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/NCT05999513</url>
    </required_header>
    <id_info>
      <org_study_id>ARC-28</org_study_id>
      <nct_id>NCT05999513</nct_id>
    </id_info>
    <brief_title>A Relative Bioavailability Study and Food Effect Study of AB521 in Healthy Adult Volunteers</brief_title>
    <acronym>ARC-28</acronym>
    <official_title>A Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, 3-Way Crossover, Pharmacokinetic Study to Evaluate the Relative Bioavailability of AB521 Tablet and Capsule Formulations and the Effect of Food on the Pharmacokinetics of the Tablet Formulation in Healthy Adult Volunteers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Arcus Biosciences, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Arcus Biosciences, Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary purpose of this study is to compare the single-dose pharmacokinetics (PK) of&#xD;
        AB521 tablet versus the AB521 capsule, and to evaluate the effect of food on the single-dose&#xD;
        PK of AB521 tablet in healthy adult volunteers.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 21, 2023</start_date>
    <completion_date type="Anticipated">October 2023</completion_date>
    <primary_completion_date type="Anticipated">October 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Area Under the Plasma Drug Concentration-Time Curve (AUC)</measure>
      <time_frame>Predose, Up to 168 hours postdose</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum Concentration (Cmax)</measure>
      <time_frame>Predose, Up to 168 hours postdose</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Time to Maximum Concentration (Tmax)</measure>
      <time_frame>Predose, Up to 168 hours postdose</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Terminal Half-Life Time (t1/2)</measure>
      <time_frame>Predose, Up to 168 hours postdose</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Apparent Total Plasma Clearance (CL/F)</measure>
      <time_frame>Predose, Up to 168 hours postdose</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)</measure>
      <time_frame>Predose, Up to 168 hours postdose</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Adverse Events</measure>
      <time_frame>Up to 10 weeks</time_frame>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Healthy Participants</condition>
    <arm_group>
      <arm_group_label>AB521 - Sequence ABC</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will sequentially receive AB521 capsules fasted (Treatment A), followed by AB521 tablets fasted (Treatment B), followed by AB521 tablets fed (Treatment C)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>AB521 - Sequence BCA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will sequentially receive Treatment B, followed by Treatment C, then Treatment A</description>
    </arm_group>
    <arm_group>
      <arm_group_label>AB521 - Sequence CAB</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will sequentially receive Treatment C, followed by Treatment A, then Treatment B</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>AB521</intervention_name>
      <description>Administered as specified in the treatment arm</description>
      <arm_group_label>AB521 - Sequence ABC</arm_group_label>
      <arm_group_label>AB521 - Sequence BCA</arm_group_label>
      <arm_group_label>AB521 - Sequence CAB</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key Inclusion Criteria:&#xD;
  &#xD;
            -  Continuous non-smoker who has not used nicotine- and tobacco-containing products for&#xD;
               at least 3 months prior to the first dosing based on volunteer self-reporting&#xD;
  &#xD;
            -  Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilogram (kg)/square meter (m^2) at the&#xD;
               screening visit, with body weight ≥ 45 kg&#xD;
  &#xD;
            -  Medically healthy with no clinically significant medical history, physical&#xD;
               examination, laboratory profiles, vital signs, and ECGs, as deemed by the study&#xD;
               physician&#xD;
  &#xD;
            -  Able to swallow multiple capsules and tablets&#xD;
  &#xD;
            -  Has adequate peripheral venous access&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            -  Has active neoplastic disease or history of neoplastic disease within 5 years of the&#xD;
               screening visit (except for basal or squamous cell carcinoma of the skin or carcinoma&#xD;
               in situ that has been definitively treated with standard of care)&#xD;
  &#xD;
            -  Has abnormal liver enzyme test results or hematology values at the time of enrollment&#xD;
  &#xD;
            -  Has a history of additional risk factors for Torsades de pointes (example: heart&#xD;
               failure, hypokalemia, family history of Long QT Syndrome)&#xD;
  &#xD;
            -  Malabsorption condition that would alter the absorption of orally administered&#xD;
               medications at the discretion of the study physician&#xD;
  &#xD;
            -  Participation in another clinical study within 90 days or within 5 half-lives (if&#xD;
               known), prior to the first dosing, whichever is longer. The 90-day window will be&#xD;
               derived from the date of the last blood collection or dosing, whichever is later, in&#xD;
               the previous study to Day 1 of the current study&#xD;
  &#xD;
          Note: Other protocol defined Inclusion/Exclusion criteria may apply.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Medical Director</last_name>
      <role>Study Director</role>
      <affiliation>Arcus Biosciences</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Medical Director</last_name>
      <phone>+1-510-462-3330</phone>
      <email>ClinicalTrials@arcusbio.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Celerion, Inc.</name>
        <address>
          <city>Lincoln</city>
          <state>Nebraska</state>
          <zip>68502</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>AB521</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.&#xD;
  For more information, please visit our website.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_url>https://trials.arcusbio.com/our-transparency-policy</ipd_url>
    </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/NCT05999513
  org study id: ARC-28
  nct id: NCT05999513
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The primary purpose of this study is to compare the single-dose pharmacokinetics (PK) of
        AB521 tablet versus the AB521 capsule, and to evaluate the effect of food on the single-dose
        PK of AB521 tablet in healthy adult volunteers.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Area Under the Plasma Drug Concentration-Time Curve (AUC)
  time frame: Predose, Up to 168 hours postdose
  measure: Maximum Concentration (Cmax)
  time frame: Predose, Up to 168 hours postdose
  measure: Time to Maximum Concentration (Tmax)
  time frame: Predose, Up to 168 hours postdose
  measure: Terminal Half-Life Time (t1/2)
  time frame: Predose, Up to 168 hours postdose
  measure: Apparent Total Plasma Clearance (CL/F)
  time frame: Predose, Up to 168 hours postdose
  measure: Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)
  time frame: Predose, Up to 168 hours postdose
  measure: Number of Participants With Adverse Events
  time frame: Up to 10 weeks
  arm group label: AB521 - Sequence ABC
  arm group type: Experimental
  description: Participants will sequentially receive AB521 capsules fasted (Treatment A), followed by AB521 tablets fasted (Treatment B), followed by AB521 tablets fed (Treatment C)
  arm group label: AB521 - Sequence BCA
  arm group type: Experimental
  description: Participants will sequentially receive Treatment B, followed by Treatment C, then Treatment A
  arm group label: AB521 - Sequence CAB
  arm group type: Experimental
  description: Participants will sequentially receive Treatment C, followed by Treatment A, then Treatment B
  intervention type: Drug
  intervention name: AB521
  description: Administered as specified in the treatment arm
  arm group label: AB521 - Sequence ABC
  arm group label: AB521 - Sequence BCA
  arm group label: AB521 - Sequence CAB
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Medical Director
  role: Study Director
  affiliation: Arcus Biosciences
  last name: Medical Director
  phone: +1-510-462-3330
  email: ClinicalTrials@arcusbio.com
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
  For more information, please visit our website.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd url: https://trials.arcusbio.com/our-transparency-policy