<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/NCT03290703</url>
  </required_header>
  <id_info>
    <org_study_id>GP39619</org_study_id>
    <secondary_id>2017-000752-26</secondary_id>
    <nct_id>NCT03290703</nct_id>
  </id_info>
  <brief_title>A Study to Investigate the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics (PK) of GDC-0853 in Healthy Participants</brief_title>
  <official_title>A Phase I, Single Center, Randomized, Open-Label Study Investigating the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics of GDC-0853 in Healthy Subjects</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>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the PK of GDC-0853 following changes to formulation&#xD;
      and in the presence or absence of food, the proton pump inhibitor (rabeprazole), or both.&#xD;
      This will be a 3-part open-label randomized study conducted in healthy adult participants.&#xD;
      Approximately 63 subjects will be enrolled in this study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 18, 2017</start_date>
  <completion_date type="Actual">October 25, 2018</completion_date>
  <primary_completion_date type="Actual">October 25, 2018</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 Plasma Concentration (Cmax) of GDC-0853</measure>
    <time_frame>Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax) of GDC-0853</measure>
    <time_frame>Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Measurable Concentration [AUC (0-t)] of GDC-0853</measure>
    <time_frame>Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of GDC-0853</measure>
    <time_frame>Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Extrapolated Area Under the Curve (AUC Percent [%] Extrap) of GDC-0853</measure>
    <time_frame>Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Terminal Elimination Rate Constant of GDC-0853</measure>
    <time_frame>Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Volume of Distribution (Vz/F) of GDC-0853</measure>
    <time_frame>Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Oral Clearance (CL/F) of GDC-0853</measure>
    <time_frame>Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Relative Bioavailability (Frel) of GDC-0853</measure>
    <time_frame>Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Terminal Elimination Half-Life (t1/2) of GDC-0853</measure>
    <time_frame>Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Adverse Events (AEs)</measure>
    <time_frame>From screening to the end of the study (approximately a maximum of 11 weeks)</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Part 1: GDC-0853 (Effect of Formulation)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive five single oral doses of test formulations of GDC-0853 co-administered with rabeprazole in the fasted state.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: GDC-0853 (Effect of Food and Rabeprazole)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive three single oral doses of one GDC-0853 formulations selected from Part 1 of this study. One dose will be administered in the fasted state, one dose will be administered in the fed state, and one dose will be co-administered with rabeprazole in the fed or fasted state, depending on randomization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 3: GDC-0853 Optimized (Effect of Food and Rabeprazole)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive three single oral doses of an optimized tablet formulations of GDC-0853. One dose will be administered in the fasted state, one dose will be administered in the fed state, and one dose will be co-administered with rabeprazole in the fed or fasted state, depending on randomization.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GDC-0853</intervention_name>
    <description>Participants will receive different formulations of GDC-0853 tablet.</description>
    <arm_group_label>Part 1: GDC-0853 (Effect of Formulation)</arm_group_label>
    <arm_group_label>Part 2: GDC-0853 (Effect of Food and Rabeprazole)</arm_group_label>
    <arm_group_label>Part 3: GDC-0853 Optimized (Effect of Food and Rabeprazole)</arm_group_label>
    <other_name>RO7010939</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rabeprazole</intervention_name>
    <description>Participants will receive rabeprazole 20 mg twice daily (BID) for three days prior to GDC-0853 administration and a single dose coadministered with GDC-0853.</description>
    <arm_group_label>Part 1: GDC-0853 (Effect of Formulation)</arm_group_label>
    <arm_group_label>Part 2: GDC-0853 (Effect of Food and Rabeprazole)</arm_group_label>
    <arm_group_label>Part 3: GDC-0853 Optimized (Effect of Food and Rabeprazole)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female (of non-childbearing potential) participants&#xD;
&#xD;
          -  Within body mass index range 18.0 to 32.0 kilogram per meter square (kg/m^2),&#xD;
             inclusive&#xD;
&#xD;
          -  In good health, determined by no clinically significant findings from medical history,&#xD;
             12-lead electrocardiogram (ECG), vital signs and physical examinations&#xD;
&#xD;
          -  For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use&#xD;
             contraceptive measures, and agreement to refrain from donating sperm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or symptoms of any significant disease&#xD;
&#xD;
          -  History of significant hypersensitivity, intolerance, or allergy to any drug compound,&#xD;
             food, or other substance&#xD;
&#xD;
          -  History of stomach or intestinal surgery or resection&#xD;
&#xD;
          -  Participants who previously participated in any other investigational study drug trial&#xD;
             within 90 days prior to Check-in. Participants who previously received GDC-0853 in&#xD;
             previous studies.&#xD;
&#xD;
          -  History of malignancy&#xD;
&#xD;
          -  Pregnancy, lactation, or breastfeeding in female participants&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <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 Trial</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Quotient Clinical Ltd, Clinical Research Unit</name>
      <address>
        <city>Nottingham</city>
        <zip>NG11 6JS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>September 10, 2019</last_update_submitted>
  <last_update_submitted_qc>September 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2019</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>Rabeprazole</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/NCT03290703
org study id: GP39619
secondary id: 2017-000752-26
nct id: NCT03290703
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the PK of GDC-0853 following changes to formulation
      and in the presence or absence of food, the proton pump inhibitor (rabeprazole), or both.
