<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/NCT03237988</url>
  </required_header>
  <id_info>
    <org_study_id>CPI-444-002</org_study_id>
    <nct_id>NCT03237988</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Pharmacokinetics of a New Tablet Formulation of CPI-444 in Fed and Fasted Healthy Male and Female Subjects</brief_title>
  <official_title>A Phase 1, Open-label, Randomized, Single-dose, Three-way Crossover Study to Evaluate the Pharmacokinetics of a New Tablet Formulation of CPI-444 in Fed and Fasted Healthy Male and Female Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corvus Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Corvus Pharmaceuticals, 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 will be a Phase 1, open-label, randomized, 3-way crossover study to evaluate PK, safety,&#xD;
      and tolerability of a new tablet formulation of CPI-444 and to evaluate the effect of food on&#xD;
      single oral doses of CPI-444 tablets in healthy male and female subjects. Potential subjects&#xD;
      will be screened to assess their eligibility to enter the study within 28 days prior to the&#xD;
      first dose administration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2017</start_date>
  <completion_date type="Actual">October 4, 2017</completion_date>
  <primary_completion_date type="Actual">September 20, 2017</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUC0-∞: AUC from time zero to infinity</measure>
    <time_frame>Predose through 72 hours postdose</time_frame>
    <description>Area under the plasma concentration-time curve (AUC) from time zero to infinity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-tz: AUC from time zero to last quantifiable concentration</measure>
    <time_frame>Predose through 72 hours postdose</time_frame>
    <description>AUC from time zero to the last quantifiable concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>%AUCex: Percentage of AUC0-∞ that was due to extrapolation from the last quantifiable concentration to infinity</measure>
    <time_frame>Predose through 72 hours postdose</time_frame>
    <description>Percentage of AUC0-∞ that was due to extrapolation from the last quantifiable concentration to infinity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence and severity of adverse events</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>Sequence ABC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100 mg CPI-444, given orally as a 1 × 100-mg capsule, after an overnight fast of at least 10 hours (fasted); 100 mg CPI-444, given orally as a 1 × 100-mg tablet, after an overnight fast of at least 10 hours (fasted); 100 mg CPI-444, given orally as a 1 × 100-mg tablet, 30 minutes after the start of a high-fat breakfast (fed).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence BCA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100 mg CPI-444, given orally as a 1 × 100-mg tablet, after an overnight fast of at least 10 hours (fasted); 100 mg CPI-444, given orally as a 1 × 100-mg tablet, 30 minutes after the start of a high-fat breakfast (fed); 100 mg CPI-444, given orally as a 1 × 100-mg capsule, after an overnight fast of at least 10 hours (fasted).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence CAB</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100 mg CPI-444, given orally as a 1 × 100-mg tablet, 30 minutes after the start of a high-fat breakfast (fed); 100 mg CPI-444, given orally as a 1 × 100-mg capsule, after an overnight fast of at least 10 hours (fasted); 100 mg CPI-444, given orally as a 1 × 100-mg tablet, after an overnight fast of at least 10 hours (fasted).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CPI-444 Capsules</intervention_name>
    <description>100mg Capsule</description>
    <arm_group_label>Sequence ABC</arm_group_label>
    <arm_group_label>Sequence BCA</arm_group_label>
    <arm_group_label>Sequence CAB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CPI-444 Tablets</intervention_name>
    <description>100mg Tablets</description>
    <arm_group_label>Sequence ABC</arm_group_label>
    <arm_group_label>Sequence BCA</arm_group_label>
    <arm_group_label>Sequence CAB</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males or females, of any race, 18 to 65 years of age, inclusive, at Screening.&#xD;
&#xD;
          2. Body mass index between 18.5 and 32.0 kg/m2, inclusive, at Screening.&#xD;
&#xD;
          3. In good health.&#xD;
&#xD;
          4. Females will be nonpregnant and nonlactating, and females of childbearing potential&#xD;
             and males will agree to use contraception.&#xD;
&#xD;
          5. Able to comprehend and willing to sign an Informed Consent Form (ICF) and to abide by&#xD;
             the study restrictions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Significant history or clinical manifestation of any metabolic, allergic,&#xD;
             dermatological, hepatic, renal, hematological, pulmonary, cardiovascular,&#xD;
             gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder.&#xD;
&#xD;
          2. Subjects who have received any IMP in a clinical research study within 5 half-lives or&#xD;
             within 30 days prior to first dose.&#xD;
&#xD;
          3. Females of childbearing potential who are pregnant or lactating. Females of&#xD;
             non-childbearing potential are defined as permanently sterile or postmenopausal.&#xD;
             Postmenopausal status will be confirmed with a screening serum follicle-stimulating&#xD;
             hormone (FSH) level greater than 40 mIU/mL.&#xD;
&#xD;
          4. A history or evidence of clinically significant gastrointestinal disease, including&#xD;
             ulcers, gastro-esophageal reflux disease, or gastritis.&#xD;
&#xD;
          5. A history of alcoholism or drug/chemical abuse within 2 years prior to Period 1&#xD;
             Check-in.&#xD;
&#xD;
          6. Regular alcohol consumption of &gt;21 units per week for males and &gt;14 units for females.&#xD;
             One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL)&#xD;
             wine.&#xD;
&#xD;
