<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/NCT01664143</url>
  </required_header>
  <id_info>
    <org_study_id>WP28102</org_study_id>
    <secondary_id>2012-000280-24</secondary_id>
    <nct_id>NCT01664143</nct_id>
  </id_info>
  <brief_title>A Single-Center Study of RO5508887 in Healthy Volunteers</brief_title>
  <official_title>A Single-Center, Randomized, Investigator/Subject-Blind, Multiple Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5508887 Following Oral Administration 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, placebo-controlled study will evaluate the&#xD;
      safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. Volunteers&#xD;
      will receive multiple-ascending doses of RO5508887 or matching placebo. The anticipated time&#xD;
      on study treatment is 14 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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety: incidence of adverse events</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of the age on pharmacokinetics of RO5508887</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of the age on pharmacodynamics of RO5508887</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: plasma levels of RO5508887</measure>
    <time_frame>Predose and up to 144 hours post last dose, and at follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics: Plasma levels of amyloid deposition markers</measure>
    <time_frame>Predose and up to 144 hours post last dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of the age on safety of RO5508887</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Healthy Volunteer</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>RO5508887</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Multiple doses of placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RO5508887</intervention_name>
    <description>Multiple doses of RO5508887</description>
    <arm_group_label>RO5508887</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult healthy volunteers, &gt;/=18 years of age&#xD;
&#xD;
          -  Body mass index (BMI) between 18 and 30 kg/m2 inclusive&#xD;
&#xD;
          -  Use of adequate contraception methods or surgically sterile&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of active or chronic disease&#xD;
&#xD;
          -  Regular consumption of drugs of abuse&#xD;
&#xD;
          -  Regular smoker (&gt;5 cigarettes per day)&#xD;
&#xD;
          -  Infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C&#xD;
             (HCV)&#xD;
&#xD;
          -  History of significant allergic reactions&#xD;
&#xD;
          -  Abnormal blood pressure&#xD;
&#xD;
          -  Clinical significant abnormalities (e.g., cardiovascular, laboratory values)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</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>Strasbourg</city>
        <zip>67064</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 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/NCT01664143
org study id: WP28102
secondary id: 2012-000280-24
nct id: NCT01664143
lead sponsor: 
This single-center, randomized, double-blind, placebo-controlled study will evaluate the
      safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. Volunteers
      will receive multiple-ascending doses of RO5508887 or matching placebo. The anticipated time
      on study treatment is 14 days.
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Investigator)
measure: Safety: incidence of adverse events
time frame: 30 days
measure: Correlation of the age on pharmacokinetics of RO5508887
time frame: 30 days
measure: Correlation of the age on pharmacodynamics of RO5508887
time frame: 30 days
measure: Pharmacokinetics: plasma levels of RO5508887
time frame: Predose and up to 144 hours post last dose, and at follow-up
measure: Pharmacodynamics: Plasma levels of amyloid deposition markers
time frame: Predose and up to 144 hours post last dose
measure: Correlation of the age on safety of RO5508887
time frame: 30 days
arm group label: Placebo
arm group type: Placebo Comparator
arm group label: RO5508887
arm group type: Experimental
intervention type: Drug
intervention name: Placebo
description: Multiple doses of placebo
arm group label: Placebo
intervention type: Drug
intervention name: RO5508887
description: Multiple doses of RO5508887
arm group label: RO5508887
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
country: France
country: United States
responsible party type: Sponsor