<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/NCT01708616</url>
  </required_header>
  <id_info>
    <org_study_id>BP28318</org_study_id>
    <secondary_id>2012-003231-31</secondary_id>
    <nct_id>NCT01708616</nct_id>
  </id_info>
  <brief_title>A Study of the Combination of Multiple Doses of RO5285119 With a Single Dose of Risperidone in Healthy Volunteers</brief_title>
  <official_title>A Single-center, Randomized, Double-blind, Two-period Crossover Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of the Combination of Multiple Doses of RO5285119 With a Single Dose of Risperidone 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, randomized, double-blind, two-period crossover study will evaluate the&#xD;
      safety, tolerability, pharmacokinetics and pharmacodynamic effects of the combination of&#xD;
      multiple doses of RO5285119 with a single dose of risperidone in healthy volunteers. Subjects&#xD;
      will be randomized to one of 4 treatment sequences of two periods to receive multiple doses&#xD;
      of RO5285119 plus a single dose of risperidone or risperidone placebo or multiple doses of&#xD;
      RO5285119 placebo plus a single dose of risperidone or risperidone placebo, with a washout&#xD;
      period of approximately 3 weeks between treatment periods. Anticipated time on study is up to&#xD;
      12 weeks (from screening through study completion).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Crossover Assignment</intervention_model>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Maximum plasma concentration (Cmax)</measure>
    <time_frame>Pre-dose to 24 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Area under the concentration-time curve (AUC)</measure>
    <time_frame>Pre-dose to 24 hours post-dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety: Incidence of adverse events</measure>
    <time_frame>approximately 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic markers for risperidone: Prolactin levels</measure>
    <time_frame>Pre-dose to 6 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic assessments for risperidone: Level of sedation</measure>
    <time_frame>Pre-dose to 24 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of RO5285119 in combination with single dose risperidone: Maximum plasma concentration (Cmax)</measure>
    <time_frame>Day 1 to Day 18</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of RO5285119 in combination with single dose risperidone: Area under the concentration-time curve (AUC)</measure>
    <time_frame>Day1 to Day 18</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy Volunteer</condition>
  <arm_group>
    <arm_group_label>Placebo + risperidone</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo +placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>RO5285119 + placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>RO5285119 + risperidone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RO5285119</intervention_name>
    <description>multiple doses</description>
    <arm_group_label>RO5285119 + placebo</arm_group_label>
    <arm_group_label>RO5285119 + risperidone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RO5285119 placebo</intervention_name>
    <description>multiple doses</description>
    <arm_group_label>Placebo + risperidone</arm_group_label>
    <arm_group_label>Placebo +placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>risperidone</intervention_name>
    <description>single dose</description>
    <arm_group_label>Placebo + risperidone</arm_group_label>
    <arm_group_label>RO5285119 + risperidone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>risperidone placebo</intervention_name>
    <description>single dose</description>
    <arm_group_label>Placebo +placebo</arm_group_label>
    <arm_group_label>RO5285119 + placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and female adults, 18 - 50 years of age inclusive Healthy status is&#xD;
             defined by absence of evidence of any active or chronic disease following detailed&#xD;
             medical and surgical history and a physical examination including vital signs, 12-lead&#xD;
             ECG, hematology, blood chemistry, serology and urinalysis&#xD;
&#xD;
          -  Body mass index (BMI) 18 to 30 kg/m2 inclusive&#xD;
&#xD;
          -  Women have to be postmenopausal or surgically sterile&#xD;
&#xD;
          -  Male subjects must use a barrier method of contraception for the duration of the study&#xD;
             and for 3 months after last dosing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suspicion of regular consumption of drug of abuse, or history of drug or alcohol abuse&#xD;
&#xD;
          -  Positive for hepatitis B, hepatitis C or HIV infection&#xD;
&#xD;
          -  History of clinically significant hypersensitivity or allergic reactions&#xD;
&#xD;
          -  Disorders of the central nervous system, including psychiatric disorders, behavioural&#xD;
             disturbances, cerebrovascular events, depression, bipolar disorder, migraine,&#xD;
             Parkinson&#xD;
&#xD;
          -  Regular smoker (&gt;5 cigarettes, &gt;3 pipe-fulls, &gt;3 cigars per day)&#xD;
&#xD;
          -  Administration of an investigational drug or device within 3 months prior to first&#xD;
             dosing&#xD;
&#xD;
               -  Hypersensitivity to risperidone or any of its excipients&#xD;
&#xD;
          -  Any other known contraindications to risperidone as stated in the SmPC&#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>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>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 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>Risperidone</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/NCT01708616
org study id: BP28318
secondary id: 2012-003231-31
nct id: NCT01708616
lead sponsor: 
This single-center, randomized, double-blind, two-period crossover study will evaluate the
      safety, tolerability, pharmacokinetics and pharmacodynamic effects of the combination of
      multiple doses of RO5285119 with a single dose of risperidone in healthy volunteers. Subjects
      will be randomized to one of 4 treatment sequences of two periods to receive multiple doses
      of RO5285119 plus a single dose of risperidone or risperidone placebo or multiple doses of
      RO5285119 placebo plus a single dose of risperidone or risperidone placebo, with a washout
      period of approximately 3 weeks between treatment periods. Anticipated time on study is up to
      12 weeks (from screening through study completion).
intervention model: Crossover Assignment
masking: Double (Participant, Investigator)
measure: Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Maximum plasma concentration (Cmax)
time frame: Pre-dose to 24 hours post-dose
measure: Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Area under the concentration-time curve (AUC)
time frame: Pre-dose to 24 hours post-dose
measure: Safety: Incidence of adverse events
time frame: approximately 12 weeks
measure: Pharmacodynamic markers for risperidone: Prolactin levels
time frame: Pre-dose to 6 hours post-dose
measure: Pharmacodynamic assessments for risperidone: Level of sedation
time frame: Pre-dose to 24 hours post-dose
measure: Pharmacokinetics of RO5285119 in combination with single dose risperidone: Maximum plasma concentration (Cmax)
time frame: Day 1 to Day 18
measure: Pharmacokinetics of RO5285119 in combination with single dose risperidone: Area under the concentration-time curve (AUC)
time frame: Day1 to Day 18
arm group label: Placebo + risperidone
arm group type: Placebo Comparator
arm group label: Placebo +placebo
arm group type: Placebo Comparator
arm group label: RO5285119 + placebo
arm group type: Active Comparator
arm group label: RO5285119 + risperidone
arm group type: Experimental
intervention type: Drug
intervention name: RO5285119
description: multiple doses
arm group label: RO5285119 + placebo
arm group label: RO5285119 + risperidone
intervention type: Drug
intervention name: RO5285119 placebo
description: multiple doses
arm group label: Placebo + risperidone
arm group label: Placebo +placebo
intervention type: Drug
intervention name: risperidone
description: single dose
arm group label: Placebo + risperidone
arm group label: RO5285119 + risperidone
intervention type: Drug
intervention name: risperidone placebo
description: single dose
arm group label: Placebo +placebo
arm group label: RO5285119 + placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 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: Risperidone