<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/NCT02196636</url>
  </required_header>
  <id_info>
    <org_study_id>BP29276</org_study_id>
    <secondary_id>2014-001019-38</secondary_id>
    <nct_id>NCT02196636</nct_id>
  </id_info>
  <brief_title>A Phase 1 Study of RO6806127 in Healthy Male Volunteers</brief_title>
  <official_title>A Single-center, Randomised, Double-blind, Adaptative, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including the Effect of Food), and Pharmacodynamics or RO6806127 in Healthy Male 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 two-part study will assess the safety and tolerability of single ascending oral doses of&#xD;
      RO6806127 in a group of healthy male participants and investigate the effect of high fat and&#xD;
      high caloric food on the relative bioavailability of a single oral dose of RO6806127 in a&#xD;
      separate group of healthy male participants. The relationship between drug exposure and&#xD;
      tolerability will be explored.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>Incidence of adverse events</measure>
    <time_frame>Up to Day 21</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Phamacokinetic profile of single-dose oral RO6806127 and its metabolites as appropriate, as assessed by concentrations over time in plasma and urine</measure>
    <time_frame>Up to Day 21</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RO6806127 metabolite concentrations in selected plasma and urine samples</measure>
    <time_frame>Up to Day 21</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative bioavailability (food effect): Area under the concentration-time curves [AUC]</measure>
    <time_frame>Up to Day 21</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Healthy Volunteer</condition>
  <arm_group>
    <arm_group_label>Part 1: Single Ascending Dose (SAD)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adaptive model per protocol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Food Effect (FE)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fasted versus Fed</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo, administered orally with approximately 240 mL of buffer</description>
    <arm_group_label>Part 1: Single Ascending Dose (SAD)</arm_group_label>
    <arm_group_label>Part 2: Food Effect (FE)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RO6806127</intervention_name>
    <description>Administered orally with approximately 240 mL of buffer</description>
    <arm_group_label>Part 1: Single Ascending Dose (SAD)</arm_group_label>
    <arm_group_label>Part 2: Food Effect (FE)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male participants aged 18 to 45 years, inclusive&#xD;
&#xD;
          -  A BMI between 18 to 30 kg/m2, inclusive&#xD;
&#xD;
          -  Agreement to use highly effective contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically significant abnormalities in laboratory test results&#xD;
&#xD;
          -  History of any clinically significant gastrointestinal, renal, hepatic,&#xD;
             broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological,&#xD;
             hematological or allergic disease, metabolic disorder, cancer or cirrhosis&#xD;
&#xD;
          -  Significant disorders of the central nervous system, including psychiatric disorders,&#xD;
             behavioral disturbances, cerebrovascular events, depression, bipolar disorder,&#xD;
             migraine, Parkinson, anxiety, any personal or familial history of seizures, epilepsy&#xD;
             or other convulsive condition, previous significant head trauma, or other factors&#xD;
             predisposing to seizures&#xD;
&#xD;
          -  Use of any prohibited medications and food before study start and during the study&#xD;
&#xD;
          -  Dietary restrictions that would prohibit the consumption of standardized meals&#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>Marlton</city>
        <state>New Jersey</state>
        <zip>08053</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Netherlands</country>
  </removed_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</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/NCT02196636
org study id: BP29276
secondary id: 2014-001019-38
nct id: NCT02196636
lead sponsor: 
This two-part study will assess the safety and tolerability of single ascending oral doses of
      RO6806127 in a group of healthy male participants and investigate the effect of high fat and
      high caloric food on the relative bioavailability of a single oral dose of RO6806127 in a
      separate group of healthy male participants. The relationship between drug exposure and
      tolerability will be explored.
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Investigator)
measure: Incidence of adverse events
time frame: Up to Day 21
measure: Phamacokinetic profile of single-dose oral RO6806127 and its metabolites as appropriate, as assessed by concentrations over time in plasma and urine
time frame: Up to Day 21
measure: RO6806127 metabolite concentrations in selected plasma and urine samples
time frame: Up to Day 21
measure: Relative bioavailability (food effect): Area under the concentration-time curves [AUC]
time frame: Up to Day 21
arm group label: Part 1: Single Ascending Dose (SAD)
arm group type: Experimental
description: Adaptive model per protocol
arm group label: Part 2: Food Effect (FE)
arm group type: Experimental
description: Fasted versus Fed
intervention type: Drug
intervention name: Placebo
description: Matching placebo, administered orally with approximately 240 mL of buffer
arm group label: Part 1: Single Ascending Dose (SAD)
arm group label: Part 2: Food Effect (FE)
intervention type: Drug
intervention name: RO6806127
description: Administered orally with approximately 240 mL of buffer
arm group label: Part 1: Single Ascending Dose (SAD)
arm group label: Part 2: Food Effect (FE)
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: United States
country: Netherlands
responsible party type: Sponsor