<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/NCT01711762</url>
  </required_header>
  <id_info>
    <org_study_id>GP28369</org_study_id>
    <nct_id>NCT01711762</nct_id>
  </id_info>
  <brief_title>A Pharmacokinetics Study of Radioactive-Labeled GDC-0973 in Healthy Male Volunteers</brief_title>
  <official_title>A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-0973 Following Single Oral Dose Administration in Healthy Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Genentech, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Genentech, Inc.</source>
  <brief_summary>
    <textblock>
      This open-label, non-randomized study will assess the absorption, metabolism, and excretion&#xD;
      of radioactive-labeled [14C]-GDC-0973 in healthy male volunteers. Volunteers will receive a&#xD;
      single dose of [14C]-GDC-0973.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 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>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Route of elimination of [14C]-GDC-0973</measure>
    <time_frame>approximately 8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: maximum observed concentration (Cmax)</measure>
    <time_frame>approximately 8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: time to maximum concentration (tmax)</measure>
    <time_frame>approximately 8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: area under the concentration-time curve</measure>
    <time_frame>approximately 8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: apparent terminal elimination phase rate constant</measure>
    <time_frame>approximately 8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: apparent terminal elimination phase half-life</measure>
    <time_frame>approximately 8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: apparent total clearance</measure>
    <time_frame>approximately 8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: apparent volume of distribution</measure>
    <time_frame>approximately 8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics: amount total radioactivity in whole blood/urine/feces</measure>
    <time_frame>approximately 8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: quantification of GDC-0973-related metabolites in plasma, urine and fecal homogenates</measure>
    <time_frame>approximately 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: plasma concentration of GDC-0973</measure>
    <time_frame>approximately 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: incidence of adverse events</measure>
    <time_frame>approximately 8 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>GDC-0973 Single Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GDC-0973</intervention_name>
    <description>Single oral dose of [14C]-GDC-0973</description>
    <arm_group_label>GDC-0973 Single Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index (BMI) between 18.5 and 29.9 kg/m2, inclusive&#xD;
&#xD;
          -  No clinically significant findings from medical history, 12-lead ECG, and vital signs&#xD;
             and laboratory evaluations&#xD;
&#xD;
          -  Negative test for selected drugs of abuse&#xD;
&#xD;
          -  No infection with hepatitis B, hepatitis C, human immunodeficiency virus (HIV)&#xD;
&#xD;
          -  Sterile or agree to use an adequate contraception method&#xD;
&#xD;
          -  Historically able to produce a minimum of 1 bowel movement per day&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant history or clinical manifestation of any significant metabolic, allergic,&#xD;
             dermatological, hepatic, renal, hematological, pulmonary, cardiovascular,&#xD;
             gastrointestinal, neurological, or psychiatric disorder&#xD;
&#xD;
          -  History of significant hypersensitivity, intolerance, or allergy to any drug compound,&#xD;
             food, or other substance unless approved by the Investigator&#xD;
&#xD;
          -  History of stomach or intestinal surgery or resection (including a cholecystectomy)&#xD;
             that would potentially alter absorption and/or excretion of orally administered drugs&#xD;
             except that appendectomy and/or hernia repair will be allowed&#xD;
&#xD;
          -  History of Gilbert's Syndrome&#xD;
&#xD;
          -  History of diabetes mellitus and/or elevated fasting glucose at baseline&#xD;
&#xD;
          -  History or presence of an abnormal ECG&#xD;
&#xD;
          -  History of alcoholism or drug addiction within 1 year prior Check-in&#xD;
&#xD;
          -  Participation in more than one other radiolabeled investigational study drug trial&#xD;
             within 12 months prior to Check-in&#xD;
&#xD;
          -  Exposure to significant radiation within 12 months prior to Check-in study drug&#xD;
             occurred within 5 half-lives or 30 days, whichever is longer, prior to Check-in&#xD;
&#xD;
          -  Use of any tobacco-containing or nicotine-containing products within 6 months prior to&#xD;
             Check-in&#xD;
&#xD;
          -  Participation in any other investigational study drug or biologic agent trial in which&#xD;
             receipt of an investigational study drug occurred within 5 half-lives or 30 days,&#xD;
             whichever is longer, prior to Check-in&#xD;
&#xD;
          -  Use of any prescription medications/products within 14 days prior to Check-in&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 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>Genentech, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 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/NCT01711762
org study id: GP28369
nct id: NCT01711762
lead sponsor: 
This open-label, non-randomized study will assess the absorption, metabolism, and excretion
      of radioactive-labeled [14C]-GDC-0973 in healthy male volunteers. Volunteers will receive a
      single dose of [14C]-GDC-0973.
allocation: Randomized
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Route of elimination of [14C]-GDC-0973
time frame: approximately 8 weeks
measure: Pharmacokinetics: maximum observed concentration (Cmax)
time frame: approximately 8 weeks
measure: Pharmacokinetics: time to maximum concentration (tmax)
time frame: approximately 8 weeks
measure: Pharmacokinetics: area under the concentration-time curve
time frame: approximately 8 weeks
measure: Pharmacokinetics: apparent terminal elimination phase rate constant
time frame: approximately 8 weeks
measure: Pharmacokinetics: apparent terminal elimination phase half-life
time frame: approximately 8 weeks
measure: Pharmacokinetics: apparent total clearance
time frame: approximately 8 weeks
measure: Pharmacokinetics: apparent volume of distribution
time frame: approximately 8 weeks
measure: Pharmacokinetics: amount total radioactivity in whole blood/urine/feces
time frame: approximately 8 weeks
measure: Pharmacokinetics: quantification of GDC-0973-related metabolites in plasma, urine and fecal homogenates
time frame: approximately 8 weeks
measure: Pharmacokinetics: plasma concentration of GDC-0973
time frame: approximately 8 weeks
measure: Safety: incidence of adverse events
time frame: approximately 8 weeks
arm group label: GDC-0973 Single Arm
arm group type: Experimental
intervention type: Drug
intervention name: GDC-0973
description: Single oral dose of [14C]-GDC-0973
arm group label: GDC-0973 Single Arm
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Trials
role: Study Director
affiliation: Genentech, Inc.
facility: 
country: United States
responsible party type: Sponsor