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

NCT04466514 | Completed Phase 1 FDA Drug

• 1 other identifier: ASTX029-11
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic parameter Cmax

  Maximum plasma concentration

  Predose to 72 hours postdose, up to Day 4

• Pharmacokinetic parameter AUC(0-t)

  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-∞)

  Area under the concentration versus time exposures extrapolated to infinity

  Predose to 72 hours postdose, up to Day 4

Secondary Outcomes (4)

• Pharmacokinetic parameter Tmax

  Predose to 72 hours postdose, up to Day 4

• Pharmacokinetic parameter t1/2

  Predose to 72 hours postdose, up to Day 4

• Pharmacokinetic parameter Kel

  Predose to 72 hours postdose, up to Day 4

• Number of participants with Treatment-Emergent Adverse Events (TEAEs)

  Up to Day 42

Study Arms (3)

Treatment A - Fasting

EXPERIMENTAL

Fasting conditions

Drug: ASTX029

Treatment B - Fed

EXPERIMENTAL

High-fat/high-calorie breakfast

Drug: ASTX029

Treatment C - Fed

EXPERIMENTAL

Low-fat/low-calorie breakfast

Drug: ASTX029

Interventions

ASTX029 DRUG

Form: tablet; Route of Administration: oral

Treatment A - Fasting; Treatment B - Fed; Treatment C - Fed

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Capable of giving informed consent and complying with study procedures.
• Male or female, 18 to 45 years of age, inclusive, at date of consent.
• Body mass index (BMI) ≥ 18.0 to ≤ 32.0 kg/m2 and total body weight \> 50 kg (110 lbs.) at Screening.
• All female participants must have a negative pregnancy test at Screening and at each Check-in Visit; and one of the following:
• Using a medically acceptable form of birth control for at least 1 month prior to first dose \[e.g., hormonal contraceptives (oral, patch, injectable or vaginal ring), intrauterine device, or a double barrier method (e.g., diaphragm, cervical cap, oral, patch or vaginal hormonal contraceptive, condom, spermicide, or sponge)\];
• 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;
• Postmenopausal (no menstruation for a minimum of 12 months and confirmed by follicle stimulating hormone (FSH) and estradiol at Screening).
• Medically healthy based on medical history, vital sign measurements, clinical laboratory test results, and physical examination.
• Non-smokers (including nicotine-containing products) for at least 6 continuous months prior to the first dose.
• Be willing and able to consume all contents of the standardized breakfast (high-fat and low-fat) within 30 minutes prior to dosing.

You may not qualify if:

• Females who are pregnant, lactating, or planning to become pregnant during the study.
• Reported life-time history and/or recent evidence of alcohol or drug/substance abuse disorder.
• Participants with reported history of hypersensitivity to ASTX029, or any component of the study drug formulation.
• 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.
• Participants who test positive at Screening for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibody.
• Participants who test positive at Screening or at Check-in for alcohol and/or drugs of abuse.
• 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.
• Screening 12-lead ECG with measurable QTc interval of ≥430 msec for males, ≥440 msec for females;
• Reported history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR) including:
• Presence or history of predisposing factors to RVO or CSR (e.g., glaucoma or ocular hypertension, diabetes mellitus) or,
• Visible retinal pathology as assessed by examination at screening that is considered a risk factor for RVO or CSR such as:
• Evidence of optic disc cupping or,
• Evidence of new visual field defects on automated perimetry.
• 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.
• Reported history or presence of hepatitis and/or hepatic dysfunction, based on subject medical history and clinical laboratory test results.

Sponsors & Collaborators

• Astex Pharmaceuticals, Inc.: lead

Study Sites (1)

Frontage Clinical Services

Secaucus, New Jersey, 07094, United States

Location

MeSH Terms

Interventions

ASTX029

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 10, 2020
• Study Start: July 23, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 6, 2020
• Last Updated: August 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)