<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/NCT01684891</url>
  </required_header>
  <id_info>
    <org_study_id>WP28214</org_study_id>
    <secondary_id>2012-001434-34</secondary_id>
    <nct_id>NCT01684891</nct_id>
  </id_info>
  <brief_title>A 28-Day Pharmacokinetics Study of RG1662 in Healthy Male Volunteers</brief_title>
  <official_title>Single-center, Open Label, Multiple Dose Study to Investigate the Pharmacokinetics of RG1662 Given BID Over 28 Days, and in Addition, the Excretion and Metabolism of [13C]-Labelled IV Microdoses and an Oral [14C]-Labelled Dose of RG1662 in Healthy Male 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 is a single-center, open label, multiple dose study to investigate the pharmacokinetics&#xD;
      of RG1662 given twice daily over 28 days, and in addition, the excretion and metabolism of&#xD;
      [13C]-labeled IV microdoses and an oral [14C]-labeled dose of RG1662 in healthy male&#xD;
      volunteers. The anticipated time of study treatment is 4 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</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>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics: Area under the concentration time curve (AUC)</measure>
    <time_frame>Selected Days between 1 and 28</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: maximum serum concentration</measure>
    <time_frame>Selected Days between 1 and 28</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: Clearance of 13C-RG1662</measure>
    <time_frame>Days 1 and 28</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: Bioavailability of 13C-RG1662</measure>
    <time_frame>Days 1 and 28</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Amount of drug excreted in urine over the sampling interval</measure>
    <time_frame>Days 1 to 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of drug excreted in the feces over the sampling interval</measure>
    <time_frame>Pre-dose, days 1 to 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Up to approximately 10 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Healthy Volunteer</condition>
  <arm_group>
    <arm_group_label>RG1662</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RG1662</intervention_name>
    <description>multiple doses of RG1662</description>
    <arm_group_label>RG1662</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male volunteers&#xD;
&#xD;
          -  Volunteers who are surgically sterilized or who do not intend to father children in&#xD;
             the future&#xD;
&#xD;
          -  Absence of evidence of any active or chronic disease following a detailed medical and&#xD;
             surgical history, a complete physical examination including vital signs, 12-lead ECG,&#xD;
             hematology, blood chemistry, serology and urinalysis&#xD;
&#xD;
          -  Body mass index (BMI) between 18 and 30 kg/m2 inclusive&#xD;
&#xD;
          -  Volunteers and their partners of childbearing potential must use two medically&#xD;
             approved methods of contraception (e.g. hormonal contraception, IUD, barrier&#xD;
             contraception), one of which must be a barrier method, for the duration of the study&#xD;
             and for 3 months after last drug administration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If capable of reproduction, unwilling to use an effective form of contraception&#xD;
&#xD;
          -  Suspicion of regular consumption of drug of abuse&#xD;
&#xD;
          -  Positive result on hepatitis B (HBV), hepatitis C (HCV), or HIV 1 and 2&#xD;
&#xD;
          -  Clinically relevant ECG abnormalities at screening&#xD;
&#xD;
          -  Family history of congenital long QT syndrome or known congenital arrhythmia&#xD;
&#xD;
          -  Systolic blood pressure greater than 140 or less than 90 mm Hg, and diastolic blood&#xD;
             pressure greater than 90 or less than 50 mm Hg. Resting Pulse Rate greater than 90 or&#xD;
             less than 45 beats per minute&#xD;
&#xD;
          -  Any other clinical relevant clinical abnormalities&#xD;
&#xD;
          -  Participation in an investigational drug or device study within 90 days prior to&#xD;
             screening&#xD;
&#xD;
          -  Donation of more than 500 mL of blood within three months prior to screening&#xD;
&#xD;
          -  Concomitant disease or condition that could interfere with, or treatment of which&#xD;
             might interfere with, the conduct of the study, or that would, in the opinion of the&#xD;
             investigator, pose an unacceptable risk to the volunteer in this study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>55 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>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 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/NCT01684891
org study id: WP28214
secondary id: 2012-001434-34
nct id: NCT01684891
lead sponsor: 
This is a single-center, open label, multiple dose study to investigate the pharmacokinetics
      of RG1662 given twice daily over 28 days, and in addition, the excretion and metabolism of
      [13C]-labeled IV microdoses and an oral [14C]-labeled dose of RG1662 in healthy male
      volunteers. The anticipated time of study treatment is 4 weeks.
allocation: Non-Randomized
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Pharmacokinetics: Area under the concentration time curve (AUC)
time frame: Selected Days between 1 and 28
measure: Pharmacokinetics: maximum serum concentration
time frame: Selected Days between 1 and 28
measure: Pharmacokinetics: Clearance of 13C-RG1662
time frame: Days 1 and 28
measure: Pharmacokinetics: Bioavailability of 13C-RG1662
time frame: Days 1 and 28
measure: Amount of drug excreted in urine over the sampling interval
time frame: Days 1 to 15
measure: Amount of drug excreted in the feces over the sampling interval
time frame: Pre-dose, days 1 to 15
measure: Incidence of adverse events
time frame: Up to approximately 10 weeks
arm group label: RG1662
arm group type: Experimental
intervention type: Drug
intervention name: RG1662
description: multiple doses of RG1662
arm group label: RG1662
criteria: 
gender: Male
minimum age: 30 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
country: Netherlands
responsible party type: Sponsor