Healthy VolunteersPhase 1NCT04466514
A Phase 1 Study to Evaluate the Effect of Food on Pharmacokinetics of ASTX029
A Phase 1 study testing ASTX029 in people with Healthy Volunteers, run by Astex Pharmaceuticals, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ASTX029
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2020to 6 Oct 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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.
- Evidence of renal dysfunction, including estimated glomerular filtration rate ≤60 mL/min.
- 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.
- Participants who have a history of difficulty in donating blood or difficulty with phlebotomy procedures, and poor venous access.
- Participants who have participated in another clinical trial within 30 days prior to the first study period.
- Study staff or first-degree relative of study staff or the Sponsor directly involved in the study.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Frontage Clinical Services
Secaucus, New Jersey, 07094
About this study
Official title: 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.
- Conditions
- Healthy Volunteers
- Being tested
- ASTX029
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASTX029Drug
Form: tablet; Route of Administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Treatment A - Fasting | Experimental | Fasting conditions Receives: Drug: ASTX029 |
| Treatment B - Fed | Experimental | High-fat/high-calorie breakfast Receives: Drug: ASTX029 |
| Treatment C - Fed | Experimental | Low-fat/low-calorie breakfast Receives: Drug: ASTX029 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter Cmax
Maximum plasma concentration
Measured: 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
Measured: Predose to 72 hours postdose, up to Day 4
Pharmacokinetic parameter AUC(0-∞)
Area under the concentration versus time exposures extrapolated to infinity
Measured: Predose to 72 hours postdose, up to Day 4
Secondary outcomes (4)
Pharmacokinetic parameter Tmax
Time to reach maximum plasma concentration
Measured: Predose to 72 hours postdose, up to Day 4
Pharmacokinetic parameter t1/2
Elimination half-life
Measured: Predose to 72 hours postdose, up to Day 4
Pharmacokinetic parameter Kel
Terminal elimination rate constant
Measured: Predose to 72 hours postdose, up to Day 4
Number of participants with Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start23 Jul 2020
- Primary completion1 Oct 2020
- Study completion6 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astex Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466514
- Sponsor's protocol ID
- ASTX029-11
- Status last verified
- Aug 2024
- First submitted
- 8 Jul 2020
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, 3-Way Crossover Study to Evaluate the Effect of Food on Pharmacokinetics of ASTX029
- ClinicalTrials.gov ID
- NCT04466514
- Acronym / sponsor ID
- ASTX029-11
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Astex Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 6 Oct 2020 (actual)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A - Fasting | Experimental | Drug: ASTX029Fasting conditions |
| Treatment B - Fed | Experimental | Drug: ASTX029High-fat/high-calorie breakfast |
| Treatment C - Fed | Experimental | Drug: ASTX029Low-fat/low-calorie breakfast |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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:
- Medically healthy based on medical history, vital sign measurements, clinical laboratory test results, and physical examination.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASTX029Form: tablet; Route of Administration: oral | Drug | Treatment A - Fasting, Treatment B - Fed, Treatment C - Fed |
Primary outcome
Pharmacokinetic parameter Cmax
Time frame: Predose to 72 hours postdose, up to Day 4
Maximum plasma concentration
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
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
4 secondary outcomes
Pharmacokinetic parameter Tmax
Time frame: Predose to 72 hours postdose, up to Day 4
Pharmacokinetic parameter t1/2
Time frame: Predose to 72 hours postdose, up to Day 4
Pharmacokinetic parameter Kel
Time frame: Predose to 72 hours postdose, up to Day 4
Number of participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Day 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
RecruitingPhase 1
A Study of INI-822 in Healthy Volunteers and Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed MASH
Metabolic Dysfunction-Associated Steatohepatitis
Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Healthy Volunteers
Not yet recruitingPhase 1
A Study of Zovaglutide (ZT002 Injection) in Participants With Hepatic Impairment and Healthy Participants
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingObservational study
Visual Attention, Object Recognition, and Eye Movements in Healthy Volunteers
Healthy Volunteer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASTX029 in people with Healthy Volunteers, run by Astex Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic parameter Cmax (time frame: Predose to 72 hours postdose, up to Day 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.