          7. Positive urine drug screen (confirmed by repeat) at Screening (does not include&#xD;
             alcohol) or Check-in (does include alcohol).&#xD;
&#xD;
          8. Use of prescription or nonprescription drugs, including vitamins, herbal, and dietary&#xD;
             supplements (ie, St John's wort) within 7 days (or 14 days if the drug is a potential&#xD;
             enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of IMP.&#xD;
&#xD;
          9. Use of tobacco, smoking cessation products, or products containing nicotine&#xD;
             (including, but not limited to, cigarettes, e-cigarettes, pipes, cigars, chewing&#xD;
             tobacco, nicotine lozenges, or nicotine gum) within 6 months prior to Period 1&#xD;
             Check-in until Discharge from the CRU following the final dose.&#xD;
&#xD;
         10. Consumption of foods and beverages containing poppy seeds, grapefruit, or Seville&#xD;
             oranges will not be allowed from 7 days prior to Period 1 Check-in until Discharge&#xD;
             from the CRU following the final dose.&#xD;
&#xD;
         11. Consumption of caffeine-containing foods and beverages will not be allowed from 72&#xD;
             hours prior to Check-in until Discharge on Day 4 of each treatment period.&#xD;
&#xD;
         12. Poor peripheral venous access.&#xD;
&#xD;
         13. Evidence of renal impairment at Screening, as indicated by an estimated creatinine&#xD;
             clearance of less than 80 mL/min using the Cockcroft-Gault equation.&#xD;
&#xD;
         14. Screening chemistry laboratory values as follows: gamma-glutamyltransferase, aspartate&#xD;
             aminotransferase, and ALT &gt;1.5 × institutional upper limit of normal (ULN), total&#xD;
             bilirubin &gt;1.5 × institutional ULN.&#xD;
&#xD;
         15. A history of seizures (not including simple febrile seizures in childhood);&#xD;
&#xD;
         16. Multiple drug allergies or allergies to any of the components of CPI-444 tablets or&#xD;
             CPI 444 resinate capsules.&#xD;
&#xD;
         17. Known history of human immunodeficiency virus or active infection requiring therapy,&#xD;
             or positive tests for hepatitis B surface antigen or hepatitis C antibody.&#xD;
&#xD;
         18. Any vaccination against infectious diseases (ie, influenza, varicella) within 28 days&#xD;
             of first dose.&#xD;
&#xD;
         19. Donation or loss of greater than 400 mL of blood from 2 months prior to Screening,&#xD;
             donation of platelets from 6 weeks prior to Screening, or plasma from 2 weeks prior to&#xD;
             Screening through the Follow-up phone call.&#xD;
&#xD;
         20. Receipt of blood products within 2 months prior to Period 1 Check-in.&#xD;
&#xD;
         21. Subjects who, in the opinion of the Investigator (or designee), should not participate&#xD;
             in this study.&#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>Covance Clinical Research Unit</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>January 2018</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>January 24, 2018</last_update_submitted>
  <last_update_submitted_qc>January 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03237988
org study id: CPI-444-002
nct id: NCT03237988
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This will be a Phase 1, open-label, randomized, 3-way crossover study to evaluate PK, safety,
      and tolerability of a new tablet formulation of CPI-444 and to evaluate the effect of food on
      single oral doses of CPI-444 tablets in healthy male and female subjects. Potential subjects
      will be screened to assess their eligibility to enter the study within 28 days prior to the
      first dose administration.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: AUC0-∞: AUC from time zero to infinity
time frame: Predose through 72 hours postdose
description: Area under the plasma concentration-time curve (AUC) from time zero to infinity
measure: AUC0-tz: AUC from time zero to last quantifiable concentration
time frame: Predose through 72 hours postdose
description: AUC from time zero to the last quantifiable concentration
measure: %AUCex: Percentage of AUC0-∞ that was due to extrapolation from the last quantifiable concentration to infinity
time frame: Predose through 72 hours postdose
description: Percentage of AUC0-∞ that was due to extrapolation from the last quantifiable concentration to infinity
measure: Incidence and severity of adverse events
time frame: 4 weeks
arm group label: Sequence ABC
arm group type: Active Comparator
description: 100 mg CPI-444, given orally as a 1 × 100-mg capsule, after an overnight fast of at least 10 hours (fasted); 100 mg CPI-444, given orally as a 1 × 100-mg tablet, after an overnight fast of at least 10 hours (fasted); 100 mg CPI-444, given orally as a 1 × 100-mg tablet, 30 minutes after the start of a high-fat breakfast (fed).
arm group label: Sequence BCA
arm group type: Active Comparator
description: 100 mg CPI-444, given orally as a 1 × 100-mg tablet, after an overnight fast of at least 10 hours (fasted); 100 mg CPI-444, given orally as a 1 × 100-mg tablet, 30 minutes after the start of a high-fat breakfast (fed); 100 mg CPI-444, given orally as a 1 × 100-mg capsule, after an overnight fast of at least 10 hours (fasted).
arm group label: Sequence CAB
arm group type: Active Comparator
description: 100 mg CPI-444, given orally as a 1 × 100-mg tablet, 30 minutes after the start of a high-fat breakfast (fed); 100 mg CPI-444, given orally as a 1 × 100-mg capsule, after an overnight fast of at least 10 hours (fasted); 100 mg CPI-444, given orally as a 1 × 100-mg tablet, after an overnight fast of at least 10 hours (fasted).
intervention type: Drug
intervention name: CPI-444 Capsules
description: 100mg Capsule
arm group label: Sequence ABC
arm group label: Sequence BCA
arm group label: Sequence CAB
intervention type: Drug
intervention name: CPI-444 Tablets
description: 100mg Tablets
arm group label: Sequence ABC
arm group label: Sequence BCA
arm group label: Sequence CAB
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No