<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/NCT03807739</url>
  </required_header>
  <id_info>
    <org_study_id>GP40957</org_study_id>
    <nct_id>NCT03807739</nct_id>
  </id_info>
  <brief_title>A Study to Determine the Bioavailability of Various Formulations of GDC-0134 in Healthy Female Participants of Non-Childbearing Potential</brief_title>
  <official_title>A Phase I Study to Determine the Relative Bioavailability of Various Formulations of GDC-0134 in Healthy Female Subjects of Non-Childbearing Potential</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Genentech, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Genentech, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a two-part study to determine the relative bioavailability of two different prototype&#xD;
      capsules of GDC-0134 to that of an existing reference capsule of GDC-0134 under both fed and&#xD;
      fasted conditions. The study is open to healthy female participants of non-childbearing&#xD;
      potential.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">May 30, 2019</completion_date>
  <primary_completion_date type="Actual">May 30, 2019</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Observed Concentration (Cmax) of GDC-0134.</measure>
    <time_frame>The time points at which the outcome measure was assessed were 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 336, 504 hours post-dose.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve Extrapolated to Infinity (AUCinf) of GDC-0134</measure>
    <time_frame>The time points at which the outcome measure was assessed were 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 336, 504 hours post-dose.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Adverse Events (AEs)</measure>
    <time_frame>From baseline through the end of study (approximately 11 weeks)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Part I: GDC-0134 F16 vs F09 Capsule Formulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Part 1 participants will receive single doses of either GDC-0134 F16 capsules (prototype) or GDC-0134 F09 capsules (reference) after having consumed a standard meal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part II: GDC-0134 F15 vs F09 Capsule Formulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Part 2, participants will receive a single dose of either GDC-0134 F15 capsules (prototype) or GDC-0134 F09 capsules (reference) after an overnight fast.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GDC-0134 F09 Formulation</intervention_name>
    <description>Participants will receive a single oral dose of GDC-0134 reference capsule F09.</description>
    <arm_group_label>Part I: GDC-0134 F16 vs F09 Capsule Formulation</arm_group_label>
    <arm_group_label>Part II: GDC-0134 F15 vs F09 Capsule Formulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GDC-0134 F15 Formulation</intervention_name>
    <description>Participants will receive a single oral dose of GDC-0134 prototype capsule F15.</description>
    <arm_group_label>Part II: GDC-0134 F15 vs F09 Capsule Formulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GDC-0134 F16 Formulation</intervention_name>
    <description>Participants will receive a single oral dose of GDC-0134 prototype capsule F16.</description>
    <arm_group_label>Part I: GDC-0134 F16 vs F09 Capsule Formulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Body mass index (BMI) range 18.5 to 35 kilograms per square meter (kg/m2)&#xD;
&#xD;
          -  In good health, determined by no clinically significant findings from medical history,&#xD;
             physical examination, 12-lead ECG, and vital signs;&#xD;
&#xD;
          -  Clinical laboratory evaluations within the reference range for the test laboratory,&#xD;
             unless deemed not clinically significant by the principal investigators (PIs)&#xD;
&#xD;
          -  Females of non-childbearing potential only&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  History or clinical manifestation of any significant medical condition as determined&#xD;
             by the PI (or designee)&#xD;
&#xD;
          -  History of significant hypersensitivity, intolerance, or allergy to any drug compound,&#xD;
             food, or other substance, unless approved by the PI (or designee)&#xD;
&#xD;
          -  History of stomach or intestinal surgery or resection that would potentially alter&#xD;
             absorption and/or excretion of orally administered drugs&#xD;
&#xD;
          -  Use of any prescription medications/products within 14 days prior to Check-in (Day -1)&#xD;
             for their first treatment period and during the entire study duration, unless deemed&#xD;
             acceptable by the PI&#xD;
&#xD;
          -  Use of oral antibiotics within 4 weeks or intravenous antibiotics within 8 weeks prior&#xD;
             to the Screening evaluation and during the entire study duration&#xD;
&#xD;
          -  Use of any over-the-counter, non-prescription preparations within 14 days prior to&#xD;
             Check-in (Day -1) for their first treatment period and during the entire study&#xD;
             duration, unless deemed acceptable by the PI&#xD;
&#xD;
