<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/NCT04479800</url>
  </required_header>
  <id_info>
    <org_study_id>ASTX660-11</org_study_id>
    <nct_id>NCT04479800</nct_id>
  </id_info>
  <brief_title>Effect of Food on the Pharmacokinetics of ASTX660 in Healthy Volunteers</brief_title>
  <official_title>A Phase 1, Three-Way Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of ASTX660 in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astex Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Astex Pharmaceuticals, 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>
      This is a Phase 1, single-dose, open-label, randomized, three-period, three-way crossover&#xD;
      study in which healthy adult participants will receive three separate single-dose&#xD;
      administrations of ASTX660 capsules under three different conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants receiving Treatment A (fasting) will be dosed after having fasted overnight for&#xD;
      at least 10 hours. Participants receiving Treatment B (fed; high-fat/high-calorie meal) will&#xD;
      fast overnight for at least 10 hours then consume a Food and Drug Administration (FDA)&#xD;
      standard high-fat, high-calorie breakfast beginning 30 minutes before dosing. Participants&#xD;
      receiving Treatment C (fed; low-fat/low-calorie meal) will fast overnight for at least 10&#xD;
      hours then consume an FDA standard low-fat, low-calorie breakfast beginning 30 minutes before&#xD;
      dosing. The duration of the study is expected to be approximately 47 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Actual">August 25, 2020</completion_date>
  <primary_completion_date type="Actual">August 25, 2020</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetic parameter Cmax</measure>
    <time_frame>Predose to 72 hours postdose, up to Day 4</time_frame>
    <description>Maximum plasma concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameter Tmax</measure>
    <time_frame>Predose to 72 hours postdose, up to Day 4</time_frame>
    <description>Time to reach maximum plasma concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameter λz</measure>
    <time_frame>Predose to 72 hours postdose, up to Day 4</time_frame>
    <description>Observed terminal rate constant</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameter t1/2</measure>
    <time_frame>Predose to 72 hours postdose, up to Day 4</time_frame>
    <description>Observed terminal half-life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameter AUC(0-24h)</measure>
    <time_frame>Predose to 24 hours postdose, up to Day 4</time_frame>
    <description>Area under the concentration-time curve from time-zero to 24 hours postdose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameter AUClast</measure>
    <time_frame>Predose to 72 hours postdose, up to Day 4</time_frame>
    <description>Area under the concentration-time curve from time-zero to the time of the last quantifiable concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameter AUCinf</measure>
    <time_frame>Predose to 72 hours postdose, up to Day 4</time_frame>
    <description>Area under the concentration-time curve from time-zero extrapolated to infinity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameter AUCExtrap (%)</measure>
    <time_frame>Predose to 72 hours postdose, up to Day 4</time_frame>
    <description>Percentage of AUCinf based on extrapolation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameter Clast</measure>
    <time_frame>Predose to 72 hours postdose, up to Day 4</time_frame>
    <description>Last quantifiable concentration determined directly from individual concentration-time data</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameter Tlast</measure>
    <time_frame>Predose to 72 hours postdose, up to Day 4</time_frame>
    <description>Time of the last quantifiable concentration</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Healthy Volunteer</condition>
  <arm_group>
    <arm_group_label>Treatment A - Fasting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>No food prior to dosing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment B - Fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High-fat/high-calorie meal prior to dosing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment C - Fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low-fat/low-calorie meal prior to dosing</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ASTX660</intervention_name>
    <description>Form: capsule; Route of administration: oral</description>
    <arm_group_label>Treatment A - Fasting</arm_group_label>
    <arm_group_label>Treatment B - Fed</arm_group_label>
    <arm_group_label>Treatment C - Fed</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Voluntarily consents to participate in this study and provides written informed&#xD;
             consent before the start of any study-specific procedures.&#xD;
&#xD;
