ABOUT THIS STUDY
1. Healthy male and/or female subjects of non-child bearing 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).
2. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
3. An informed consent document signed and dated by the subject.
4. 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, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14
drinks/week for males (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
- Screening supine blood pressure >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), on a
single measurement (confirmed per local SOP) .
- 12 lead ECG demonstrating QTc >450 or a QRS interval >120 msec at Screening. If QTc
exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times
and the average of the three QTc values should be used to determine the subject's
- 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. As an
exception, acetaminophen/paracetamol may be used at doses of <=1 g/day. Limited use of
non prescription medications that are not believed to affect subject safety or the
overall results of the study may be permitted on a case-by-case basis following
approval by the sponsor.
- Herbal supplements and hormonal methods of contraception (including oral and
transdermal contraceptives, injectable progesterone, progestin subdermal implants,
progesterone-releasing IUDs and postcoital contraceptive methods) and hormone
replacement therapy must be discontinued at least 28 days prior to the first dose of
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 56 days prior to dosing.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Unwilling or unable to comply with the Lifestyle Guidelines described in this
- 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.
- History of seizure or of a condition with risk of seizures. (A history of 1 febrile
seizure in childhood does not exclude the subject.)
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5
cigarettes per day.
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