          -  Use of acid reducing medications (proton pump inhibitors [PPIs], histamine H2-receptor&#xD;
             antagonists [H2RAs]) within 14 days prior to Check-in (Day -1) for their first&#xD;
             treatment period and during the entire study duration. As an alternative, antacids may&#xD;
             be allowed at least 4 hours before or after dose&#xD;
&#xD;
          -  Use of any vaccines (including seasonal flu and H1N1 vaccines) within 14 days prior to&#xD;
             Check-in (Day -1) for their first treatment period&#xD;
&#xD;
          -  Use of tobacco- or nicotine-containing products within 6 months prior to Check-in (Day&#xD;
             -1) for their first treatment period and during the entire study&#xD;
&#xD;
          -  Any acute or chronic condition or any other reason that, in the opinion of the PI,&#xD;
             would limit the subject's ability to complete and/or participate in this clinical&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Healthy female participants of non-childbearing potential</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 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>
      <name>Covance Research Unit - Daytona</name>
      <address>
        <city>Daytona Beach</city>
        <state>Florida</state>
        <zip>32117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Covance Research Unit - Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75247</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <results_first_submitted>April 28, 2020</results_first_submitted>
  <results_first_submitted_qc>August 24, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 31, 2020</results_first_posted>
  <last_update_submitted>August 24, 2020</last_update_submitted>
  <last_update_submitted_qc>August 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT03807739/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 1, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT03807739/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Screening period: Day -28 to Day 2</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Part 1: GDC-0134 F09 vs GDC-0134 F16 Capsule Formulation</title>
          <description>In Part 1 participants received single doses of either GDC-0134 F09 or GDC-0134 F16 capsules (prototype) after having consumed a standard meal.</description>
        </group>
        <group group_id="P2">
          <title>Part 1: GDC-0134 F16 vs GDC-0134 F09 Capsule Formulation</title>
          <description>In Part 1, participants received a single dose of either GDC-0134 F16 capsules or GDC-0134 F09 capsules after after having consumed a standard meal.</description>
        </group>
        <group group_id="P3">
          <title>Part 2: GDC-0134 F09 vs GDC-0134 F15 Capsule Formulation</title>
          <description>In Part 2 participants received single doses of either GDC-0134 F09 or GDC-0134 F15 capsules (prototype) in fasting conditions.</description>
        </group>
        <group group_id="P4">
          <title>Part 2: GDC-0134 F15 vs GDC-0134 F09 Capsule Formulation</title>
          <description>In Part 2 participants received single doses of either GDC-0134 F15 or GDC-0134 F09 capsules (prototype) in fasting conditions.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Part I: GDC-0134 F09 vs GDC-0134 F16 Capsule Formulation</title>
          <description>In Part 1 participants received single doses of either GDC-0134 F09 capsules (prototype) or GDC-0134 F16 capsules (reference) after having consumed a standard meal.</description>
        </group>
        <group group_id="B2">
          <title>Part 1: GDC-0134 F16 vs GDC-0134 F09 Capsule Formulation</title>
          <description>In Part 1, participants received a single dose of either GDC-0134 F16 capsules or GDC-0134 F09 capsules after after having consumed a standard meal.</description>
        </group>
        <group group_id="B3">
          <title>Part 2: GDC-0134 F09 vs GDC-0134 F15 Capsule Formulation</title>
          <description>In Part 2 participants received single doses of either GDC-0134 F09 or GDC-0134 F15 capsules (prototype) in fasting conditions.</description>
        </group>
        <group group_id="B4">
          <title>Part 2: GDC-0134 F15 vs GDC-0134 F09 Capsule Formulation</title>
          <description>In Part 2 participants received single doses of either GDC-0134 F15 or GDC-0134 F09 capsules (prototype) in fasting conditions.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="9"/>
            <count group_id="B4" value="10"/>
            <count group_id="B5" value="38"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.3" spread="8.9"/>
                    <measurement group_id="B2" value="56.5" spread="4.8"/>
                    <measurement group_id="B3" value="52.6" spread="7.2"/>
                    <measurement group_id="B4" value="58.8" spread="3.1"/>
                    <measurement group_id="B5" value="56.1" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74.5" spread="12.5"/>
                    <measurement group_id="B2" value="68.9" spread="10.9"/>
                    <measurement group_id="B3" value="73.4" spread="15.6"/>
                    <measurement group_id="B4" value="71.5" spread="10.0"/>
