 - Male or female, ages 18-65 years, inclusive, at Screening. Eligible female subjects of childbearing potential with a nonsterilized male sexual partner must agree to use a hormonal contraceptive, barrier contraceptive with additional spermicide, or an intrauterine device beginning 30 days prior to study drug administration and continuing until 7 days after the end of the study. Female subjects who are postmenopausal must have been postmenopausal for 1 year if they wish not to use contraceptives. If postmenopausal status is questionable, the subjects follicle stimulating hormone FSH level must be checked and must be elevated and consistent with postmenopausal levels i.e., 40 IUL; otherwise these subjects must agree to use contraceptives listed above. 