 - Female subjects must be post-menopausal one year or greater without menses, surgically incapable of childbearing, or practicing an acceptable method of birth control. Acceptable methods may include intrauterine device, spermicide and barrier, abstinence and hormonal contraception. A female subject must agree to practice an acceptable method of birth control during study period and for 12 weeks after study terminates. She must have had a negative serum pregnancy test during the screening visit and a negative urine pregnancy test on the day of treatment prior to study drug dosing. 