<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/NCT03835637</url>
  </required_header>
  <id_info>
    <org_study_id>ORIC-GR-17002</org_study_id>
    <nct_id>NCT03835637</nct_id>
  </id_info>
  <brief_title>Single and Multiple Dose Study of ORIC-101 in Adult Healthy Subjects</brief_title>
  <official_title>A Phase 1 Study of the Oral Glucocorticoid Receptor (GR) Antagonist ORIC-101 in Adult Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ORIC Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ORIC Pharmaceuticals</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single centre, open-label, non-randomised study with up to 2 parts, assessing the&#xD;
      safety, tolerability, PK and PD of single (Part A) and multiple (Part B; optional) doses of&#xD;
      oral GR antagonist ORIC-101.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 23, 2018</start_date>
  <completion_date type="Actual">July 4, 2018</completion_date>
  <primary_completion_date type="Actual">July 4, 2018</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>Sequential Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum plasma concentration (Cmax)</measure>
    <time_frame>96 hours post-final dose</time_frame>
    <description>PK of ORIC-101 as single doses</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the curve (AUC)</measure>
    <time_frame>96 hours post-final dose</time_frame>
    <description>PK of ORIC-101 as single doses</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>96 hours post-final dose</time_frame>
    <description>Safety and tolerability of ORIC-101 as single doses</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Laboratory Values</measure>
    <time_frame>96 hours post-final dose</time_frame>
    <description>Safety and tolerability of ORIC-101 as single doses</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration (Cmax)</measure>
    <time_frame>96 hours post-final dose</time_frame>
    <description>Comparison of the PK of ORIC-101 in the presence or absence of food</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve (AUC)</measure>
    <time_frame>96 hours post-final dose</time_frame>
    <description>Comparison of the PK of ORIC-101 in the presence or absence of food</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>96 hours post-final dose</time_frame>
    <description>Safety and tolerability of ORIC-101 as multiple doses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Laboratory Values</measure>
    <time_frame>96 hours post-final dose</time_frame>
    <description>Safety and tolerability of ORIC-101 as multiple doses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration (Cmax)</measure>
    <time_frame>96 hours post-final dose</time_frame>
    <description>PK of ORIC-101 as multiple doses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve (AUC)</measure>
    <time_frame>96 hours post-final dose</time_frame>
    <description>PK of ORIC-101 as multiple doses</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Regimen A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Regimen B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Regimen C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Regimen D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Regimen F</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Regimen H</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Regimen I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ORIC-101</intervention_name>
    <description>Capsule or oral suspension</description>
    <arm_group_label>Regimen A</arm_group_label>
    <arm_group_label>Regimen B</arm_group_label>
    <arm_group_label>Regimen C</arm_group_label>
    <arm_group_label>Regimen D</arm_group_label>
    <arm_group_label>Regimen F</arm_group_label>
    <arm_group_label>Regimen H</arm_group_label>
    <arm_group_label>Regimen I</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males or healthy females of non-child bearing potential&#xD;
&#xD;
          -  Age 18 to 65 years of age&#xD;
&#xD;
          -  Body mass index of 18.0 to 32.0 kg/m^2 and weight between 50 kg and 120 kg, inclusive&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have received any investigational medicinal product (IMP) in a clinical&#xD;
             research study within the previous 3 months&#xD;
&#xD;
          -  History of any drug or alcohol abuse in the past 2 years&#xD;
&#xD;
          -  Current smokers and those who have smoked within the last 12 months&#xD;
&#xD;
          -  Females of childbearing potential&#xD;
&#xD;
          -  Women with a history of unexplained vaginal bleeding or endometrial hyperplasia with&#xD;
             atypia or endometrial carcinoma&#xD;
&#xD;
          -  Current disease requiring treatment with systemic corticosteroids&#xD;
&#xD;
          -  Serious adverse reaction or serious hypersensitivity to mifepristone, or any other&#xD;
             drug, or the formulation excipients&#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>
  <location>
    <facility>
      <name>Research Center</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>February 7, 2019</last_update_submitted>
  <last_update_submitted_qc>February 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2019</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/NCT03835637
org study id: ORIC-GR-17002
nct id: NCT03835637
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a single centre, open-label, non-randomised study with up to 2 parts, assessing the
      safety, tolerability, PK and PD of single (Part A) and multiple (Part B; optional) doses of
      oral GR antagonist ORIC-101.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Maximum plasma concentration (Cmax)
time frame: 96 hours post-final dose
description: PK of ORIC-101 as single doses
measure: Area under the curve (AUC)
time frame: 96 hours post-final dose
description: PK of ORIC-101 as single doses
measure: Number of participants with adverse events
time frame: 96 hours post-final dose
description: Safety and tolerability of ORIC-101 as single doses
measure: Number of Participants With Abnormal Laboratory Values
time frame: 96 hours post-final dose
description: Safety and tolerability of ORIC-101 as single doses
measure: Maximum plasma concentration (Cmax)
time frame: 96 hours post-final dose
description: Comparison of the PK of ORIC-101 in the presence or absence of food
measure: Area under the curve (AUC)
time frame: 96 hours post-final dose
description: Comparison of the PK of ORIC-101 in the presence or absence of food
measure: Number of participants with adverse events
time frame: 96 hours post-final dose
description: Safety and tolerability of ORIC-101 as multiple doses
measure: Number of Participants With Abnormal Laboratory Values
time frame: 96 hours post-final dose
description: Safety and tolerability of ORIC-101 as multiple doses
measure: Maximum plasma concentration (Cmax)
time frame: 96 hours post-final dose
description: PK of ORIC-101 as multiple doses
measure: Area under the curve (AUC)
time frame: 96 hours post-final dose
description: PK of ORIC-101 as multiple doses
arm group label: Regimen A
arm group type: Experimental
arm group label: Regimen B
arm group type: Experimental
arm group label: Regimen C
arm group type: Experimental
arm group label: Regimen D
arm group type: Experimental
arm group label: Regimen F
arm group type: Experimental
arm group label: Regimen H
arm group type: Experimental
arm group label: Regimen I
arm group type: Experimental
intervention type: Drug
intervention name: ORIC-101
description: Capsule or oral suspension
arm group label: Regimen A
arm group label: Regimen B
arm group label: Regimen C
arm group label: Regimen D
arm group label: Regimen F
arm group label: Regimen H
arm group label: Regimen I
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor