<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/NCT02254759</url>
  </required_header>
  <id_info>
    <org_study_id>WP29393</org_study_id>
    <secondary_id>2014-001850-41</secondary_id>
    <nct_id>NCT02254759</nct_id>
  </id_info>
  <brief_title>A Study of RO5186582 Treatment on Cytochrome P450 (CYP) 3A4 Activity in Healthy Participants</brief_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 is a non-randomized, open-label, five treatment, fixed sequence cross-over study to&#xD;
      investigate the effect of RO5186582 treatment on CYP3A activity using midazolam as a probe&#xD;
      CYP3A substrate, and also to assess the pharmacodynamic measures of brain electrical activity&#xD;
      and sedation to explore the pharmacodynamic interaction between the gama-amino butyric acid&#xD;
      (GABA)A negative allosteric modulator RO5186582 and the prototypical GABAA positive&#xD;
      allosteric modulator midazolam. The anticipated study duration is up to nine weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bioavailability of Drug (F) for Oral Midazolam</measure>
    <time_frame>Pre-dose [-0.5 hour (h)] and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 14 h post-dose (pd) on Day (D) 2 and 18, and 22 h pd on D3 and 19</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Plasma Clearence (CL) for IV Midazolam</measure>
    <time_frame>Pre-dose [-10 minutes (min)] and 0.08 (5 min), 0.25 (15 min), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 14 h pd on D1 and D17, and 22 h pd on D2 and D18</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Volume of Distribution at Steady-State (Vss) for IV Midazolam</measure>
    <time_frame>Pre-dose (-10 min) and 0.08 (5 min), 0.25 (15 min), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 14 h pd on D1 and D17, and 22 h pd on D2 and D18</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) for Oral Midazolam</measure>
    <time_frame>Pre-dose (-0.5 h) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 14 h pd on D2 and 18, and 22 h pd on D3 and D19</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Apparent Volume of Distribution (V/F) for Oral Midazolam</measure>
    <time_frame>Pre-dose (-0.5 h) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 14 h pd on D2 and D18, and 22 h pd on D3 and D19</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration Time Curve from Time Zero to Time Tau, Where Tau is the Dosing Interval (AUC0-tau) for RO5186582 and RO5271857 (metabolite of RO5186582)</measure>
    <time_frame>D18: Pre-dose -0.17 h (10 min) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 h pd</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax for RO5186582 and RO5271857 (metabolite of RO5186582)</measure>
    <time_frame>Pre-dose (10 min) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 h pd on D18 (timepoints relative to oral midazolam dosing are (- 2 h 10 min), -1.5, -1, -0.5, 0 h pre-dose and 1, 2, 3, 4, 6, 8, and 10 h pd)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax for RO5186582 and RO5271857 (metabolite of RO5186582)</measure>
    <time_frame>Pre-dose (10 min) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 h pd on D18 (timepoints relative to oral midazolam dosing are (- 2 h 10 min), -1.5, -1, -0.5, 0 h pre-dose and 1, 2, 3, 4, 6, 8, and 10 h pd)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic Ratio Based on AUC0-inf for IV Midazolam</measure>
    <time_frame>Pre-dose (-10 min) and 0.08 (5 min), 0.25 (15 min), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 14 h pd on D1 and D17, and 22 h pd on D2 and D18</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Event-Related Potential (ERP) parameters Using Oddball Auditory</measure>
    <time_frame>D-1 (Baseline) and D16 at 1 and 4 h pd, time-matched to planned time, and D2 and D8 at 1 and 4 h pd</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Electroencephalogram (EEG) Parameters</measure>
    <time_frame>D-1 (Baseline) and D16 at 1 and 4 h pd, time-matched to planned time, and D2 and D8 at 1 and 4 h pd</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Saccadic Eye Movement (SEM) Parameters</measure>
    <time_frame>D-1 (Baseline) and D16 at 1 h pd, time-matched to planned time, and D2 and D18 at 1 h pd</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Attention and Memory of Selected Domains of Repeatable Battery for the Assessment of Neuropyschological Status (RBANSTM)</measure>
    <time_frame>D-1 (Baseline) and D16 at 2 and 5 h pd, time-matched to planned time, and D2 and D18 at 2 and 5 h pd</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Concentration of 4 Beta-Hydroxy Cholesterol</measure>
    <time_frame>D1 (Baseline) and D17</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration Time Curve from Zero to Infinity (AUC0-inf) for Oral and IV Midazolam</measure>
    <time_frame>Midazolam (MDZ)-oral: pre-dose (-0.5 h) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 14 h pd on D2 and 18, and 22 h pd on D3 and 19; MDZ-IV: Pre-dose (-10 min) and 5, 15 min, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 14 h pd on D1 and 17, and 22 h pd on D2 and 18</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax for IV Midazolam</measure>
