-914143 (eGFR 30 to 59 mL/min/1.73 m2)</arm_group_label>
    <arm_group_label>Group 4: BMS-914143 (eGFR 15 to 29 mL/min/1.73 m2)</arm_group_label>
    <arm_group_label>Group 5: BMS-914143 (eGFR &lt; 15 mL/min/1.73 m2)</arm_group_label>
    <other_name>Lambda</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal renal function or mild, moderate, severe or end-stage renal dysfunction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of uncontrolled or unstable cardiovascular, respiratory, gastrointestinal,&#xD;
             hepatic, endocrine, hematopoietic, psychiatric or neurological conditions within 6&#xD;
             months of Lambda administration&#xD;
&#xD;
          -  History of chronic liver disease including cirrhosis, hepatitis B virus (HBV),&#xD;
             hepatitis C virus (HCV), primary biliary cirrhosis, etc&#xD;
&#xD;
          -  History of central nervous system or neuro-psychiatric disease. Subjects with severe&#xD;
             depression and/or other uncontrolled psychiatric conditions should not be enrolled in&#xD;
             this study&#xD;
&#xD;
          -  History of of suicide attempt within the 5 years preceding BMS-914143 administration&#xD;
&#xD;
          -  Inability to tolerate subcutaneous injections&#xD;
&#xD;
          -  Donation of &gt;400 mL of blood within 8 weeks or plasma within 4 weeks of planned dosing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 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 Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33014-3616</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>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_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.bms.com/studyconnect/Pages/home.aspx</url>
    <description>BMS clinical trial educational resource</description>
  </link>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>June 4, 2013</last_update_submitted>
  <last_update_submitted_qc>June 4, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 5, 2013</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>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Virus Diseases</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
    <mesh_term>Hepatitis B, Chronic</mesh_term>
    <mesh_term>Herpesviridae Infections</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Hepatitis, Chronic</mesh_term>
    <mesh_term>Renal Insufficiency</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/NCT01708889
org study id: AI452-019
nct id: NCT01708889
lead sponsor: 
has dmc: No
The purpose of this study is to determine the effect of renal impairment on pharmacokinetics
      (PK) of BMS-914143.
Primary purpose: Protocol designed to evaluate the effect of renal impairment on
      pharmacokinetics of BMS-914143
allocation: Non-Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Area under the serum concentration-time curve from time 0 extrapolated to infinity [AUC(INF)] of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction
time frame: 18 time points up to Day 29
measure: Area under the serum concentration-time curve from time 0 to the time of last quantifiable concentration [AUC(0-T)] of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction
time frame: 18 time points up to Day 29
measure: Maximum observed serum concentration (Cmax) of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction
time frame: 18 time points up to Day 29
measure: Apparent volume of distribution (Vz/F) of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction
time frame: 18 time points up to Day 29
measure: Total body clearance (CLT/F) of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction
time frame: 18 time points up to Day 29
measure: Time to maximum observed serum concentration (Tmax) using serum levels of Lambda
time frame: 18 time points up to Day 29
measure: Half life (T-HALF) using serum levels of Lambda
time frame: 18 time points up to Day 29
measure: Immunogenicity assessed by serum levels of anti-Lambda antibodies
time frame: 5 time points up to Day 43
measure: Safety assessed by Vital signs measurements, electrocardiograms (ECGs), clinical laboratory tests, marked laboratory abnormalities, physical measurements, and adverse events (AEs)
time frame: Up to Day 43
measure: Serious adverse events (SAEs) Safety assessed by Vital signs measurements, electrocardiograms (ECGs), clinical laboratory tests, marked laboratory abnormalities, physical measurements, and adverse events (AEs)
time frame: Approximately up to Day 73
arm group label: Group 1: BMS-914143 (eGFR ≥ 80 mL/min/1.73 m2)
arm group type: Experimental
description: BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with normal renal function with eGFR ≥ 80 mL/min/1.73 m2
arm group label: Group 2: BMS-914143 (eGFR 60 to 79 mL/min/1.73 m2)
arm group type: Experimental
description: BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with mild renal dysfunction with eGFR 60 to 79 mL/min/1.73 m2
arm group label: Group 3: BMS-914143 (eGFR 30 to 59 mL/min/1.73 m2)
arm group type: Experimental
description: BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with moderate renal dysfunction with eGFR 30 to 59 mL/min/1.73 m2
arm group label: Group 4: BMS-914143 (eGFR 15 to 29 mL/min/1.73 m2)
arm group type: Experimental
description: BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with severe renal dysfunction with eGFR 15 to 29 mL/min/1.73 m2
arm group label: Group 5: BMS-914143 (eGFR < 15 mL/min/1.73 m2)
arm group type: Experimental
description: BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with end-stage renal dysfunction with eGFR < 15 mL/min/1.73 m2 (on hemodialysis [HD] or non-HD)
intervention type: Biological
intervention name: BMS-914143 (Peginterferon Lambda-1a)
arm group label: Group 1: BMS-914143 (eGFR ≥ 80 mL/min/1.73 m2)
arm group label: Group 2: BMS-914143 (eGFR 60 to 79 mL/min/1.73 m2)
arm group label: Group 3: BMS-914143 (eGFR 30 to 59 mL/min/1.73 m2)
arm group label: Group 4: BMS-914143 (eGFR 15 to 29 mL/min/1.73 m2)
arm group label: Group 5: BMS-914143 (eGFR < 15 mL/min/1.73 m2)
other name: Lambda
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 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 educational resource
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Hepatitis A
mesh term: Virus Diseases
mesh term: Hepatitis C
mesh term: Hepatitis B
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis B, Chronic
mesh term: Herpesviridae Infections
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Renal Insufficiency