Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 1 Study to Evaluate the Effect of Food on Pharmacokinetics of ASTX029

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04466514
Recruitment Status : Not yet recruiting
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Astex Pharmaceuticals, Inc.

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: ASTX029 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1, 3-Way Crossover Study to Evaluate the Effect of Food on Pharmacokinetics of ASTX029
Estimated Study Start Date : July 23, 2020
Estimated Primary Completion Date : September 3, 2020
Estimated Study Completion Date : September 3, 2020

Arm Intervention/treatment
Experimental: Treatment A - Fasting
Fasting conditions
Drug: ASTX029
Form: tablet; Route of Administration: oral

Experimental: Treatment B - Fed
High-fat/high-calorie breakfast
Drug: ASTX029
Form: tablet; Route of Administration: oral

Experimental: Treatment C - Fed
Low-fat/low-calorie breakfast
Drug: ASTX029
Form: tablet; Route of Administration: oral




Primary Outcome Measures :
  1. Pharmacokinetic parameter Cmax [ Time Frame: Predose to 72 hours postdose, up to Day 4 ]
    Maximum plasma concentration

  2. Pharmacokinetic parameter AUC(0-t) [ Time Frame: Predose to 72 hours postdose, up to Day 4 ]
    Area under the concentration versus time exposures calculated to the last measurable observation

  3. Pharmacokinetic parameter AUC(0-∞) [ Time Frame: Predose to 72 hours postdose, up to Day 4 ]
    Area under the concentration versus time exposures extrapolated to infinity


Secondary Outcome Measures :
  1. Pharmacokinetic parameter Tmax [ Time Frame: Predose to 72 hours postdose, up to Day 4 ]
    Time to reach maximum plasma concentration

  2. Pharmacokinetic parameter t1/2 [ Time Frame: Predose to 72 hours postdose, up to Day 4 ]
    Elimination half-life

  3. Pharmacokinetic parameter Kel [ Time Frame: Predose to 72 hours postdose, up to Day 4 ]
    Terminal elimination rate constant

  4. Number of participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to Day 42 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Capable of giving informed consent and complying with study procedures.
  2. Male or female, 18 to 45 years of age, inclusive, at date of consent.
  3. Body mass index (BMI) ≥ 18.0 to ≤ 32.0 kg/m2 and total body weight > 50 kg (110 lbs.) at Screening.
  4. All female participants must have a negative pregnancy test at Screening and at each Check-in Visit; and one of the following:

    1. Using a medically acceptable form of birth control for at least 1 month prior to first dose [e.g., hormonal contraceptives (oral, patch, injectable or vaginal ring), intrauterine device, or a double barrier method (e.g., diaphragm, cervical cap, oral, patch or vaginal hormonal contraceptive, condom, spermicide, or sponge)];
    2. Documented as surgically sterile by hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/tubal occlusion) at least 6 months prior to the first dose;
    3. Postmenopausal (no menstruation for a minimum of 12 months and confirmed by follicle stimulating hormone (FSH) and estradiol at Screening).
  5. Medically healthy based on medical history, vital sign measurements, clinical laboratory test results, and physical examination.
  6. Non-smokers (including nicotine-containing products) for at least 6 continuous months prior to the first dose.
  7. Be willing and able to consume all contents of the standardized breakfast (high-fat and low-fat) within 30 minutes prior to dosing.

Exclusion Criteria:

  1. Females who are pregnant, lactating, or planning to become pregnant during the study.
  2. Reported life-time history and/or recent evidence of alcohol or drug/substance abuse disorder.
  3. Participants with reported history of hypersensitivity to ASTX029, or any component of the study drug formulation.
  4. Participants who suffer from clinically significant systemic allergic disease or have a reported history of significant drug allergies, including, but not limited to, a history of anaphylactic reactions, or allergic reactions due to any drug leading to significant morbidity.
  5. Participants who test positive at Screening for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibody.
  6. Participants who test positive at Screening or at Check-in for alcohol and/or drugs of abuse.
  7. Participants who donated ≥ 500 mL of blood within 56 days prior to the first dose of study drug or ≥ 50 mL and ≤ 499 mL of blood within 30 days or plasma (e.g. plasmapheresis) within 14 days prior to the first dose of study drug.
  8. Screening 12-lead ECG with measurable QTc interval of ≥430 msec for males, ≥440 msec for females;
  9. Reported history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR) including:

    1. Presence or history of predisposing factors to RVO or CSR (e.g., glaucoma or ocular hypertension, diabetes mellitus) or,
    2. Visible retinal pathology as assessed by examination at screening that is considered a risk factor for RVO or CSR such as:
    3. Evidence of optic disc cupping or,
    4. Evidence of new visual field defects on automated perimetry.
  10. Reported history of glaucoma or presence of any retinal diseases, including but not limited to, floaters, retinal detachment, macular degeneration, diabetic eye disease, retinitis pigmentosa.
  11. Reported history or presence of hepatitis and/or hepatic dysfunction, based on subject medical history and clinical laboratory test results.
  12. Evidence of renal dysfunction, including estimated glomerular filtration rate ≤60 mL/min.
  13. Use of prescription or non-prescription drugs, dietary supplements, or herbal supplements at the time of Screening and within 14 days prior to the first dose of the study drug.
  14. Participants who have a history of difficulty in donating blood or difficulty with phlebotomy procedures, and poor venous access.
  15. Participants who have participated in another clinical trial within 30 days prior to the first study period.
  16. Study staff or first-degree relative of study staff or the Sponsor directly involved in the study.
  17. Any condition which in the opinion of Investigator would interfere with the subject's ability to provide informed consent, comply with study instructions, confound interpretation of study results, or endanger the subject if he or she took part in the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04466514


Contacts
Layout table for location contacts
Contact: Michelle Fung 925-560-0100 Michelle.Fung@astx.com

Sponsors and Collaborators
Astex Pharmaceuticals, Inc.
Investigators
Layout table for investigator information
Study Director: Kim-Hien Dao, DO, PhD Astex Pharmaceuticals, Inc.
Layout table for additonal information
Responsible Party: Astex Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04466514    
Other Study ID Numbers: ASTX029-11
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No