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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00547560

Enrollment

Registered

2007-10-22

Start date

2007-08-31

Completion date

2009-10-31

Last updated

2011-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Alzheimer Disease

Brief summary

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

Interventions

DRUGGSI-953

Oral capsule, 10- and 50-mg, either once a day for 14 days or twice a day for 14 days, depending on cohort assignment.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
The pharmacokinetic and pharmacodynamic profile for the elderly subjects.	6 months

Secondary

Measure	Time frame
Pharmacokinetics (PK)	6 months
Pharmacodynamics (PD)	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026