    <time_frame>Pre-dose (-10 min) and 5, 15 min, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 14 h pd on D1 and 17, and 22 h pd on D2 and 18</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration Time Curve from Zero to Last Measurable Concentration (AUC[0-last]) for Oral and IV Midazolam</measure>
    <time_frame>MDZ-oral: pre-dose (-0.5 h) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 14 h pd on D2 and 18, and 22 h pd on D3 and 19; MDZ-IV: Pre-dose (-10 min) and 5, 15 min, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 14 h pd on D1 and 17, and 22 h pd on D2 and 18</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Maximum Observed Concentration (Tmax) for Oral and IV Midazolam</measure>
    <time_frame>MDZ-oral: pre-dose (-0.5 h) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 14 h pd on D2 and 18, and 22 h pd on D3 and 19; MDZ-IV: Pre-dose (-10 min) and 5, 15 min, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 14 h pd on D1 and 17, and 22 h pd on D2 and 18</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal Elimination Half-Life (t1/2) for Oral and IV Midazolam</measure>
    <time_frame>MDZ-oral: pre-dose (-0.5 h) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 14 h pd on D2 and 18, and 22 h pd on D3 and 19; MDZ-IV: Pre-dose (-10 min) and 5, 15 min, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 14 h pd on D1 and 17, and 22 h pd on D2 and 18</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Clearence (CL/F) for Oral Midazolam</measure>
    <time_frame>Pre-dose (-0.5 h) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 14 h pd on D2 and D18, and 22 h pd on D3 and D19</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy Volunteer</condition>
  <arm_group>
    <arm_group_label>IV Midazolam Alone</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A single 1 milligram (mg) dose of IV Midazolam on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral Midazolam Alone</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A single 5 mg oral dose of midazolam on Day 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RO5186582 Alone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RO5186582 240 mg oral tablet twice daily (BID) for 14 days from Days 3 to 16.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RO5186582 Plus IV Midazolam</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RO5186582 240 mg BID oral tablet in combination with a single 1 mg IV dose of midazolam on Day 17.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RO5186582 Plus Oral Midazolam</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RO5186582 240 mg BID in combination with a single 5 mg oral dose of midazolam on Day 18.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam, IV</intervention_name>
    <description>2 milligrams per milliliter (mg/mL) midazolam solution for IV administration. For a 1 mg dose, the midazolam solution (0.5 mL of 2 mg/mL) will be injected at 2 milligrams per minute (mg/min).</description>
    <arm_group_label>IV Midazolam Alone</arm_group_label>
    <arm_group_label>RO5186582 Plus IV Midazolam</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam, oral</intervention_name>
    <description>0.1 mg/mL midazolam for oral administration. For a 5 mg dose, participants will receive 50 mL of 0.1 mg/mL midazolam.</description>
    <arm_group_label>Oral Midazolam Alone</arm_group_label>
    <arm_group_label>RO5186582 Plus Oral Midazolam</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RO5186582</intervention_name>
    <description>RO5186582 120 mg film-coated release tablet.</description>
    <arm_group_label>RO5186582 Alone</arm_group_label>
    <arm_group_label>RO5186582 Plus IV Midazolam</arm_group_label>
    <arm_group_label>RO5186582 Plus Oral Midazolam</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy participants with signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A history of epilepsy, convulsions or significant head injury&#xD;
&#xD;
          -  Significant history of drug allergy, as determined by the Investigator, or a known&#xD;
             hypersensitivity to any of the ingredients of any of the study treatments&#xD;
&#xD;
          -  Use of any drugs or substances, including herbal treatments such as St John's Wort,&#xD;
             that are known to be substrates, inducers or inhibitors of CYP3A4 within 30 days of&#xD;
             the first dose administration&#xD;
&#xD;
          -  Pregnant or lactating&#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>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Midazolam</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02254759
org study id: WP29393
secondary id: 2014-001850-41
nct id: NCT02254759
lead sponsor: 
This is a non-randomized, open-label, five treatment, fixed sequence cross-over study to
      investigate the effect of RO5186582 treatment on CYP3A activity using midazolam as a probe
      CYP3A substrate, and also to assess the pharmacodynamic measures of brain electrical activity
      and sedation to explore the pharmacodynamic interaction between the gama-amino butyric acid
      (GABA)A negative allosteric modulator RO5186582 and the prototypical GABAA positive
      allosteric modulator midazolam. The anticipated study duration is up to nine weeks.