          2. Male or female.&#xD;
&#xD;
          3. Is between 18 and 55 years of age (inclusive).&#xD;
&#xD;
          4. Has a body mass index (BMI) between 18 and 32 kg/m2 (inclusive) and weighs a minimum&#xD;
             of 50 kg.&#xD;
&#xD;
          5. Females must be of non-childbearing potential (defined as surgically sterile [i.e. had&#xD;
             a bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 6 months&#xD;
             before the first dose of study medication] or postmenopausal for at least 1 year&#xD;
             before the first dose of study medication).&#xD;
&#xD;
          6. Is willing and able to remain in the study unit for the entire duration of the&#xD;
             confinement period.&#xD;
&#xD;
          7. Is willing and able to consume the entire FDA standard high-fat and low-fat meal in&#xD;
             the timeframe required during the designated study periods.&#xD;
&#xD;
          8. Has vital signs (measured sitting after a minimum 3 minutes rest) at screening within&#xD;
             the following ranges: heart rate: 40-100 bpm; systolic blood pressure (BP): 90-145&#xD;
             mmHg; diastolic BP: 50-95 mmHg. Out-of-range vital signs may be repeated once at the&#xD;
             Investigator's discretion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History or presence of clinically significant cardiovascular, pulmonary, hepatic,&#xD;
             renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic,&#xD;
             neurologic, oncologic, autoimmune, or psychiatric disease or any other condition that,&#xD;
             in the opinion of the Investigator, would jeopardize the safety of the participant or&#xD;
             the validity of the study results.&#xD;
&#xD;
          2. A clinically significant abnormal finding on the physical exam, medical history,&#xD;
             electrocardiogram (ECG), or clinical laboratory results at screening.&#xD;
&#xD;
          3. Has laboratory values that are not within normal limits for amylase and lipase,&#xD;
             phosphorus, alkaline phosphatase (ALP), aspartate transaminase (AST), alanine&#xD;
             transaminase (ALT), bilirubin, white blood cell count (WBC) and absolute neutrophil&#xD;
             count (ANC), international normalized ratio (INR), C-reactive protein (CRP), or has&#xD;
             any other clinically significant abnormal chemistry values in the opinion of the&#xD;
             Investigator.&#xD;
&#xD;
          4. Has an ECG parameter (confirmed by repeat evaluation) of PR ≥ 200 ms, or QRS ≥ 110 ms,&#xD;
             or QT interval corrected by the method of Fridericia (QTcF) &gt; 450 ms at screening&#xD;
             visit.&#xD;
&#xD;
          5. History or presence of allergic or adverse response to ASTX660 or related drugs or&#xD;
             ASTX660 excipients.&#xD;
&#xD;
          6. Has been on a significantly abnormal diet (i.e., low-calorie, vegan, or intermittent&#xD;
             fasting) during the 4 weeks preceding the first dose of study medication.&#xD;
&#xD;
          7. Has participated in another clinical trial (randomized participants only) within 30&#xD;
             days before the first dose of study medication.&#xD;
&#xD;
          8. Use of any over-the-counter (OTC) medication (including nutritional or dietary&#xD;
             supplements, herbal preparations, or vitamins) within 7 days before the first dose of&#xD;
             study medication until the end of study visit without evaluation and approval by the&#xD;
             Investigator.&#xD;
&#xD;
          9. Use of any prescription medication, except hormonal replacement therapy, from 14 days&#xD;
             before the first dose of study medication until the end-of-study visit without&#xD;
             evaluation and approval by the Investigator.&#xD;
&#xD;
         10. Has been treated with any known drugs that are moderate or strong inhibitors/inducers&#xD;
             of cytochrome P450 (CYP) enzymes (e.g., barbiturates, phenothiazines, cimetidine,&#xD;
             carbamazepine) or known P-gp inhibitors, or is taking any concomitant medication&#xD;
             within 30 days before the first dose of study medication.&#xD;
&#xD;
         11. Blood or plasma donation within 30 days before the first dose of study medication&#xD;
             until the end-of-study visit. It is recommended that blood/plasma donations not be&#xD;
             made for at least 30 days after the end-of-study visit.&#xD;
&#xD;
         12. Smoking or use of tobacco- or nicotine-containing products within 60 days before the&#xD;
             first dose of study medication until the end-of-study visit.&#xD;
&#xD;
         13. Engagement in strenuous exercise from 48 hours before the first dose of study&#xD;
             medication until the end-of-study visit.&#xD;
&#xD;
         14. Consumption of beverages or foods that contain alcohol, grapefruit, poppy seeds,&#xD;
             broccoli, Brussels sprouts, pomegranate, star fruit, char-grilled meat, or&#xD;
