Study to Evaluate the Food Effect of Single-dose Bioavailability of Pracinostat in Healthy Adult Subjects

Exclusion Criteria

• •Subject is mentally or legally incapacitated or has significant emotional problems at the time of screening visit or expected during the conduct of the study.
• •History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
• •History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
• •History or presence of alcoholism or drug abuse within the past 2 years prior to screening.
• •History or presence of hypersensitivity or idiosyncratic reaction to the study medication or related compounds.
• •History of prolonged QT syndrome.
• •Positive urine drug and alcohol results at screening or check-in.
• •Positive results at screening for HIV, HBsAg or HCV.
• •Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening.
• •Seated heart rate is lower than 40 bpm or higher than 99 bpm at screening.
• •QTcF interval, is \>430 msec (males) or \>450 msec (females) or deemed clinically abnormal by the PI at screening or Period 1 check-in
• •Unable to refrain from or anticipates the use of:
• •* Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning approximately 14 days prior to the first dose of study medication and throughout the study.
• •* Any drugs known to be significant inducers of CYP enzymes, including St. John's Wort, for 28 days prior to the first dose dosing of study medication and throughout the study. Appropriate sources will be consulted by the PI or designee to confirm lack of PK/pharmacodynamics interaction with study medication.
• •Have been on a diet incompatible with the on-study diet, in the opinion of the PI, within the 28 days prior to the first dose of study medication(s), and throughout the study.
• •Hemoglobin, platelet count or absolute neutrophils below the lower limit of normal at screening.
• •Potassium or magnesium below the lower limit of normal at screening.
• •Aspartate aminotransferase and alanine aminotransferase above upper limit of normal at screening.
• •Donation of blood or significant blood loss within 56 days prior to the first dose of study medication.
• •Plasma donation within 7 days prior to the first dose of study medication.
• •Participation in another clinical trial within 28 days prior to the first dose of study medication.