<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/NCT01711801</url>
  </required_header>
  <id_info>
    <org_study_id>BP28373</org_study_id>
    <secondary_id>2012-002869-35</secondary_id>
    <nct_id>NCT01711801</nct_id>
  </id_info>
  <brief_title>A Study of Safety, Pharmacokinetics (Including Food Effect) And Pharmacodynamics of RO5545965 in Healthy Volunteers</brief_title>
  <official_title>A Single-Center, Randomized, Investigator/Subject-Blind, Adaptive Single-Ascending Dose, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including the Effect of Food), and Pharmacodynamics of RO5545965 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 randomized, Investigator/Subject-blind, adaptive single-ascending-dose,&#xD;
      placebo-controlled, parallel study will evaluate the safety, tolerability, pharmacokinetics&#xD;
      (including the effect of food), and pharmacodynamics of RO5545965 following oral&#xD;
      administration in healthy male volunteers. In Part 1, subjects will be randomized in cohorts&#xD;
      to receive single ascending doses of RO5545965 or placebo. In Part 2, subjects will receive 2&#xD;
      doses of RO5545965, in the fed or fasted state, in randomized sequence with a washout period&#xD;
      of approximately 2 weeks between treatment periods.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</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>up to approximately 10 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Area under the concentration-time curve (AUC)</measure>
    <time_frame>Pre-dose and up to 48 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Maximum plasma concentration (Cmax)</measure>
    <time_frame>Pre-dose and up to 48 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics: Prolactin levels</measure>
    <time_frame>Pre-dose and up to 10 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of food on the pharmacokinetics of single dose RO55459965: Area under the concentration-time curve (AUC)</measure>
    <time_frame>pre-dose and up to 48 hours post-dose</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Healthy Volunteer</condition>
  <arm_group>
    <arm_group_label>Part 1: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1: RO5545965</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Food effect</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Single ascending dose</description>
    <arm_group_label>Part 1: Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RO5545965</intervention_name>
    <description>Single ascending dose</description>
    <arm_group_label>Part 1: RO5545965</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RO5545965</intervention_name>
    <description>Single dose, in fed and fasted state</description>
    <arm_group_label>Part 2: Food effect</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male volunteers, 18 to 45 years of age, inclusive. Healthy status is defined&#xD;
             by absence of evidence of any active or chronic disease following a detailed medical&#xD;
             and surgical history, a complete 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;
          -  Male subjects (whether surgically sterilized or not) with female partners of&#xD;
             child-bearing potential must use two forms of contraception, one of which must be a&#xD;
             barrier method, for the duration of the study and for 77 days after the last dose&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or presence of any clinically significant disease or disorder&#xD;
&#xD;
          -  Any condition or disease that would render the subject unsuitable for the study, place&#xD;
             the subject at undue risk or interfere with the ability of the subject to complete the&#xD;
             study in the opinion of the investigator&#xD;
&#xD;
          -  History of clinically significant hypersensitivity or allergic drug reactions&#xD;
&#xD;
          -  Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse&#xD;
&#xD;
          -  Regular smoker (&gt; 5 cigarettes, &gt; 1 pipeful or &gt; 1 cigar per day)&#xD;
&#xD;
          -  Positive for hepatitis B, hepatitis C or HIV infection&#xD;
&#xD;
          -  Dietary restrictions that would prohibit the consumption of standardized meals&#xD;
&#xD;
          -  Participation in an investigational drug or device study within 90 days prior to&#xD;
             screening, as calculated from the follow-up from the previous study&#xD;
      </textblock>
    </criteria>
    <gender>Male</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>Zuidlaren</city>
        <zip>9471 GP</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</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/NCT01711801
org study id: BP28373
secondary id: 2012-002869-35
nct id: NCT01711801
lead sponsor: 
This randomized, Investigator/Subject-blind, adaptive single-ascending-dose,
      placebo-controlled, parallel study will evaluate the safety, tolerability, pharmacokinetics
      (including the effect of food), and pharmacodynamics of RO5545965 following oral
      administration in healthy male volunteers. In Part 1, subjects will be randomized in cohorts
      to receive single ascending doses of RO5545965 or placebo. In Part 2, subjects will receive 2
      doses of RO5545965, in the fed or fasted state, in randomized sequence with a washout period
      of approximately 2 weeks between treatment periods.
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Investigator)
measure: Safety: Incidence of adverse events
time frame: up to approximately 10 weeks
measure: Pharmacokinetics: Area under the concentration-time curve (AUC)
time frame: Pre-dose and up to 48 hours post-dose
measure: Pharmacokinetics: Maximum plasma concentration (Cmax)
time frame: Pre-dose and up to 48 hours post-dose
measure: Pharmacodynamics: Prolactin levels
time frame: Pre-dose and up to 10 hours post-dose
measure: Effect of food on the pharmacokinetics of single dose RO55459965: Area under the concentration-time curve (AUC)
time frame: pre-dose and up to 48 hours post-dose
arm group label: Part 1: Placebo
arm group type: Placebo Comparator
arm group label: Part 1: RO5545965
arm group type: Experimental
arm group label: Part 2: Food effect
arm group type: Experimental
intervention type: Drug
intervention name: Placebo
description: Single ascending dose
arm group label: Part 1: Placebo
intervention type: Drug
intervention name: RO5545965
description: Single ascending dose
arm group label: Part 1: RO5545965
intervention type: Drug
intervention name: RO5545965
description: Single dose, in fed and fasted state
arm group label: Part 2: Food effect
criteria: 
gender: Male
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: Netherlands
responsible party type: Sponsor