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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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GSI+Placebo

Group Type OTHER

GSI-953

Intervention Type DRUG

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

Interventions

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GSI-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.

Intervention Type DRUG

Other Intervention Names

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Begacestat, WAY-210953, PF-05212362

Eligibility Criteria

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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.