<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/NCT04466514</url>
  </required_header>
  <id_info>
    <org_study_id>ASTX029-11</org_study_id>
    <nct_id>NCT04466514</nct_id>
  </id_info>
  <brief_title>A Phase 1 Study to Evaluate the Effect of Food on Pharmacokinetics of ASTX029</brief_title>
  <official_title>A Phase 1, 3-Way Crossover Study to Evaluate the Effect of Food on Pharmacokinetics of ASTX029</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>
      Open-label, single dose, randomized, three-period, crossover design study to evaluate the&#xD;
      effect of food on the bioavailability of a single oral dose of ASTX029 in healthy adult male&#xD;
      and female participants.&#xD;
&#xD;
      Following a screening period of up to 28 days, eligible participants will be enrolled and&#xD;
      randomized to receive a single treatment (A, B, C) in a random order, with each treatment&#xD;
      separated by an approximate 5-day washout period. The duration of the study is expected to be&#xD;
      approximately 42 days.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 23, 2020</start_date>
  <completion_date type="Actual">October 6, 2020</completion_date>
  <primary_completion_date type="Actual">October 1, 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 AUC(0-t)</measure>
    <time_frame>Predose to 72 hours postdose, up to Day 4</time_frame>
    <description>Area under the concentration versus time exposures calculated to the last measurable observation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameter AUC(0-∞)</measure>
    <time_frame>Predose to 72 hours postdose, up to Day 4</time_frame>
    <description>Area under the concentration versus time exposures extrapolated to infinity</description>
  </primary_outcome>
  <secondary_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>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameter t1/2</measure>
    <time_frame>Predose to 72 hours postdose, up to Day 4</time_frame>
    <description>Elimination half-life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameter Kel</measure>
    <time_frame>Predose to 72 hours postdose, up to Day 4</time_frame>
    <description>Terminal elimination rate constant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Treatment-Emergent Adverse Events (TEAEs)</measure>
    <time_frame>Up to Day 42</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Treatment A - Fasting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fasting conditions</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 breakfast</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 breakfast</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ASTX029</intervention_name>
    <description>Form: tablet; 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. Capable of giving informed consent and complying with study procedures.&#xD;
&#xD;
          2. Male or female, 18 to 45 years of age, inclusive, at date of consent.&#xD;
&#xD;
          3. Body mass index (BMI) ≥ 18.0 to ≤ 32.0 kg/m2 and total body weight &gt; 50 kg (110 lbs.)&#xD;
             at Screening.&#xD;
&#xD;
          4. All female participants must have a negative pregnancy test at Screening and at each&#xD;
             Check-in Visit; and one of the following:&#xD;
&#xD;
               1. Using a medically acceptable form of birth control for at least 1 month prior to&#xD;
                  first dose [e.g., hormonal contraceptives (oral, patch, injectable or vaginal&#xD;
                  ring), intrauterine device, or a double barrier method (e.g., diaphragm, cervical&#xD;
                  cap, oral, patch or vaginal hormonal contraceptive, condom, spermicide, or&#xD;
                  sponge)];&#xD;
&#xD;
               2. Documented as surgically sterile by hysterectomy, bilateral oophorectomy,&#xD;
                  bilateral salpingectomy, or bilateral tubal ligation/tubal occlusion) at least 6&#xD;
                  months prior to the first dose;&#xD;
&#xD;
               3. Postmenopausal (no menstruation for a minimum of 12 months and confirmed by&#xD;
                  follicle stimulating hormone (FSH) and estradiol at Screening).&#xD;
&#xD;
          5. Medically healthy based on medical history, vital sign measurements, clinical&#xD;
             laboratory test results, and physical examination.&#xD;
&#xD;
          6. Non-smokers (including nicotine-containing products) for at least 6 continuous months&#xD;
             prior to the first dose.&#xD;
&#xD;
          7. Be willing and able to consume all contents of the standardized breakfast (high-fat&#xD;
             and low-fat) within 30 minutes prior to dosing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Females who are pregnant, lactating, or planning to become pregnant during the study.&#xD;
&#xD;
          2. Reported life-time history and/or recent evidence of alcohol or drug/substance abuse&#xD;
             disorder.&#xD;
&#xD;
          3. Participants with reported history of hypersensitivity to ASTX029, or any component of&#xD;
             the study drug formulation.&#xD;
&#xD;
          4. Participants who suffer from clinically significant systemic allergic disease or have&#xD;
             a reported history of significant drug allergies, including, but not limited to, a&#xD;
             history of anaphylactic reactions, or allergic reactions due to any drug leading to&#xD;
             significant morbidity.&#xD;
&#xD;
          5. Participants who test positive at Screening for human immunodeficiency virus (HIV),&#xD;
             Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibody.&#xD;
&#xD;
          6. Participants who test positive at Screening or at Check-in for alcohol and/or drugs of&#xD;
             abuse.&#xD;
&#xD;
          7. Participants who donated ≥ 500 mL of blood within 56 days prior to the first dose of&#xD;
             study drug or ≥ 50 mL and ≤ 499 mL of blood within 30 days or plasma (e.g.&#xD;
             plasmapheresis) within 14 days prior to the first dose of study drug.&#xD;
&#xD;
          8. Screening 12-lead ECG with measurable QTc interval of ≥430 msec for males, ≥440 msec&#xD;
             for females;&#xD;
&#xD;
          9. Reported history or current evidence/risk of retinal vein occlusion (RVO) or central&#xD;
             serous retinopathy (CSR) including:&#xD;
&#xD;
               1. Presence or history of predisposing factors to RVO or CSR (e.g., glaucoma or&#xD;
                  ocular hypertension, diabetes mellitus) or,&#xD;
&#xD;
               2. Visible retinal pathology as assessed by examination at screening that is&#xD;
                  considered a risk factor for RVO or CSR such as:&#xD;
&#xD;
               3. Evidence of optic disc cupping or,&#xD;
&#xD;
               4. Evidence of new visual field defects on automated perimetry.&#xD;
&#xD;
         10. Reported history of glaucoma or presence of any retinal diseases, including but not&#xD;
             limited to, floaters, retinal detachment, macular degeneration, diabetic eye disease,&#xD;
             retinitis pigmentosa.&#xD;
&#xD;
         11. Reported history or presence of hepatitis and/or hepatic dysfunction, based on subject&#xD;
             medical history and clinical laboratory test results.&#xD;
&#xD;
         12. Evidence of renal dysfunction, including estimated glomerular filtration rate ≤60&#xD;
             mL/min.&#xD;
&#xD;
         13. Use of prescription or non-prescription drugs, dietary supplements, or herbal&#xD;
             supplements at the time of Screening and within 14 days prior to the first dose of the&#xD;
             study drug.&#xD;
&#xD;
         14. Participants who have a history of difficulty in donating blood or difficulty with&#xD;
             phlebotomy procedures, and poor venous access.&#xD;
&#xD;
         15. Participants who have participated in another clinical trial within 30 days prior to&#xD;
             the first study period.&#xD;
&#xD;
         16. Study staff or first-degree relative of study staff or the Sponsor directly involved&#xD;
             in the study.&#xD;
&#xD;
         17. Any condition which in the opinion of Investigator would interfere with the subject's&#xD;
             ability to provide informed consent, comply with study instructions, confound&#xD;
             interpretation of study results, or endanger the subject if he or she took part in the&#xD;
             trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kim-Hien Dao, DO, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Astex Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Frontage Clinical Services</name>
      <address>
        <city>Secaucus</city>
        <state>New Jersey</state>
        <zip>07094</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>November 30, 2020</last_update_submitted>
  <last_update_submitted_qc>November 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 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/NCT04466514
org study id: ASTX029-11
nct id: NCT04466514
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Open-label, single dose, randomized, three-period, crossover design study to evaluate the
      effect of food on the bioavailability of a single oral dose of ASTX029 in healthy adult male
      and female participants.

      Following a screening period of up to 28 days, eligible participants will be enrolled and
      randomized to receive a single treatment (A, B, C) in a random order, with each treatment
      separated by an approximate 5-day washout period. The duration of the study is expected to be
      approximately 42 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 AUC(0-t)
time frame: Predose to 72 hours postdose, up to Day 4
description: Area under the concentration versus time exposures calculated to the last measurable observation
measure: Pharmacokinetic parameter AUC(0-∞)
time frame: Predose to 72 hours postdose, up to Day 4
description: Area under the concentration versus time exposures extrapolated to infinity
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 t1/2
time frame: Predose to 72 hours postdose, up to Day 4
description: Elimination half-life
measure: Pharmacokinetic parameter Kel
time frame: Predose to 72 hours postdose, up to Day 4
description: Terminal elimination rate constant
measure: Number of participants with Treatment-Emergent Adverse Events (TEAEs)
time frame: Up to Day 42
arm group label: Treatment A - Fasting
arm group type: Experimental
description: Fasting conditions
arm group label: Treatment B - Fed
arm group type: Experimental
description: High-fat/high-calorie breakfast
arm group label: Treatment C - Fed
arm group type: Experimental
description: Low-fat/low-calorie breakfast
intervention type: Drug
intervention name: ASTX029
description: Form: tablet; 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: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kim-Hien Dao, DO, PhD
role: Study Director
affiliation: Astex Pharmaceuticals, Inc.
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No