                    <measurement group_id="B5" value="72.0" spread="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="162.9" spread="7.6"/>
                    <measurement group_id="B2" value="161.2" spread="5.8"/>
                    <measurement group_id="B3" value="159.1" spread="6.6"/>
                    <measurement group_id="B4" value="160.6" spread="5.0"/>
                    <measurement group_id="B5" value="160.9" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.1" spread="4.2"/>
                    <measurement group_id="B2" value="26.7" spread="5.0"/>
                    <measurement group_id="B3" value="159.1" spread="4.4"/>
                    <measurement group_id="B4" value="27.9" spread="5.1"/>
                    <measurement group_id="B5" value="27.8" spread="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Maximum Observed Concentration (Cmax) of GDC-0134.</title>
        <time_frame>The time points at which the outcome measure was assessed were 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 336, 504 hours post-dose.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Part 1 GDC-0134 F16 Capsule Fed</title>
            <description>In Part 1 participants received single doses of GDC-0134 F16 after having consumed a standard meal.</description>
          </group>
          <group group_id="O2">
            <title>Part 1 GDC-0134 F09 Capsule Fed</title>
            <description>In Part I participants received single doses of GDC-0134 F09 capsules after having consumed a standard meal.</description>
          </group>
          <group group_id="O3">
            <title>Part 2 GDC-0134 F15 Fasted</title>
            <description>In Part 2, participants received a single dose of GDC-0134 F15 capsules after an overnight fast.</description>
          </group>
          <group group_id="O4">
            <title>Part 2 GDC-0134 F09 Capsule Fasted</title>
            <description>In Part 2, participants received a single dose of GDC-0134 F09 capsules after an overnight fast.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Concentration (Cmax) of GDC-0134.</title>
          <units>uM</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.56" spread="85.2"/>
                    <measurement group_id="O2" value="4.45" spread="93.7"/>
                    <measurement group_id="O3" value="2.66" spread="131.5"/>
                    <measurement group_id="O4" value="2.68" spread="140.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence margin 80% - 125%</non_inferiority_desc>
            <param_type>Geometric LS Mean Ratio</param_type>
            <param_value>1.2471</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.1149</ci_lower_limit>
            <ci_upper_limit>1.3951</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence margin 80% - 125%</non_inferiority_desc>
            <param_type>Geometric LS Mean Ratio</param_type>
            <param_value>0.9864</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.8531</ci_lower_limit>
            <ci_upper_limit>1.1405</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Adverse Events (AEs)</title>
        <time_frame>From baseline through the end of study (approximately 11 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Part I: GDC-0134 F09 vs GDC-0134 F16 Capsule Formulation</title>
            <description>In Part 1 participants received single doses of either GDC-0134 F09 capsules (prototype) or GDC-0134 F16 capsules (reference) after having consumed a standard meal.</description>
          </group>
          <group group_id="O2">
            <title>Part II: GDC-0134 F15 vs F09 Capsule Formulation</title>
            <description>In Part 2, participants received a single dose of either GDC-0134 F15 capsules (prototype) or GDC-0134 F09 capsules (reference) after an overnight fast.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Adverse Events (AEs)</title>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.2"/>
                    <measurement group_id="O2" value="52.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Curve Extrapolated to Infinity (AUCinf) of GDC-0134</title>
        <time_frame>The time points at which the outcome measure was assessed were 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 336, 504 hours post-dose.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Part 1 GDC-0134 F16 Capsule Fed</title>
            <description>In Part 1 participants received single doses of GDC-0134 F16 after having consumed a standard meal.</description>
          </group>
          <group group_id="O2">
            <title>Part 1 GDC-0134 F09 Capsule Fed</title>
            <description>In Part I participants received single doses of GDC-0134 F09 capsules after having consumed a standard meal.</description>
          </group>
          <group group_id="O3">
            <title>Part 2 GDC-0134 F15 Fasted</title>
            <description>In Part 2, participants received a single dose of GDC-0134 F15 capsules after an overnight fast.</description>
          </group>
          <group group_id="O4">
            <title>Part 2 GDC-0134 F09 Capsule Fasted</title>
            <description>In Part 2, participants received a single dose of GDC-0134 F09 capsules after an overnight fast.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve Extrapolated to Infinity (AUCinf) of GDC-0134</title>
