1. Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years inclusive at
WONCBP may be included if they are either surgically sterile (hysterectomy and/or
oophorectomy) or postmenopausal for ≥1 year (with follicle-stimulating hormone [FSH]
≥38 mIU/mL) and 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. Sexually
active men must agree to use a medically acceptable form of contraception during the
study and continue it for 12 weeks after test article administration.
2. Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg.
3. Healthy as determined by the investigator on the basis of screening evaluations.
1. Women of childbearing potential.
2. Presence or history of any disorder that may prevent the successful completion of the
3. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal,
endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.