- Females must be surgically sterile, postmenopausal (at least 1 year), or have negative pregnancy test at screening on serum sample and prior to first dose of study drug on urine sample. Females not surgically sterile or postmenopausal (at least 1 year) and non-vasectomized males must practice at least 1 of the following:total abstinence from sexual intercourse (min.1 complete menstrual cycle),a vasectomized partner, hormonal contraceptives for at least 3 months prior to study drug administration, or double-barrier method.