      This will be a 3-part open-label randomized study conducted in healthy adult participants.
      Approximately 63 subjects will be enrolled in this study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Observed Plasma Concentration (Cmax) of GDC-0853
time frame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of GDC-0853
time frame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
measure: Area Under the Curve From Time Zero to Last Measurable Concentration [AUC (0-t)] of GDC-0853
time frame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of GDC-0853
time frame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
measure: Extrapolated Area Under the Curve (AUC Percent [%] Extrap) of GDC-0853
time frame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
measure: Apparent Terminal Elimination Rate Constant of GDC-0853
time frame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
measure: Apparent Volume of Distribution (Vz/F) of GDC-0853
time frame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
measure: Apparent Oral Clearance (CL/F) of GDC-0853
time frame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
measure: Relative Bioavailability (Frel) of GDC-0853
time frame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
measure: Apparent Terminal Elimination Half-Life (t1/2) of GDC-0853
time frame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
measure: Percentage of Participants With Adverse Events (AEs)
time frame: From screening to the end of the study (approximately a maximum of 11 weeks)
arm group label: Part 1: GDC-0853 (Effect of Formulation)
arm group type: Experimental
description: Participants will receive five single oral doses of test formulations of GDC-0853 co-administered with rabeprazole in the fasted state.
arm group label: Part 2: GDC-0853 (Effect of Food and Rabeprazole)
arm group type: Experimental
description: Participants will receive three single oral doses of one GDC-0853 formulations selected from Part 1 of this study. One dose will be administered in the fasted state, one dose will be administered in the fed state, and one dose will be co-administered with rabeprazole in the fed or fasted state, depending on randomization.
arm group label: Part 3: GDC-0853 Optimized (Effect of Food and Rabeprazole)
arm group type: Experimental
description: Participants will receive three single oral doses of an optimized tablet formulations of GDC-0853. One dose will be administered in the fasted state, one dose will be administered in the fed state, and one dose will be co-administered with rabeprazole in the fed or fasted state, depending on randomization.
intervention type: Drug
intervention name: GDC-0853
description: Participants will receive different formulations of GDC-0853 tablet.
arm group label: Part 1: GDC-0853 (Effect of Formulation)
arm group label: Part 2: GDC-0853 (Effect of Food and Rabeprazole)
arm group label: Part 3: GDC-0853 Optimized (Effect of Food and Rabeprazole)
other name: RO7010939
intervention type: Drug
intervention name: Rabeprazole
description: Participants will receive rabeprazole 20 mg twice daily (BID) for three days prior to GDC-0853 administration and a single dose coadministered with GDC-0853.
arm group label: Part 1: GDC-0853 (Effect of Formulation)
arm group label: Part 2: GDC-0853 (Effect of Food and Rabeprazole)
arm group label: Part 3: GDC-0853 Optimized (Effect of Food and Rabeprazole)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Trial
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Rabeprazole