- Healthy male subjects and women of non-child bearing potential between the ages of 21
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 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs).
- An informed consent document signed and dated by the subject or a legally acceptable
- 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) or clinical findings at Screening.
- A positive urine drug screen.
- Subjects with hepatic dysfunction, defined as aspartate aminotransferase (AST) and/or
alanine aminotransferase (ALT) >1.5 times the upper limit of the normal range at
Screening. A retest may be done if AST and/or ALT within 1.5- to 2- times the upper
limit of the normal range at Screening, and the average of the first and repeated test
values should be used to decide the eligibility.