allocation: Non-Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: Bioavailability of Drug (F) for Oral Midazolam
time frame: Pre-dose [-0.5 hour (h)] and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 14 h post-dose (pd) on Day (D) 2 and 18, and 22 h pd on D3 and 19
measure: Total Plasma Clearence (CL) for IV Midazolam
time frame: Pre-dose [-10 minutes (min)] and 0.08 (5 min), 0.25 (15 min), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 14 h pd on D1 and D17, and 22 h pd on D2 and D18
measure: Apparent Volume of Distribution at Steady-State (Vss) for IV Midazolam
time frame: Pre-dose (-10 min) and 0.08 (5 min), 0.25 (15 min), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 14 h pd on D1 and D17, and 22 h pd on D2 and D18
measure: Maximum Observed Plasma Concentration (Cmax) for Oral Midazolam
time frame: Pre-dose (-0.5 h) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 14 h pd on D2 and 18, and 22 h pd on D3 and D19
measure: Apparent Volume of Distribution (V/F) for Oral Midazolam
time frame: Pre-dose (-0.5 h) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 14 h pd on D2 and D18, and 22 h pd on D3 and D19
measure: Area Under the Plasma Concentration Time Curve from Time Zero to Time Tau, Where Tau is the Dosing Interval (AUC0-tau) for RO5186582 and RO5271857 (metabolite of RO5186582)
time frame: D18: Pre-dose -0.17 h (10 min) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 h pd
measure: Cmax for RO5186582 and RO5271857 (metabolite of RO5186582)
time frame: Pre-dose (10 min) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 h pd on D18 (timepoints relative to oral midazolam dosing are (- 2 h 10 min), -1.5, -1, -0.5, 0 h pre-dose and 1, 2, 3, 4, 6, 8, and 10 h pd)
measure: Tmax for RO5186582 and RO5271857 (metabolite of RO5186582)
time frame: Pre-dose (10 min) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 h pd on D18 (timepoints relative to oral midazolam dosing are (- 2 h 10 min), -1.5, -1, -0.5, 0 h pre-dose and 1, 2, 3, 4, 6, 8, and 10 h pd)
measure: Metabolic Ratio Based on AUC0-inf for IV Midazolam
time frame: Pre-dose (-10 min) and 0.08 (5 min), 0.25 (15 min), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 14 h pd on D1 and D17, and 22 h pd on D2 and D18
measure: Change From Baseline in Event-Related Potential (ERP) parameters Using Oddball Auditory
time frame: D-1 (Baseline) and D16 at 1 and 4 h pd, time-matched to planned time, and D2 and D8 at 1 and 4 h pd
measure: Change from Baseline in Electroencephalogram (EEG) Parameters
time frame: D-1 (Baseline) and D16 at 1 and 4 h pd, time-matched to planned time, and D2 and D8 at 1 and 4 h pd
measure: Change From Baseline in Saccadic Eye Movement (SEM) Parameters
time frame: D-1 (Baseline) and D16 at 1 h pd, time-matched to planned time, and D2 and D18 at 1 h pd
measure: Change From Baseline in Attention and Memory of Selected Domains of Repeatable Battery for the Assessment of Neuropyschological Status (RBANSTM)
time frame: D-1 (Baseline) and D16 at 2 and 5 h pd, time-matched to planned time, and D2 and D18 at 2 and 5 h pd
measure: Change from Baseline in Concentration of 4 Beta-Hydroxy Cholesterol
time frame: D1 (Baseline) and D17
measure: Area Under the Plasma Concentration Time Curve from Zero to Infinity (AUC0-inf) for Oral and IV Midazolam
