<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT01665976</url>
  </required_header>
  <id_info>
    <org_study_id>BP25593</org_study_id>
    <secondary_id>2012-000739-13</secondary_id>
    <nct_id>NCT01665976</nct_id>
  </id_info>
  <brief_title>A Study of the Relative Bioavailability of Single Dose RO4917838 and the Effect of Food in Healthy Volunteers</brief_title>
  <official_title>A Single Center, Randomized, Single Dose, Open-label, Four Period Cross-over Study to Investigate the Relative Bioavailability of RO4917838 and the Effect of Food 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, single dose, open-label, four period cross-over study will&#xD;
      evaluate the relative bioavailability of RO4917838 and the effect of food following oral&#xD;
      administration in healthy volunteers. Subjects will receive in randomized order single oral&#xD;
      doses of RO4917838 film coated tablets, either in the fasted or fed condition, or RO4917838&#xD;
      hard gelatin capsules or RO4917838 oral suspension, with a washout period of at least 21 days&#xD;
      between treatments. Anticipated time on study will be up to 23 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 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>Crossover Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of high fat and high caloric food on the relative bioavailability of single dose RO4917838 film coated tablets (FCT): Area under the concentration-time curve (AUC)</measure>
    <time_frame>Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Relative bioavailability of single dose RO4917838 hard gelatin capsules as compared to FCT: Area under the concentration-time curve</measure>
    <time_frame>Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Relative bioavailability of single dose RO4917838 oral suspension as compared to FCT</measure>
    <time_frame>Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety: Incidence of adverse events</measure>
    <time_frame>approximately 2 months</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Healthy Volunteer</condition>
  <arm_group>
    <arm_group_label>A: film coated tablets, fasted condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>B: film coated tablets, fed condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>C: hard gelatin capsules</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>D: oral suspension</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RO4917838</intervention_name>
    <description>film coated tablet, single dose</description>
    <arm_group_label>A: film coated tablets, fasted condition</arm_group_label>
    <arm_group_label>B: film coated tablets, fed condition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RO4917838</intervention_name>
    <description>oral suspension, single dose</description>
    <arm_group_label>D: oral suspension</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RO4927838</intervention_name>
    <description>hard gelatin capsule, single dose</description>
    <arm_group_label>C: hard gelatin capsules</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and female volunteers, 18 to 65 years of age, inclusive&#xD;
&#xD;
          -  Body mass index (BMI) 18 to 30 kg/m2 inclusive&#xD;
&#xD;
          -  Healthy as determined by the Investigator on the basis of medical and surgical history&#xD;
             and a complete physical examination&#xD;
&#xD;
          -  Non-smoker or smoker of fewer than 10 cigarettes per day; subject must be able to&#xD;
             refrain from smoking during the in-patient stays&#xD;
&#xD;
          -  Females who are not postmenopausal or surgically sterile must agree to use two&#xD;
             adequate methods of contraception as defined by protocol during the treatment period&#xD;
             and for at least one month after the last dose of study drug&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any condition or disease detected during the medical interview/physical examination&#xD;
             that would render the subject unsuitable for the study, place the subject at undue&#xD;
             risk or interfere with the ability of the subject to complete the study in the opinion&#xD;
             of the Investigator&#xD;
&#xD;
          -  History of alcoholism, drug abuse and/or drug addiction within the last year prior to&#xD;
             Period 1. Day -1 of the study&#xD;
&#xD;
          -  History of any significant cardiovascular, hepatic, renal, respiratory,&#xD;
             gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic,&#xD;
             neurologic, psychiatric disease, or cancer&#xD;
&#xD;
          -  Any history of depressive episodes or treatment with antidepressants&#xD;
&#xD;
          -  Any significant allergic reactions against any drug, or multiple allergies in the&#xD;
             judgement of the Investigator&#xD;
&#xD;
          -  Pregnant or lactating females&#xD;
&#xD;
          -  Positive for hepatitis B, hepatitis C or HIV infection&#xD;
&#xD;
          -  Participation in another investigational study of any type within 90 days of RO4917838&#xD;
             administration or within 6 times the elimination half-life of the tested drug,&#xD;
             whichever is longer&#xD;
      </textblock>
    </criteria>
    <gender>Female</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>Rueil-Malmaison</city>
        <zip>92502</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 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/NCT01665976
org study id: BP25593
secondary id: 2012-000739-13
nct id: NCT01665976
lead sponsor: 
This single center, randomized, single dose, open-label, four period cross-over study will
      evaluate the relative bioavailability of RO4917838 and the effect of food following oral
      administration in healthy volunteers. Subjects will receive in randomized order single oral
      doses of RO4917838 film coated tablets, either in the fasted or fed condition, or RO4917838
      hard gelatin capsules or RO4917838 oral suspension, with a washout period of at least 21 days
      between treatments. Anticipated time on study will be up to 23 weeks.
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: Effect of high fat and high caloric food on the relative bioavailability of single dose RO4917838 film coated tablets (FCT): Area under the concentration-time curve (AUC)
time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12
measure: Relative bioavailability of single dose RO4917838 hard gelatin capsules as compared to FCT: Area under the concentration-time curve
time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12
measure: Relative bioavailability of single dose RO4917838 oral suspension as compared to FCT
time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12
measure: Safety: Incidence of adverse events
time frame: approximately 2 months
arm group label: A: film coated tablets, fasted condition
arm group type: Experimental
arm group label: B: film coated tablets, fed condition
arm group type: Experimental
arm group label: C: hard gelatin capsules
arm group type: Experimental
arm group label: D: oral suspension
arm group type: Experimental
intervention type: Drug
intervention name: RO4917838
description: film coated tablet, single dose
arm group label: A: film coated tablets, fasted condition
arm group label: B: film coated tablets, fed condition
intervention type: Drug
intervention name: RO4917838
description: oral suspension, single dose
arm group label: D: oral suspension
intervention type: Drug
intervention name: RO4927838
description: hard gelatin capsule, single dose
arm group label: C: hard gelatin capsules
criteria: 
gender: Female
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