- Gender: Male or eligible female subjects. A female subject is eligible to participate if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g., age appropriate, history of vasomotor symptoms. OR Childbearing potential with a negative pregnancy test at screening and agreeable to using one of the acceptable contraceptive methods consistently and correctly (i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study). An eligible female is also not lactating nor planning on becoming pregnant during the study.