Female subjects must be surgically sterile, or have a monogamous partner who is surgically sterile, or at least years postmenopausal, or who commits to use an acceptable form of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives, or abstinence) for the duration of the study and for months following the last dose of study treatment. Are surgically sterile, OR Are surgically sterile, OR If sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods) Be of non-childbearing potential: Clearly premenarchal or documented surgically sterile Are surgically sterile, OR documented surgically sterile The patient, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods) Are surgically sterile, or If sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods) Female patients who are post-menopausal or surgically sterile. Patients, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods) Patients who are sexually active and unwilling to use effective contraception (if they are not already surgically sterile) For men: Must be surgically sterile or compliant with a contraceptive regimen during and for months after the treatment period Are surgically sterile, OR Are surgically sterile, or Are surgically sterile, OR Are surgically sterile, OR For men: Must be surgically sterile, or compliant with a contraceptive regimen during and for months after the treatment period Were surgically sterile, OR Are surgically sterile, OR Are surgically sterile, OR Surgically sterile OR Are surgically sterile, OR Are surgically sterile, OR Females of childbearing potential must be surgically sterile, have a sterile male partner, be premenarchal or at least years postmenopausal, practice abstinence or otherwise must use effective methods of contraception from the time of initiation of investigational product. Surgically sterile Using adequate contraceptive measures, be surgically sterile or post-menopausal A medically accepted method of contraception to be used by women of childbearing potential (not surgically sterile or at least months naturally postmenopausal) Are surgically sterile, or Surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method. They are using an effective method of contraception from screening to the end of the study, unless their sexual partner is surgically sterile Surgically sterile (i.e., hysterectomy, tubal ligation, vasectomy). Are surgically sterile, or