xml: <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/NCT06012721</url>
    </required_header>
    <id_info>
      <org_study_id>ORIC-114-03</org_study_id>
      <nct_id>NCT06012721</nct_id>
    </id_info>
    <brief_title>Effect of Food on the Pharmacokinetics of ORIC-114</brief_title>
    <official_title>A Phase 1, Randomized, Open-Label, Crossover Study Evaluating the Effect of Food on the Pharmacokinetics of ORIC-114 Tablet Formulation in 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>
      <has_dmc>No</has_dmc>
      <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>
        A randomized, 2-part, 2-sequence, 2-period, open-label, crossover study evaluating the effect&#xD;
        of food on the pharmacokinetics (PK) of ORIC-114 tablet formulation in healthy adult&#xD;
        subjects.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will be performed in two parts. Part 1 will assess the effect of food at a lower&#xD;
        dose of ORIC-114 to first ascertain the degree of food effect (if any) on ORIC-114 exposure&#xD;
        as a way to ensure the safety of the participating subjects. Part 2 will further assess the&#xD;
        food effect at a higher dose of ORIC-114.&#xD;
  &#xD;
        If the preliminary Part 1 results clearly show no food effect, Part 2 may not need to be&#xD;
        conducted upon assessment by the Sponsor.&#xD;
  &#xD;
        If Part 2 is conducted, the dose of ORIC-114 will be selected within the anticipated&#xD;
        efficacious clinical dose range based on results from Part 1.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">November 2023</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>
      <intervention_model_description>Randomized, 2-part, 2-sequence, 2-period, open-label, crossover</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Maximum plasma concentration (Cmax)</measure>
      <time_frame>14 days</time_frame>
      <description>To evaluate the effect of food on the single dose PK of ORIC-114 tablet formulation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time of maximum observed concentration (Tmax)</measure>
      <time_frame>14 days</time_frame>
      <description>Food Effect: PK of ORIC-114 tablet</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Area under the curve (AUC)</measure>
      <time_frame>14 days</time_frame>
      <description>Food Effect: PK of ORIC-114 tablet</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Apparent plasma terminal elimination half-life (t1/2)</measure>
      <time_frame>14 days</time_frame>
      <description>Food Effect: PK of ORIC-114 tablet</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of subjects with Treatment Emergent Adverse Effect</measure>
      <time_frame>30 days</time_frame>
      <description>Assessed by NCI CTCAE v5.0</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">32</enrollment>
    <condition>Food Effect in Healthy Participants</condition>
    <arm_group>
      <arm_group_label>Part 1 Treatment A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>30 mg ORIC-114 (3 x 10 mg tablets) administered at Hour 0 on Day 1 under fasting conditions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 1 Treatment B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>30 mg ORIC 114 (3 x 10 mg tablets) administered at Hour 0 on Day 1, 30 minutes after the start of a meal.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 2 Treatment A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>xx mg ORIC-114 (n x 10 mg tablets) administered at Hour 0 on Day 1 under fasting conditions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 2 Treatment B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>xx mg ORIC 114 (n x 10 mg tablets) administered at Hour 0 on Day 1, 30 minutes after the start of a meal.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>ORIC-114</intervention_name>
      <description>Food effect healthy subjects</description>
      <arm_group_label>Part 1 Treatment A</arm_group_label>
      <arm_group_label>Part 1 Treatment B</arm_group_label>
      <arm_group_label>Part 2 Treatment A</arm_group_label>
      <arm_group_label>Part 2 Treatment B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Healthy, adult, male or female (of nonchildbearing potential only), 18-55 years of age&#xD;
  &#xD;
            2. Continuous nonsmoker who has not used nicotine and tobacco containing products for at&#xD;
               least 30 days&#xD;
  &#xD;
            3. Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2&#xD;
  &#xD;
            4. Medically healthy with no clinically significant medical history, physical&#xD;
               examination, laboratory profiles, vital signs, and ECGs, as deemed by the PI or&#xD;
               designee&#xD;
  &#xD;
            5. Able to swallow multiple tablets.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Mentally or legally incapacitated or has significant emotional problems&#xD;
