<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/NCT02194244</url>
  </required_header>
  <id_info>
    <org_study_id>WP28978</org_study_id>
    <secondary_id>2014-001762-97</secondary_id>
    <nct_id>NCT02194244</nct_id>
  </id_info>
  <brief_title>Comparative Bioavailability Study of Film-coated Tablet and Granule Formulations of RG1662</brief_title>
  <official_title>A Randomized, Open-Label, Four Period, Four-Treatment Crossover Study to Investigate the Comparative Bioavailability of Film-Coated Tablet and Granule Formulations of RG1662 Under Fed and Fasted Conditions in Healthy Volunteers</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 study will compare the pharmacokinetic performance of film-coated tablet and granule&#xD;
      formulations of RG1662 under fed and fasted conditions in healthy volunteers. A randomized,&#xD;
      four-period, four-treatment crossover design is used. In each period, each volunteer will&#xD;
      receive a single oral dose of the tablet or granule formulation either with or without food.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>Granules Fed (test): RG1662 plasma exposure, area under the concentration-time curve</measure>
    <time_frame>Up to 9 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Granules Fasted (test): RG1662 plasma exposure, area under the concentration-time curve</measure>
    <time_frame>Up to 9 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Tablet Fed (reference): RG1662 plasma exposure, area under the concentration-time curve</measure>
    <time_frame>Up to 9 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Tablet Fasted (reference): RG1662 plasma exposure, area under the concentration-time curve</measure>
    <time_frame>Up to 9 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tablet formulation: RG1662 plasma exposure ratio between fed (test) and fasted (reference) conditions, estimated from area under the concentration-time curve measurements</measure>
    <time_frame>Up to 9 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Granule formulation: RG1662 plasma exposure ratio between fed (test) and fasted (reference) conditions, estimated from area under the concentration-time curve measurements</measure>
    <time_frame>Up to 9 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Palatability of the granule formulation, as assessed by questionnaire</measure>
    <time_frame>Day 1, Day 3 in granule administration periods</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: Incidence of adverse events with either formulation</measure>
    <time_frame>Up to 9 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Healthy Volunteer</condition>
  <arm_group>
    <arm_group_label>Granules Fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Granules Fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Tablet Fasted</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Tablet Fed</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RG1662 granules</intervention_name>
    <description>Single dose, oral administration of RG1662 immediate release granules</description>
    <arm_group_label>Granules Fasted</arm_group_label>
    <arm_group_label>Granules Fed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RG1662 tablet</intervention_name>
    <description>Single dose, oral administration of film-coated RG1662 immediate release tablet</description>
    <arm_group_label>Tablet Fasted</arm_group_label>
    <arm_group_label>Tablet Fed</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female volunteers, 18 to 60 years of age, inclusive&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A history of epilepsy, convulsions or significant head injury&#xD;
&#xD;
          -  Any other clinically relevant abnormalities, concomitant diseases or ongoing medical&#xD;
             conditions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 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>Leeds</city>
        <zip>LS2 9LH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 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/NCT02194244
org study id: WP28978
secondary id: 2014-001762-97
nct id: NCT02194244
lead sponsor: 
This study will compare the pharmacokinetic performance of film-coated tablet and granule
      formulations of RG1662 under fed and fasted conditions in healthy volunteers. A randomized,
      four-period, four-treatment crossover design is used. In each period, each volunteer will
      receive a single oral dose of the tablet or granule formulation either with or without food.
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: Granules Fed (test): RG1662 plasma exposure, area under the concentration-time curve
time frame: Up to 9 weeks
measure: Granules Fasted (test): RG1662 plasma exposure, area under the concentration-time curve
time frame: Up to 9 weeks
measure: Tablet Fed (reference): RG1662 plasma exposure, area under the concentration-time curve
time frame: Up to 9 weeks
measure: Tablet Fasted (reference): RG1662 plasma exposure, area under the concentration-time curve
time frame: Up to 9 weeks
measure: Tablet formulation: RG1662 plasma exposure ratio between fed (test) and fasted (reference) conditions, estimated from area under the concentration-time curve measurements
time frame: Up to 9 weeks
measure: Granule formulation: RG1662 plasma exposure ratio between fed (test) and fasted (reference) conditions, estimated from area under the concentration-time curve measurements
time frame: Up to 9 weeks
measure: Palatability of the granule formulation, as assessed by questionnaire
time frame: Day 1, Day 3 in granule administration periods
measure: Safety: Incidence of adverse events with either formulation
time frame: Up to 9 weeks
arm group label: Granules Fasted
arm group type: Experimental
arm group label: Granules Fed
arm group type: Experimental
arm group label: Tablet Fasted
arm group type: Active Comparator
arm group label: Tablet Fed
arm group type: Active Comparator
intervention type: Drug
intervention name: RG1662 granules
description: Single dose, oral administration of RG1662 immediate release granules
arm group label: Granules Fasted
arm group label: Granules Fed
intervention type: Drug
intervention name: RG1662 tablet
description: Single dose, oral administration of film-coated RG1662 immediate release tablet
arm group label: Tablet Fasted
arm group label: Tablet Fed
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
country: United Kingdom
responsible party type: Sponsor