ABOUT THIS STUDY
- Healthy male and/or female subjects (of non childbearing potential) between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
- Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs).
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular (including hyperlipidemia), pancreatic,
hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but
excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- History of febrile illness within 5 days prior to the first dose.
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 14 drinks/week for females or 21
drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer
or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- Treatment with an investigational drug within 30 days ( or as determined by the local
requirement, whichever is longer) or 5 half-lives preceding the first dose of study
- 12-lead ECG demonstrating QTc >450 msec at screening. If QTc exceeds 450msec, the ECG
should be repeated two more times and the average of the three QTc values should be
used to determine the subject's eligibility.
- Females of childbearing potential.
- Use of prescription or nonprescription drugs, and dietary supplements within 7 days or
5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal
supplements and hormonal replacement therapy must be discontinued 28 days prior to the
first dose of study medication. As an exception, ibuprofen may be used at doses of up
to 1800 mg/day with food. Limited use of non-prescription medications that are not
believed to affect subject safety or overall results of the study may be permitted on
a case -by-case basis following approval by the sponsor.
- Unwillingness to refrain from consumption of grapefruit or grapefruit/pomelo
containing products within 7 days prior to the first dose of study medication until
the completion of the follow-up visit.
- Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
- Unwilling or unable to comply with the Lifestyle guidelines described in this
- Subject is the Investigator or sub-Investigator. research assistant, pharmacist, study
coordinator, other staff, or a relative of study personnel directly involved with the
conduct of the study.
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study.
- The use of marijuana (or other illicit drugs) within 30 days of randomization.
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