 - Women are eligible to participate if they are of non-childbearing potential or have documentation of a negative pregnancy test serum or urine β-hCG within 3 days of registration. Sexually active pre-menopausal women of childbearing potential must agree to use adequate, highly effective contraceptive measures, starting with the first dose of study drug and for 120 days after the last dose of last study drug. Effective birth control includes a intrauterine device IUD plus one barrier method; b oral, implantable, or injectable contraceptives plus one barrier method; or c 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides creams or gels that contain a chemical to kill sperm. Women of childbearing potential are those who have not been surgically sterilized or have not been free from menses for 1 year. 