1. Women of nonchildbearing potential aged 20 to 64 years. Must have a negative pregnancy
test result within 48 hours before administration of test article. Women who are
surgically sterile must provide documentation of the procedure by an operative report
or by ultrasound scan.
2. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight must be at
least 45 kg.
3. Healthy as determined by the investigator on the basis of screening evaluation.
1. Any significant cardiovascular, hepatic, renal, respiratory, gynecologic
gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or
2. Any history of drug abuse or admitted alcohol abuse or history of alcohol use that may
interfere with the subject's ability to comply with the protocol requirements.
3. Use of any investigational drug within 90 days before study day 1, use of any
prescription drug within 30 days before study day 1, consumption of any
caffeine-containing products (eg, coffee, tea, chocolate, or cola) or alcoholic
beverages within 48 hours before study day 1, consumption of grapefruit or
grapefruit-containing products within 72 hours before study day 1, use of any
over-the-counter drugs, including herbal supplements (except for the occasional use of
vitamins ?100% of the recommended daily allowance), within 14 days before study day 1,
or the donation of blood within 90 days before study day 1.