Study Evaluating Multiple Doses Of GSI-953 Within The Elderly Population

An Ascending Multiple Dose Study Of The Safety, Pharmacokinetics, And Pharmacodynamics Of GSI-953 Administered Orally To Healthy Elderly Subjects

To assess the safety and tolerability of ascending, multiple, oral doses of GSI-953 in healthy elderly subjects.

Inclusion Criteria:

• 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.

Exclusion Criteria:

n/a