             caffeine/xanthine from 48 hours before the first dose of study medication until the&#xD;
             end-of-study visit. Participants will be instructed not to consume any of the above&#xD;
             products; however, allowance for an isolated single incidental consumption may be&#xD;
             evaluated and approved by the study Investigator based on the potential for&#xD;
             interaction with the study drug.&#xD;
&#xD;
         15. Has any prior history of substance abuse or treatment (including alcohol).&#xD;
&#xD;
         16. Is a female with a positive pregnancy test result.&#xD;
&#xD;
         17. Has a positive urine screen for drugs of abuse (amphetamines, barbiturates,&#xD;
             benzodiazepines, cocaine, cannabinoids, opiates) or cotinine.&#xD;
&#xD;
         18. Has a positive test for hepatitis B surface antigen, hepatitis C antibody, or human&#xD;
             immunodeficiency virus (HIV) at screening or has been previously treated for hepatitis&#xD;
             B, hepatitis C, or HIV infection.&#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>Harold Keer, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Astex Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Worldwide Clinical Trials</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>September 14, 2020</last_update_submitted>
  <last_update_submitted_qc>September 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2020</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/NCT04479800
org study id: ASTX660-11
nct id: NCT04479800
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 1, single-dose, open-label, randomized, three-period, three-way crossover
      study in which healthy adult participants will receive three separate single-dose
      administrations of ASTX660 capsules under three different conditions.
Participants receiving Treatment A (fasting) will be dosed after having fasted overnight for
      at least 10 hours. Participants receiving Treatment B (fed; high-fat/high-calorie meal) will
      fast overnight for at least 10 hours then consume a Food and Drug Administration (FDA)
      standard high-fat, high-calorie breakfast beginning 30 minutes before dosing. Participants
      receiving Treatment C (fed; low-fat/low-calorie meal) will fast overnight for at least 10
      hours then consume an FDA standard low-fat, low-calorie breakfast beginning 30 minutes before
      dosing. The duration of the study is expected to be approximately 47 days.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Pharmacokinetic parameter Cmax
time frame: Predose to 72 hours postdose, up to Day 4
description: Maximum plasma concentration
measure: Pharmacokinetic parameter Tmax
time frame: Predose to 72 hours postdose, up to Day 4
description: Time to reach maximum plasma concentration
measure: Pharmacokinetic parameter λz
time frame: Predose to 72 hours postdose, up to Day 4
description: Observed terminal rate constant
measure: Pharmacokinetic parameter t1/2
time frame: Predose to 72 hours postdose, up to Day 4
description: Observed terminal half-life
measure: Pharmacokinetic parameter AUC(0-24h)
time frame: Predose to 24 hours postdose, up to Day 4
description: Area under the concentration-time curve from time-zero to 24 hours postdose
measure: Pharmacokinetic parameter AUClast
time frame: Predose to 72 hours postdose, up to Day 4
description: Area under the concentration-time curve from time-zero to the time of the last quantifiable concentration
measure: Pharmacokinetic parameter AUCinf
time frame: Predose to 72 hours postdose, up to Day 4
description: Area under the concentration-time curve from time-zero extrapolated to infinity
measure: Pharmacokinetic parameter AUCExtrap (%)
time frame: Predose to 72 hours postdose, up to Day 4
description: Percentage of AUCinf based on extrapolation
measure: Pharmacokinetic parameter Clast
time frame: Predose to 72 hours postdose, up to Day 4
description: Last quantifiable concentration determined directly from individual concentration-time data
measure: Pharmacokinetic parameter Tlast
time frame: Predose to 72 hours postdose, up to Day 4
description: Time of the last quantifiable concentration
arm group label: Treatment A - Fasting
arm group type: Experimental
description: No food prior to dosing
arm group label: Treatment B - Fed
arm group type: Experimental
description: High-fat/high-calorie meal prior to dosing
arm group label: Treatment C - Fed
arm group type: Experimental
description: Low-fat/low-calorie meal prior to dosing
intervention type: Drug
intervention name: ASTX660
description: Form: capsule; Route of administration: oral
arm group label: Treatment A - Fasting
arm group label: Treatment B - Fed
arm group label: Treatment C - Fed
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Harold Keer, MD, PhD
role: Study Director
affiliation: Astex Pharmaceuticals, Inc.
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No