<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/NCT02234882</url>
  </required_header>
  <id_info>
    <org_study_id>206276</org_study_id>
    <secondary_id>AI438-048</secondary_id>
    <nct_id>NCT02234882</nct_id>
  </id_info>
  <brief_title>Study on Pharmacokinetics</brief_title>
  <official_title>Effect of BMS-663068 on the Pharmacokinetics of Rosuvastatin</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 effect of the coadministration of multiple doses&#xD;
      of BMS-663068 on the systemic exposure of rosuvastatin.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2014</start_date>
  <completion_date type="Actual">October 31, 2014</completion_date>
  <primary_completion_date type="Actual">October 31, 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum observed plasma concentration (Cmax) of rosuvastatin</measure>
    <time_frame>Days 1 through 13</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) of rosuvastatin</measure>
    <time_frame>Days 1 through 13</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Trough blood samples of BMS-626529 concentration</measure>
    <time_frame>Days 7 through 13</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.</measure>
    <time_frame>40 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Rosuvastatin and BMS-663068</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment A: Rosuvastatin, single dose (SD) Treatment B: BMS-663068 administered on specified days Treatment C: Combination BMS-663068 and Rosuvastatin administered on specified days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin</intervention_name>
    <arm_group_label>Rosuvastatin and BMS-663068</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-663068</intervention_name>
    <arm_group_label>Rosuvastatin and BMS-663068</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed Informed Consent Form&#xD;
&#xD;
               -  Signed written informed consent must be obtained from the subjects in accordance&#xD;
                  with requirements of the study center's IRB or IEC before the initiation of any&#xD;
                  protocol-required procedures.&#xD;
&#xD;
          2. Target Population&#xD;
&#xD;
               -  Healthy subjects as determined by no clinically significant deviation from normal&#xD;
                  in medical history, physical examination findings, vital sign measurements,&#xD;
                  12-lead ECG measurements, and clinical laboratory test results.&#xD;
&#xD;
          3. Age and Reproductive Status&#xD;
&#xD;
               -  Men and women of non-childbearing potential, ages 18 to 50 years, inclusive.&#xD;
                  Women must have documented proof that they are not of childbearing potential.&#xD;
                  Women must not be breastfeeding.&#xD;
&#xD;
               -  Males who are sexually active with women of childbearing potential (WOCBP) must&#xD;
                  agree to follow instructions for method(s) of contraception for the duration of&#xD;
                  treatment with study drug(s).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are of childbearing potential or breastfeeding&#xD;
&#xD;
          -  Any significant acute or chronic medical illness&#xD;
&#xD;
          -  History of rhabdomyolysis or biliary disorders, including Gilbert's disease or&#xD;
             Dubin-Johnson disease&#xD;
&#xD;
          -  Smokers (those who currently smoke, as well as those who have stopped smoking less&#xD;
             than 6 months prior to the start of study drug administration)&#xD;
&#xD;
          -  Alcohol intake exceeding 2 standard drinks per days; however, no alcohol is allowed 1&#xD;
             week prior to the start of study drug administration and for the duration of the study&#xD;
&#xD;
          -  Any other sound medical, psychiatric, and/or social reason as determined by the&#xD;
             investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</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, MD</last_name>
    <role>Study Director</role>
    <affiliation>ViiV Healthcare</affiliation>
  </overall_official>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 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>Fostemsavir</mesh_term>
    <mesh_term>Rosuvastatin Calcium</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/NCT02234882
org study id: 206276
secondary id: AI438-048
nct id: NCT02234882
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to assess the effect of the coadministration of multiple doses
      of BMS-663068 on the systemic exposure of rosuvastatin.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Maximum observed plasma concentration (Cmax) of rosuvastatin
time frame: Days 1 through 13
measure: Area under the concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) of rosuvastatin
time frame: Days 1 through 13
measure: Trough blood samples of BMS-626529 concentration
time frame: Days 7 through 13
measure: Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.
time frame: 40 days
arm group label: Rosuvastatin and BMS-663068
arm group type: Experimental
description: Treatment A: Rosuvastatin, single dose (SD) Treatment B: BMS-663068 administered on specified days Treatment C: Combination BMS-663068 and Rosuvastatin administered on specified days
intervention type: Drug
intervention name: Rosuvastatin
arm group label: Rosuvastatin and BMS-663068
intervention type: Drug
intervention name: BMS-663068
arm group label: Rosuvastatin and BMS-663068
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: ViiV Clinical Trials, MD
role: Study Director
affiliation: ViiV Healthcare
responsible party type: Sponsor
mesh term: HIV Infections
mesh term: Fostemsavir
mesh term: Rosuvastatin Calcium