- Women of nonchildbearing potential, or men, aged 18 to 55 years inclusive on study day
1. Women of nonchildbearing potential may be included if they are either surgically
sterile (hysterectomy and/or oophorectomy) or postmenopausal for ≥1 year (with a
follicle-stimulating hormone [FSH] level of ≥38 mIU/mL). Women who are surgically
sterile must provide documentation of the procedure by an operative report or
ultrasound scan. 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.
- Body mass index in the range of 18 to 32 kg/m2 and body weight ≥50 kg.
- Hemoglobin no lower than 0.4 g/dL, less than the lower limit of the normal range, and
white blood cell count no lower than 0.5 103/mm3, less than the lower limit of the of
the normal range at screening and day -1. Hematocrit and absolute neutrophil count
within normal range at screening and on day -1.
- Women of childbearing potential.
- Presence or history of any disorder that may prevent the successful completion of the
study.
- Any unstable psychiatric condition, which may prevent the successful and safe
completion of the study in the opinion of the investigator.