<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/NCT01665404</url>
  </required_header>
  <id_info>
    <org_study_id>BP28250</org_study_id>
    <secondary_id>2012-000772-42</secondary_id>
    <nct_id>NCT01665404</nct_id>
  </id_info>
  <brief_title>A Study of the Effect of Fluvoxamine on the Pharmacokinetics of RO4917523 in Healthy Volunteers</brief_title>
  <official_title>A Single-Center, Open-Label, One-Sequence, Crossover Study to Investigate the Effects of Multiple Doses of Fluvoxamine on the Pharmacokinetics of a Single Dose RO4917523 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 single-center, open-label, cross-over study will evaluate the effect of fluvoxamine on&#xD;
      the pharmacokinetics of RO4917523 in healthy volunteers. Healthy volunteers will receive a&#xD;
      single dose of RO4917523 alone and in combination with multiple doses of fluvoxamine in a&#xD;
      cross-over design. The anticipated time on study treatment is 40 days.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 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>Crossover Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics: Area under the concentration time curve</measure>
    <time_frame>Period 1: Pre-dose and up to Day 14, Period 2: pre-dose and up to Day 26</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety: incidence of adverse events</measure>
    <time_frame>9 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Healthy Volunteer</condition>
  <arm_group>
    <arm_group_label>Dosing Period 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Dosing Period 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluvoxamine</intervention_name>
    <description>Multiple doses of fluvoxamine</description>
    <arm_group_label>Dosing Period 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RO4917523</intervention_name>
    <description>Single dose of RO4917523</description>
    <arm_group_label>Dosing Period 1</arm_group_label>
    <arm_group_label>Dosing Period 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers, 18-65 years of age inclusive&#xD;
&#xD;
          -  Non-smokers&#xD;
&#xD;
          -  Body mass index (BMI) between 18 and 30 mg/m2 inclusive&#xD;
&#xD;
          -  Women who are not menopausal or surgically sterile agree to use two adequate methods&#xD;
             of contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of any active or chronic disease&#xD;
&#xD;
          -  History of any significant disease (e.g., cardiovascular, hepatic, renal) or cancer&#xD;
             History or presence of clinically significant psychiatric condition&#xD;
&#xD;
          -  Any condition or disease that would render the volunteer unsuitable for the study,&#xD;
             place the volunteer at undue risk or interfere with the ability of the volunteer to&#xD;
             complete the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 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>Rennes</city>
        <zip>35042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 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>Fluvoxamine</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/NCT01665404
org study id: BP28250
secondary id: 2012-000772-42
nct id: NCT01665404
lead sponsor: 
This single-center, open-label, cross-over study will evaluate the effect of fluvoxamine on
      the pharmacokinetics of RO4917523 in healthy volunteers. Healthy volunteers will receive a
      single dose of RO4917523 alone and in combination with multiple doses of fluvoxamine in a
      cross-over design. The anticipated time on study treatment is 40 days.
allocation: Non-Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: Pharmacokinetics: Area under the concentration time curve
time frame: Period 1: Pre-dose and up to Day 14, Period 2: pre-dose and up to Day 26
measure: Safety: incidence of adverse events
time frame: 9 weeks
arm group label: Dosing Period 1
arm group type: Experimental
arm group label: Dosing Period 2
arm group type: Experimental
intervention type: Drug
intervention name: Fluvoxamine
description: Multiple doses of fluvoxamine
arm group label: Dosing Period 2
intervention type: Drug
intervention name: RO4917523
description: Single dose of RO4917523
arm group label: Dosing Period 1
arm group label: Dosing Period 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
country: France
responsible party type: Sponsor
mesh term: Fluvoxamine