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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: GSI-953

Study type: Interventional

Funder types: Industry

Identifiers

NCT00547560

B1941003

3183A1-102

Details and patient eligibility

About

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

Enrollment: 49 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

49 participants in 1 patient group

GSI+Placebo

Other group

Treatment:

Drug: GSI-953