- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04479800
Effect of Food on the Pharmacokinetics of ASTX660 in Healthy Volunteers
September 14, 2020 updated by: Astex Pharmaceuticals, Inc.
A Phase 1, Three-Way Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of ASTX660 in Healthy Volunteers
This is a Phase 1, single-dose, open-label, randomized, three-period, three-way crossover study in which healthy adult participants will receive three separate single-dose administrations of ASTX660 capsules under three different conditions.
Study Overview
Detailed Description
Participants receiving Treatment A (fasting) will be dosed after having fasted overnight for at least 10 hours.
Participants receiving Treatment B (fed; high-fat/high-calorie meal) will fast overnight for at least 10 hours then consume a Food and Drug Administration (FDA) standard high-fat, high-calorie breakfast beginning 30 minutes before dosing.
Participants receiving Treatment C (fed; low-fat/low-calorie meal) will fast overnight for at least 10 hours then consume an FDA standard low-fat, low-calorie breakfast beginning 30 minutes before dosing.
The duration of the study is expected to be approximately 47 days.
Study Type
Interventional
Enrollment (Actual)
21
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
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Texas
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San Antonio, Texas, United States, 78217
- Worldwide Clinical Trials
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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 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Voluntarily consents to participate in this study and provides written informed consent before the start of any study-specific procedures.
- Male or female.
- Is between 18 and 55 years of age (inclusive).
- Has a body mass index (BMI) between 18 and 32 kg/m2 (inclusive) and weighs a minimum of 50 kg.
- Females must be of non-childbearing potential (defined as surgically sterile [i.e. had a bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 6 months before the first dose of study medication] or postmenopausal for at least 1 year before the first dose of study medication).
- Is willing and able to remain in the study unit for the entire duration of the confinement period.
- Is willing and able to consume the entire FDA standard high-fat and low-fat meal in the timeframe required during the designated study periods.
- Has vital signs (measured sitting after a minimum 3 minutes rest) at screening within the following ranges: heart rate: 40-100 bpm; systolic blood pressure (BP): 90-145 mmHg; diastolic BP: 50-95 mmHg. Out-of-range vital signs may be repeated once at the Investigator's discretion.
Exclusion Criteria:
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, autoimmune, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the participant or the validity of the study results.
- A clinically significant abnormal finding on the physical exam, medical history, electrocardiogram (ECG), or clinical laboratory results at screening.
- Has laboratory values that are not within normal limits for amylase and lipase, phosphorus, alkaline phosphatase (ALP), aspartate transaminase (AST), alanine transaminase (ALT), bilirubin, white blood cell count (WBC) and absolute neutrophil count (ANC), international normalized ratio (INR), C-reactive protein (CRP), or has any other clinically significant abnormal chemistry values in the opinion of the Investigator.
- Has an ECG parameter (confirmed by repeat evaluation) of PR ≥ 200 ms, or QRS ≥ 110 ms, or QT interval corrected by the method of Fridericia (QTcF) > 450 ms at screening visit.
- History or presence of allergic or adverse response to ASTX660 or related drugs or ASTX660 excipients.
- Has been on a significantly abnormal diet (i.e., low-calorie, vegan, or intermittent fasting) during the 4 weeks preceding the first dose of study medication.
- Has participated in another clinical trial (randomized participants only) within 30 days before the first dose of study medication.
- Use of any over-the-counter (OTC) medication (including nutritional or dietary supplements, herbal preparations, or vitamins) within 7 days before the first dose of study medication until the end of study visit without evaluation and approval by the Investigator.
- Use of any prescription medication, except hormonal replacement therapy, from 14 days before the first dose of study medication until the end-of-study visit without evaluation and approval by the Investigator.
- Has been treated with any known drugs that are moderate or strong inhibitors/inducers of cytochrome P450 (CYP) enzymes (e.g., barbiturates, phenothiazines, cimetidine, carbamazepine) or known P-gp inhibitors, or is taking any concomitant medication within 30 days before the first dose of study medication.
