 - Females must be non-pregnant, non-lactating, surgically sterile for at least 3 months, post-menopausal for at least 1 years with follicle stimulating hormone FSH greater than or equal to 40 mIUmL, or willing to use an approved method of contraception from 35 days prior to first study drug administration. Approved methods of contraception include: a non-hormonal intrauterine device IUD with spermicide, a female condom with spermicide, a diaphragm with spermicide, a cervical cap with spermicide, use of a condom with spermicide by sexual partner or sterile sexual partner. 