<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/NCT01711775</url>
  </required_header>
  <id_info>
    <org_study_id>BP25230</org_study_id>
    <nct_id>NCT01711775</nct_id>
  </id_info>
  <brief_title>A Pharmacokinetic Study of Aleglitazar in Healthy Chinese Volunteers</brief_title>
  <official_title>A Single-center, Non-randomized, Open-label Study to Assess the Pharmacokinetics of Aleglitazar (RO0728804) After Administration of Single and Multiple Oral Doses of 150 µg Tablet in Healthy Chinese 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 single-center, non-randomized, open-label study will assess the pharmacokinetics of&#xD;
      aleglitazar after administration of single and multiple oral doses in healthy Chinese&#xD;
      volunteers. Subjects will receive a single oral dose of aleglitazar on Day 1 and repeated&#xD;
      oral doses once daily from Day 5 to Day 14. Anticipated time on study, including screening&#xD;
      and a 2-week follow-up, is up to 8 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 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: Day 14 (steady-state) maximum concentration (Cmax)</measure>
    <time_frame>Day 14 pre-dose and up to 24 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: Day 14 (steady-state) area under the concentration-time curve (AUC 0-24)</measure>
    <time_frame>Day 14 pre-dose and up to 24 hours post-dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Maximum concentration (Cmax)</measure>
    <time_frame>18 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single-dose pharmacokinetics: Time to maximum observed plasma concentration (tmax)</measure>
    <time_frame>up to 5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single-dose pharmacokinetics: Half-life (t1/2)</measure>
    <time_frame>up to 5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single-dose pharmacokinetics: Area under the concentration-time curve (AUC)</measure>
    <time_frame>up to 5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Apparent oral plasma clearance (CL/F)</measure>
    <time_frame>18 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Apparent volume of distribution (VZ/F)</measure>
    <time_frame>18 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Accumulation index (Rac)</measure>
    <time_frame>18 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: Incidence of adverse events</measure>
    <time_frame>approximately 10 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</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 oral dose Day 1, repeated oral dose once daily Days 5-14</description>
    <arm_group_label>Aleglitazar</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy female and male Chinese volunteers, 18 to 45 years of age inclusive at&#xD;
             screening&#xD;
&#xD;
          -  Subjects have to be healthy as determined by medical history, physical examination,&#xD;
             vital signs, 12-lead ECG, and clinical laboratory measurements performed at screening&#xD;
&#xD;
          -  Body mass index (BMI) 19 to 24 kg/m2 inclusive&#xD;
&#xD;
          -  Female subjects who are not surgically sterile must be willing to use effective method&#xD;
             of contraception as defined by protocol throughout the study and for 30 days after the&#xD;
             last dosing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any significant allergic reactions or multiple allergies&#xD;
&#xD;
          -  Diagnosed or treated malignancy (except for treated cases of basal skin cancer or in&#xD;
             situ carcinoma of the cervix) within the past 5 years&#xD;
&#xD;
          -  Any major illness within 2 months prior to first dosing or febrile illness within 14&#xD;
             days prior to first dosing&#xD;
&#xD;
          -  Positive for hepatitis B, hepatitis C or HIV infection&#xD;
&#xD;
          -  Any clinically relevant history of alcohol and/or other substance abuse or addiction&#xD;
             within the last 2 years&#xD;
&#xD;
          -  Pregnant or lactating women, or women who have a positive pregnancy test&#xD;
&#xD;
          -  Regular smoker with consumption of more than 10 cigarettes per day or equivalent&#xD;
             amount of tobacco&#xD;
&#xD;
          -  Participation in an investigational drug or device study within 3 months prior to the&#xD;
             first dosing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 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>Beijing</city>
        <zip>100083</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 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>
  <!-- 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/NCT01711775
org study id: BP25230
nct id: NCT01711775
lead sponsor: 
This single-center, non-randomized, open-label study will assess the pharmacokinetics of
      aleglitazar after administration of single and multiple oral doses in healthy Chinese
      volunteers. Subjects will receive a single oral dose of aleglitazar on Day 1 and repeated
      oral doses once daily from Day 5 to Day 14. Anticipated time on study, including screening
      and a 2-week follow-up, is up to 8 weeks.
allocation: Non-Randomized
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Pharmacokinetics: Day 14 (steady-state) maximum concentration (Cmax)
time frame: Day 14 pre-dose and up to 24 hours post-dose
measure: Pharmacokinetics: Day 14 (steady-state) area under the concentration-time curve (AUC 0-24)
time frame: Day 14 pre-dose and up to 24 hours post-dose
measure: Pharmacokinetics: Maximum concentration (Cmax)
time frame: 18 days
measure: Single-dose pharmacokinetics: Time to maximum observed plasma concentration (tmax)
time frame: up to 5 days
measure: Single-dose pharmacokinetics: Half-life (t1/2)
time frame: up to 5 days
measure: Single-dose pharmacokinetics: Area under the concentration-time curve (AUC)
time frame: up to 5 days
measure: Pharmacokinetics: Apparent oral plasma clearance (CL/F)
time frame: 18 days
measure: Pharmacokinetics: Apparent volume of distribution (VZ/F)
time frame: 18 days
measure: Pharmacokinetics: Accumulation index (Rac)
time frame: 18 days
measure: Safety: Incidence of adverse events
time frame: approximately 10 months
arm group label: Aleglitazar
arm group type: Experimental
intervention type: Drug
intervention name: aleglitazar
description: Single oral dose Day 1, repeated oral dose once daily Days 5-14
arm group label: Aleglitazar
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
country: China
responsible party type: Sponsor