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

August 1, 2024 updated by: Astex Pharmaceuticals, Inc.

A Phase 1, 3-Way Crossover Study to Evaluate the Effect of Food on Pharmacokinetics of ASTX029

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New Jersey
      • Secaucus, New Jersey, United States, 07094
        • Frontage Clinical Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment A - Fasting
Fasting conditions
Form: tablet; Route of Administration: oral
Experimental: Treatment B - Fed
High-fat/high-calorie breakfast
Form: tablet; Route of Administration: oral
Experimental: Treatment C - Fed
Low-fat/low-calorie breakfast
Form: tablet; Route of Administration: oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic parameter Cmax
Time Frame: Predose to 72 hours postdose, up to Day 4
Maximum plasma concentration
Predose to 72 hours postdose, up to Day 4
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
Predose to 72 hours postdose, up to Day 4
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
Predose to 72 hours postdose, up to Day 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic parameter Tmax
Time Frame: Predose to 72 hours postdose, up to Day 4
Time to reach maximum plasma concentration
Predose to 72 hours postdose, up to Day 4
Pharmacokinetic parameter t1/2
Time Frame: Predose to 72 hours postdose, up to Day 4
Elimination half-life
Predose to 72 hours postdose, up to Day 4
Pharmacokinetic parameter Kel
Time Frame: Predose to 72 hours postdose, up to Day 4
Terminal elimination rate constant
Predose to 72 hours postdose, up to Day 4
Number of participants with Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to Day 42
Up to Day 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Kim-Hien Dao, DO, PhD, Astex Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2020

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

October 6, 2020

Study Registration Dates

First Submitted

July 8, 2020

First Submitted That Met QC Criteria

July 8, 2020

First Posted (Actual)

July 10, 2020

Study Record Updates

Last Update Posted (Actual)

August 2, 2024

Last Update Submitted That Met QC Criteria

August 1, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • ASTX029-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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