Effect of Food on the Pharmacokinetics of ASTX660 in Healthy Volunteers

Exclusion Criteria

• •1. 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.
• •2. A clinically significant abnormal finding on the physical exam, medical history, electrocardiogram (ECG), or clinical laboratory results at screening.
• •3. 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.
• •4. 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.
• •5. History or presence of allergic or adverse response to ASTX660 or related drugs or ASTX660 excipients.
• •6. 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.
• •7. Has participated in another clinical trial (randomized participants only) within 30 days before the first dose of study medication.
• •8. 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.
• •9. 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.
• •10. 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.
• •11. 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.
• •12. 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.
• •13. Engagement in strenuous exercise from 48 hours before the first dose of study medication until the end-of-study visit.
• •14. 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.
• •15. Has any prior history of substance abuse or treatment (including alcohol).
• •16. Is a female with a positive pregnancy test result.
• •17. Has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates) or cotinine.
• •18. 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.