<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/NCT01679639</url>
  </required_header>
  <id_info>
    <org_study_id>BP25561</org_study_id>
    <secondary_id>2012-002274-31</secondary_id>
    <nct_id>NCT01679639</nct_id>
  </id_info>
  <brief_title>A Study to Investigate the Effects of Rifampicin on the Pharmacokinetics of Aleglitazar in Healthy Volunteers</brief_title>
  <official_title>An Open-label, Fixed-sequence, Three-period, Single Group Study to Investigate the Effects of Rifampicin as an OATP1B1 Inhibitor and a CYP2C8 Inducer on the Pharmacokinetics of Aleglitazar 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, fixed-sequence, three-period, single group study will evaluate the effects&#xD;
      of rifampicin on the pharmacokinetics of aleglitazar in healthy volunteers. Volunteers will&#xD;
      receive single doses of aleglitazar in all three periods and single doses of rifampicin in&#xD;
      periods 1 and 2, and multiple doses in period 3. The anticipated time on study treatment is&#xD;
      up to 14 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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 plasma concentration time curve</measure>
    <time_frame>Period 1 and 2: Predose and days 1 to 5; Period 3: Days 5 to 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety: incidence of adverse events</measure>
    <time_frame>14 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy Volunteer</condition>
  <arm_group>
    <arm_group_label>Aleglitazar</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>aleglitazar</intervention_name>
    <description>Single dose of aleglitazar in Periods 1, 2, 3</description>
    <arm_group_label>Aleglitazar</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>rifampicin</intervention_name>
    <description>Single dose in Periods 1 and 2; multiple doses in Period 3</description>
    <arm_group_label>Aleglitazar</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers, aged 18 to 55 years inclusive at the time of screening&#xD;
&#xD;
          -  Body mass index (BMI) between 18.0 and 35.0 kg/m2 inclusive&#xD;
&#xD;
          -  Females must be surgically sterile or use two acceptable methods of contraception&#xD;
&#xD;
          -  Non-smoker or currently smoking less than five cigarettes/day and willing to abstain&#xD;
             from smoking during the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any clinically relevant abnormal laboratory test results at screening or on Day -1 of&#xD;
             all periods, as judged by the Investigator&#xD;
&#xD;
          -  A history of clinically significant disorders (e.g., gastro-intestinal,&#xD;
             cardiovascular, hepatic)&#xD;
&#xD;
          -  Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C&#xD;
&#xD;
          -  An average alcohol intake of more than 14 units per week&#xD;
&#xD;
          -  Volunteers diagnosed, or suspected of having porphyria, and subjects with first degree&#xD;
             relatives diagnosed, or suspected of having porphyria&#xD;
&#xD;
          -  Diagnosis of Gilberts Syndrome&#xD;
&#xD;
          -  A positive screen for drugs of abuse at screening or on admission to the clinical unit&#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>September 1, 2012</study_first_submitted>
  <study_first_submitted_qc>September 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 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>Rifampin</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/NCT01679639
org study id: BP25561
secondary id: 2012-002274-31
nct id: NCT01679639
lead sponsor: 
This open-label, fixed-sequence, three-period, single group study will evaluate the effects
      of rifampicin on the pharmacokinetics of aleglitazar in healthy volunteers. Volunteers will
      receive single doses of aleglitazar in all three periods and single doses of rifampicin in
      periods 1 and 2, and multiple doses in period 3. The anticipated time on study treatment is
      up to 14 weeks.
allocation: Non-Randomized
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Pharmacokinetics: Area under the plasma concentration time curve
time frame: Period 1 and 2: Predose and days 1 to 5; Period 3: Days 5 to 12
measure: Safety: incidence of adverse events
time frame: 14 weeks
arm group label: Aleglitazar
arm group type: Experimental
intervention type: Drug
intervention name: aleglitazar
description: Single dose of aleglitazar in Periods 1, 2, 3
arm group label: Aleglitazar
intervention type: Drug
intervention name: rifampicin
description: Single dose in Periods 1 and 2; multiple doses in Period 3
arm group label: Aleglitazar
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: Rifampin