<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/NCT01701739</url>
  </required_header>
  <id_info>
    <org_study_id>BP25562</org_study_id>
    <secondary_id>2012-002269-36</secondary_id>
    <nct_id>NCT01701739</nct_id>
  </id_info>
  <brief_title>A Pharmacokinetics Study of Aleglitazar in Combination With Digoxin in Healthy Volunteers</brief_title>
  <official_title>An Open-label, Two-period Fixed-sequence Study to Investigate the Effect of Multiple Doses of Aleglitazar on a Single Dose of Digoxin in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This open-label, two-period, fixed-sequence study will investigate the pharmacokinetics and&#xD;
      safety of multiple doses of aleglitazar on a single dose of digoxin in healthy volunteers. In&#xD;
      period 1, volunteers will receive a single dose of digoxin, in period 2 volunteers will&#xD;
      receive multiple doses of aleglitazar and a single dose of digoxin. The anticipated time on&#xD;
      study treatment is one month.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 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>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics: Area under the concentration time curve</measure>
    <time_frame>Approximately 1 month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: maximum plasma concentration</measure>
    <time_frame>Approximately 1 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Elimination half-life</measure>
    <time_frame>Approximately 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Time to maximum plasma concentration</measure>
    <time_frame>Approximately 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Renal clearance</measure>
    <time_frame>Approximately 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Apparent volume of distribution</measure>
    <time_frame>Approximately 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Apparent clearance</measure>
    <time_frame>Approximately 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Amount excreted in the urine</measure>
    <time_frame>Approximately 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Fraction of drug excreted in urine</measure>
    <time_frame>Approximately 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: Incidence of adverse events</measure>
    <time_frame>Approximately 2 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Healthy Volunteer</condition>
  <arm_group>
    <arm_group_label>aleglitazar / digoxin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>aleglitazar</intervention_name>
    <description>Multiple doses of aleglitazar</description>
    <arm_group_label>aleglitazar / digoxin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>digoxin</intervention_name>
    <description>Single dose of digoxin</description>
    <arm_group_label>aleglitazar / digoxin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers, 18-55 years of age, inclusive&#xD;
&#xD;
          -  Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive.&#xD;
&#xD;
          -  Females must be either surgically sterile or post-menopausal for at least one year or,&#xD;
             if they are of child-bearing potential, must use two acceptable methods of&#xD;
             contracepetion&#xD;
&#xD;
          -  Volunteer normally drinks no more than three cups of coffee/tea/caffeinated soft&#xD;
             drinks per day and is willing to stop drinking coffee/tea/caffeinated soft drinks&#xD;
             during the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any clinically relevant abnormal laboratory test results at screening or on Day -1&#xD;
&#xD;
          -  Has taken any prescribed or herbal/over the counter medication within 2 weeks prior to&#xD;
             the first dosing&#xD;
&#xD;
          -  A history of clinically significant gastro-intestinal, cardiovascular,&#xD;
             musculoskeletal, endocrine, hematological, psychiatric, renal, hepatic,&#xD;
             bronchopulmonary or neurological conditions or lipid metabolism disorders.&#xD;
&#xD;
          -  Infection with human immunodeficiency virus (HIV), hepatitis B, hepatitis C&#xD;
&#xD;
          -  An average alcohol intake of more than 14 units per week&#xD;
&#xD;
          -  A known permanent or unexplained elevation of serum transaminases &gt; 1.5 times the&#xD;
             upper limit of normal&#xD;
&#xD;
          -  A positive screen for drugs of abuse&#xD;
&#xD;
          -  Acute infection requiring treatment within 4 weeks prior to screening&#xD;
&#xD;
          -  Diagnosed or treated malignancy within the past 5 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>November 1, 2016</last_update_submitted>
  <last_update_submitted_qc>November 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Digoxin</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/NCT01701739
org study id: BP25562
secondary id: 2012-002269-36
nct id: NCT01701739
lead sponsor: 
This open-label, two-period, fixed-sequence study will investigate the pharmacokinetics and
      safety of multiple doses of aleglitazar on a single dose of digoxin in healthy volunteers. In
      period 1, volunteers will receive a single dose of digoxin, in period 2 volunteers will
      receive multiple doses of aleglitazar and a single dose of digoxin. The anticipated time on
      study treatment is one month.
allocation: Non-Randomized
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Pharmacokinetics: Area under the concentration time curve
time frame: Approximately 1 month
measure: Pharmacokinetics: maximum plasma concentration
time frame: Approximately 1 month
measure: Pharmacokinetics: Elimination half-life
time frame: Approximately 1 month
measure: Pharmacokinetics: Time to maximum plasma concentration
time frame: Approximately 1 month
measure: Pharmacokinetics: Renal clearance
time frame: Approximately 1 month
measure: Pharmacokinetics: Apparent volume of distribution
time frame: Approximately 1 month
measure: Pharmacokinetics: Apparent clearance
time frame: Approximately 1 month
measure: Pharmacokinetics: Amount excreted in the urine
time frame: Approximately 1 month
measure: Pharmacokinetics: Fraction of drug excreted in urine
time frame: Approximately 1 month
measure: Safety: Incidence of adverse events
time frame: Approximately 2 months
arm group label: aleglitazar / digoxin
arm group type: Experimental
intervention type: Drug
intervention name: aleglitazar
description: Multiple doses of aleglitazar
arm group label: aleglitazar / digoxin
intervention type: Drug
intervention name: digoxin
description: Single dose of digoxin
arm group label: aleglitazar / digoxin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Digoxin