 - men and surgically sterile or post-menopausal at least since 12 months amenorrhoea women aged 18 years or older. The non-childbearing potential of women needs to be confirmed by medical record or in writing by a gynecologist, if that is not possible a follicle stimulating hormone FSH test will be performed on female subjects to confirm menopause, unless they are receiving hormonal replacement therapy for treatment of menopause symptoms; 