- Female subjects must either be of non-reproductive potential (i.e., post-menopausal by history: >= 60 years old and no menses for >=1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1