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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: GSI-953

• Registration Number: NCT00547560
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-10-18
• Study First Submitted QC: 2007-10-18
• Study First Posted: 2007-10-22
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-01
• Last Update Posted: 2011-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GSI+Placebo	GSI-953	-

Primary Outcome Measures

Name	Time	Method
The pharmacokinetic and pharmacodynamic profile for the elderly subjects.	6 months

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK)	6 months
Pharmacodynamics (PD)	6 months

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Miami, Florida, United States