Effect of Food on the Pharmacokinetics of Decitabine/Tetrahydrouridine Combination Capsules in Healthy Adult Subjects

Exclusion Criteria

• •History (within 3 years prior to screening) or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition, including the presence of laboratory abnormalities, that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
• •Any serious medical condition, clinically significant laboratory abnormality, or psychiatric illness that would prevent the subject from signing the Informed Consent Form.
• •Used any prescribed systemic or topical medication within 30 days of the first dose administration.
• •Used any non-prescribed systemic (including herbal medicines, e.g. St. John's Wort) or topical medication within 7 days of the first dose administration (with the exception of vitamin/mineral supplements)
• •Subjects who have any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion (ADME), including a past cholecystectomy.
• •Exposed to an investigational drug (new chemical entity) within 90 days preceding the first dose administration or currently enrolled in any investigational trials.
• •Donated blood or plasma within 8 weeks preceding the first dose administration.
• •History of multiple drug allergies.
• •Any clinically significant allergic disease (excluding nonactive hayfever).
• •History of drug abuse within 2 years prior to dosing, or a positive drug test at screening or either check-in.
• •History of alcohol abuse within 2 years prior to dosing, or a positive alcohol test at screening or either check-in.
• •Smokers or users of other tobacco products (e.g., chewing tobacco, or those using nicotine-containing products (i.e., patches, gum) within 3 months prior to screening, or a positive urine cotinine test at screening or either check-in.
• •Known to have serum hepatitis or known to be a carrier of the hepatitis B surface antigen (HBsAg) or hepatitis C antibody, or tests positive for HIV (human immunodeficiency virus) antibodies at screening.
• •Subject must not consume beverages and foods containing grapefruit, broccoli, poppy seeds, Brussels sprouts, pomegranate, star fruit, char-grilled meat, or caffeine/xanthine from 48 hours prior to the first dose of study medication until the end-of-study visit. Subjects 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.