          <units>uM.h</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="190" spread="78.7"/>
                    <measurement group_id="O2" value="154" spread="94.9"/>
                    <measurement group_id="O3" value="84.8" spread="103.4"/>
                    <measurement group_id="O4" value="85.6" spread="103.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence margin 80% - 125%</non_inferiority_desc>
            <param_type>Geometric LS Mean Ratio</param_type>
            <param_value>1.2203</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.1175</ci_lower_limit>
            <ci_upper_limit>1.3327</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence margin 80% - 125%</non_inferiority_desc>
            <param_type>Geometric LS Mean Ratio</param_type>
            <param_value>0.9947</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.8266</ci_lower_limit>
            <ci_upper_limit>1.1968</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From baseline up to 4 months</time_frame>
      <desc>The pre-specified intent of the study was to assess the adverse events in participants receiving GDC-0134, regardless of which formulation was given (e.g., F09 vs F16), therefore, all participants receiving GDC-0134 are combined into a single Arm, for each part.</desc>
      <group_list>
        <group group_id="E1">
          <title>Part I: GDC-0134 F09 vs GDC-0134 F16 Capsule Formulation</title>
          <description>In Part 1 participants received single doses of either GDC-0134 F09 capsules (prototype) or GDC-0134 F16 capsules (reference) after having consumed a standard meal.</description>
        </group>
        <group group_id="E2">
          <title>Part II: GDC-0134 F15 vs F09 Capsule Formulation</title>
          <description>In Part 2, participants received a single dose of either GDC-0134 F15 capsules (prototype) or GDC-0134 F09 capsules (reference) after an overnight fast.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedRA 21.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Vessel puncture site swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Haematocrit decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Mean cell volume decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="19"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Photosensitivity reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Genentech, Inc</organization>
      <phone>1-800-821-8590</phone>
      <email>genentech@druginfo.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03807739
org study id: GP40957
nct id: NCT03807739
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This is a two-part study to determine the relative bioavailability of two different prototype
      capsules of GDC-0134 to that of an existing reference capsule of GDC-0134 under both fed and
      fasted conditions. The study is open to healthy female participants of non-childbearing
      potential.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Observed Concentration (Cmax) of GDC-0134.
time frame: The time points at which the outcome measure was assessed were 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 336, 504 hours post-dose.
measure: Area Under the Curve Extrapolated to Infinity (AUCinf) of GDC-0134
time frame: The time points at which the outcome measure was assessed were 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 336, 504 hours post-dose.
measure: Percentage of Participants With Adverse Events (AEs)
time frame: From baseline through the end of study (approximately 11 weeks)
arm group label: Part I: GDC-0134 F16 vs F09 Capsule Formulation
arm group type: Experimental
description: In Part 1 participants will receive single doses of either GDC-0134 F16 capsules (prototype) or GDC-0134 F09 capsules (reference) after having consumed a standard meal.
arm group label: Part II: GDC-0134 F15 vs F09 Capsule Formulation
arm group type: Experimental
description: In Part 2, participants will receive a single dose of either GDC-0134 F15 capsules (prototype) or GDC-0134 F09 capsules (reference) after an overnight fast.
intervention type: Drug
intervention name: GDC-0134 F09 Formulation
description: Participants will receive a single oral dose of GDC-0134 reference capsule F09.
arm group label: Part I: GDC-0134 F16 vs F09 Capsule Formulation
arm group label: Part II: GDC-0134 F15 vs F09 Capsule Formulation
intervention type: Drug
intervention name: GDC-0134 F15 Formulation
description: Participants will receive a single oral dose of GDC-0134 prototype capsule F15.
arm group label: Part II: GDC-0134 F15 vs F09 Capsule Formulation
intervention type: Drug
intervention name: GDC-0134 F16 Formulation
description: Participants will receive a single oral dose of GDC-0134 prototype capsule F16.
arm group label: Part I: GDC-0134 F16 vs F09 Capsule Formulation
criteria: 
gender: Female
gender based: Yes
gender description: Healthy female participants of non-childbearing potential
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
facility: 
country: United States
responsible party type: Sponsor
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 