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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:2/24/2017
Start Date:February 2014
End Date:March 2014

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A 2-Cohort Study to Evaluate the Effect of Food and the Effect of Cigarette Smoking on the Single-Dose Bioavailability of Pracinostat in Healthy Adult Subjects

Open label study of Pracinostat will be tested to assess the effect of food on the
single-dose pharmacokinetics in healthy non-smoking and smoking adult subjects under fasted
and fed conditions.


Inclusion Criteria:

- Healthy, adult, male or female, 18-55 years of age, inclusive, at screening.

- Cohort 1 only: continuous nonsmoker who has not used nicotine-containing products for
at least 6 months prior to the first dose and confirmed by urine cotinine test at
screening.

- Cohort 2 only: moderate to heavy smokers defined as > 1 pack of cigarettes per day or
> 39 cigarettes per week for at least 6 months prior to the first dose and confirmed
by urine cotinine test at screening.

- Body Mass Index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.

- Medically healthy with no clinically significant medical history, physical
examination, laboratory profiles, vital signs or ECGs, as deemed by the PI.

- For a female of non-childbearing potential:

- A non vasectomized, male subject must agree to use a condom with spermicide or
abstain from sexual intercourse during the study until 90 days beyond the last dose
of study medication. (No restrictions are required for a vasectomized male provided
his vasectomy has been performed 4 months or more prior to study start. A male who
has been vasectomized less than 4 months prior to study start must follow the same
restrictions as a non vasectomized male).

- Understands the study procedures in the informed consent form (ICF), and be willing
and able to comply with the protocol

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.
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Tempe, Arizona 85283
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Tempe, AZ
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