To assess the safety and tolerability of ascending, multiple, oral doses of GSI-953 in
healthy elderly subjects.
- Men or women, greater than or equal to 65 years of age.
- Women of nonchildbearing potential (WONCP) may be included if they are either
surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for greater
than or equal to 1 year (with FSH greater than or equal to 38 mIU/mL) and must have a
negative pregnancy test result within 48 hours before administration of test article.
Women who are surgically sterile must provide documentation of the procedure by an
operative report or by ultrasound.
- Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight >50 kg.