  &#xD;
            2. History or presence of clinically significant medical or psychiatric condition or&#xD;
               disease in the opinion of the PI or designee.&#xD;
  &#xD;
            3. History or presence of alcohol or drug abuse within the past 2 years prior to the&#xD;
               first dosing.&#xD;
  &#xD;
            4. History or presence of clinically significant GI disorder (&#xD;
  &#xD;
            5. Female subjects of childbearing potential.&#xD;
  &#xD;
            6. Positive urine drug screen or alcohol breath test results&#xD;
  &#xD;
            7. Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen&#xD;
               (HBsAg), or hepatitis C virus (HCV)&#xD;
  &#xD;
            8. Lactose intolerant.&#xD;
        </textblock>
      </criteria>
      <gender>All</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>Pratik S Multani, MD, MS</last_name>
      <role>Study Director</role>
      <affiliation>ORIC Pharmaceuticals</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>ORIC Clinical</last_name>
      <phone>650-388-5600</phone>
      <email>clinical@oricpharma.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Nucleus Network Pty Ltd., 235 Ryrie St</name>
        <address>
          <city>Geelong</city>
          <state>Victoria</state>
          <zip>3220</zip>
          <country>Australia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Nucleus Network Pty Ltd., Level 5, Burnet Tower, 89 Commercial Rd</name>
        <address>
          <city>Melbourne</city>
          <state>Victoria</state>
          <zip>3004</zip>
          <country>Australia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Australia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Food effect</keyword>
    <keyword>ORIC-114</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06012721
  org study id: ORIC-114-03
  nct id: NCT06012721
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  A randomized, 2-part, 2-sequence, 2-period, open-label, crossover study evaluating the effect
        of food on the pharmacokinetics (PK) of ORIC-114 tablet formulation in healthy adult
        subjects.
  The study will be performed in two parts. Part 1 will assess the effect of food at a lower
        dose of ORIC-114 to first ascertain the degree of food effect (if any) on ORIC-114 exposure
        as a way to ensure the safety of the participating subjects. Part 2 will further assess the
        food effect at a higher dose of ORIC-114.
  
        If the preliminary Part 1 results clearly show no food effect, Part 2 may not need to be
        conducted upon assessment by the Sponsor.
  
        If Part 2 is conducted, the dose of ORIC-114 will be selected within the anticipated
        efficacious clinical dose range based on results from Part 1.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Randomized, 2-part, 2-sequence, 2-period, open-label, crossover
  primary purpose: Other
  masking: None (Open Label)
  measure: Maximum plasma concentration (Cmax)
  time frame: 14 days
  description: To evaluate the effect of food on the single dose PK of ORIC-114 tablet formulation
  measure: Time of maximum observed concentration (Tmax)
  time frame: 14 days
  description: Food Effect: PK of ORIC-114 tablet
  measure: Area under the curve (AUC)
  time frame: 14 days
  description: Food Effect: PK of ORIC-114 tablet
  measure: Apparent plasma terminal elimination half-life (t1/2)
  time frame: 14 days
  description: Food Effect: PK of ORIC-114 tablet
  measure: Number of subjects with Treatment Emergent Adverse Effect
  time frame: 30 days
  description: Assessed by NCI CTCAE v5.0
  arm group label: Part 1 Treatment A
  arm group type: Experimental
  description: 30 mg ORIC-114 (3 x 10 mg tablets) administered at Hour 0 on Day 1 under fasting conditions.
  arm group label: Part 1 Treatment B
  arm group type: Experimental
  description: 30 mg ORIC 114 (3 x 10 mg tablets) administered at Hour 0 on Day 1, 30 minutes after the start of a meal.
  arm group label: Part 2 Treatment A
  arm group type: Experimental
  description: xx mg ORIC-114 (n x 10 mg tablets) administered at Hour 0 on Day 1 under fasting conditions.
  arm group label: Part 2 Treatment B
  arm group type: Experimental
  description: xx mg ORIC 114 (n x 10 mg tablets) administered at Hour 0 on Day 1, 30 minutes after the start of a meal.
  intervention type: Drug
  intervention name: ORIC-114
  description: Food effect healthy subjects
  arm group label: Part 1 Treatment A
  arm group label: Part 1 Treatment B
  arm group label: Part 2 Treatment A
  arm group label: Part 2 Treatment B
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Pratik S Multani, MD, MS
  role: Study Director
  affiliation: ORIC Pharmaceuticals
  last name: ORIC Clinical
  phone: 650-388-5600
  email: clinical@oricpharma.com
  facility: 
  facility: 
  country: Australia
  responsible party type: Sponsor
  sharing ipd: No