- Blood or plasma donation within 30 days before the first dose of study medication until the end-of-study visit. It is recommended that blood/plasma donations not be made for at least 30 days after the end-of-study visit.
- Smoking or use of tobacco- or nicotine-containing products within 60 days before the first dose of study medication until the end-of-study visit.
- Engagement in strenuous exercise from 48 hours before the first dose of study medication until the end-of-study visit.
- Consumption of beverages or foods that contain alcohol, grapefruit, poppy seeds, broccoli, Brussels sprouts, pomegranate, star fruit, char-grilled meat, or caffeine/xanthine from 48 hours before the first dose of study medication until the end-of-study visit. Participants will be instructed not to consume any of the above products; however, allowance for an isolated single incidental consumption may be evaluated and approved by the study Investigator based on the potential for interaction with the study drug.
- Has any prior history of substance abuse or treatment (including alcohol).
- Is a female with a positive pregnancy test result.
- Has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates) or cotinine.
- Has a positive test for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) at screening or has been previously treated for hepatitis B, hepatitis C, or HIV infection.
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Treatment A - Fasting
No food prior to dosing
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Form: capsule; Route of administration: oral
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EXPERIMENTAL: Treatment B - Fed
High-fat/high-calorie meal prior to dosing
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Form: capsule; Route of administration: oral
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EXPERIMENTAL: Treatment C - Fed
Low-fat/low-calorie meal prior to dosing
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Form: capsule; Route of administration: oral
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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
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Maximum plasma concentration
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Predose to 72 hours postdose, up to Day 4
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Pharmacokinetic parameter Tmax
Time Frame: Predose to 72 hours postdose, up to Day 4
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Time to reach maximum plasma concentration
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Predose to 72 hours postdose, up to Day 4
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Pharmacokinetic parameter λz
Time Frame: Predose to 72 hours postdose, up to Day 4
|
Observed terminal rate constant
|
Predose to 72 hours postdose, up to Day 4
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Pharmacokinetic parameter t1/2
Time Frame: Predose to 72 hours postdose, up to Day 4
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Observed terminal half-life
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Predose to 72 hours postdose, up to Day 4
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Pharmacokinetic parameter AUC(0-24h)
Time Frame: Predose to 24 hours postdose, up to Day 4
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Area under the concentration-time curve from time-zero to 24 hours postdose
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Predose to 24 hours postdose, up to Day 4
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Pharmacokinetic parameter AUClast
Time Frame: Predose to 72 hours postdose, up to Day 4
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Area under the concentration-time curve from time-zero to the time of the last quantifiable concentration
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Predose to 72 hours postdose, up to Day 4
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Pharmacokinetic parameter AUCinf
Time Frame: Predose to 72 hours postdose, up to Day 4
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Area under the concentration-time curve from time-zero extrapolated to infinity
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Predose to 72 hours postdose, up to Day 4
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Pharmacokinetic parameter AUCExtrap (%)
Time Frame: Predose to 72 hours postdose, up to Day 4
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Percentage of AUCinf based on extrapolation
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Predose to 72 hours postdose, up to Day 4
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Pharmacokinetic parameter Clast
Time Frame: Predose to 72 hours postdose, up to Day 4
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Last quantifiable concentration determined directly from individual concentration-time data
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Predose to 72 hours postdose, up to Day 4
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Pharmacokinetic parameter Tlast
Time Frame: Predose to 72 hours postdose, up to Day 4
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Time of the last quantifiable concentration
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Predose to 72 hours postdose, up to Day 4
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 20, 2020
Primary Completion (ACTUAL)
August 25, 2020
Study Completion (ACTUAL)
August 25, 2020
Study Registration Dates
First Submitted
July 17, 2020
First Submitted That Met QC Criteria
July 17, 2020
First Posted (ACTUAL)
July 21, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 16, 2020
Last Update Submitted That Met QC Criteria
September 14, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- ASTX660-11
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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