time frame: Midazolam (MDZ)-oral: pre-dose (-0.5 h) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 14 h pd on D2 and 18, and 22 h pd on D3 and 19; MDZ-IV: Pre-dose (-10 min) and 5, 15 min, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 14 h pd on D1 and 17, and 22 h pd on D2 and 18
measure: Cmax for IV Midazolam
time frame: Pre-dose (-10 min) and 5, 15 min, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 14 h pd on D1 and 17, and 22 h pd on D2 and 18
measure: Area Under the Plasma Concentration Time Curve from Zero to Last Measurable Concentration (AUC[0-last]) for Oral and IV Midazolam
time frame: MDZ-oral: pre-dose (-0.5 h) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 14 h pd on D2 and 18, and 22 h pd on D3 and 19; MDZ-IV: Pre-dose (-10 min) and 5, 15 min, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 14 h pd on D1 and 17, and 22 h pd on D2 and 18
measure: Time to Maximum Observed Concentration (Tmax) for Oral and IV Midazolam
time frame: MDZ-oral: pre-dose (-0.5 h) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 14 h pd on D2 and 18, and 22 h pd on D3 and 19; MDZ-IV: Pre-dose (-10 min) and 5, 15 min, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 14 h pd on D1 and 17, and 22 h pd on D2 and 18
measure: Terminal Elimination Half-Life (t1/2) for Oral and IV Midazolam
time frame: MDZ-oral: pre-dose (-0.5 h) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 14 h pd on D2 and 18, and 22 h pd on D3 and 19; MDZ-IV: Pre-dose (-10 min) and 5, 15 min, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 14 h pd on D1 and 17, and 22 h pd on D2 and 18
measure: Apparent Clearence (CL/F) for Oral Midazolam
time frame: Pre-dose (-0.5 h) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 14 h pd on D2 and D18, and 22 h pd on D3 and D19
arm group label: IV Midazolam Alone
arm group type: Other
description: A single 1 milligram (mg) dose of IV Midazolam on Day 1.
arm group label: Oral Midazolam Alone
arm group type: Other
description: A single 5 mg oral dose of midazolam on Day 2.
arm group label: RO5186582 Alone
arm group type: Experimental
description: RO5186582 240 mg oral tablet twice daily (BID) for 14 days from Days 3 to 16.
arm group label: RO5186582 Plus IV Midazolam
arm group type: Experimental
description: RO5186582 240 mg BID oral tablet in combination with a single 1 mg IV dose of midazolam on Day 17.
arm group label: RO5186582 Plus Oral Midazolam
arm group type: Experimental
description: RO5186582 240 mg BID in combination with a single 5 mg oral dose of midazolam on Day 18.
intervention type: Drug
intervention name: Midazolam, IV
description: 2 milligrams per milliliter (mg/mL) midazolam solution for IV administration. For a 1 mg dose, the midazolam solution (0.5 mL of 2 mg/mL) will be injected at 2 milligrams per minute (mg/min).
arm group label: IV Midazolam Alone
arm group label: RO5186582 Plus IV Midazolam
intervention type: Drug
intervention name: Midazolam, oral
description: 0.1 mg/mL midazolam for oral administration. For a 5 mg dose, participants will receive 50 mL of 0.1 mg/mL midazolam.
arm group label: Oral Midazolam Alone
arm group label: RO5186582 Plus Oral Midazolam
intervention type: Drug
intervention name: RO5186582
description: RO5186582 120 mg film-coated release tablet.
arm group label: RO5186582 Alone
arm group label: RO5186582 Plus IV Midazolam
arm group label: RO5186582 Plus Oral Midazolam
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
mesh term: Midazolam