Study Evaluating the Safety and Pharmacokinetics of a Single Dose of GSI-953

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

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-07-31

Brief Summary

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The purpose of the protocol is to assess the initial pharmacokinetic (PK) profile of a single oral dose of GSI-953 to healthy male Japanese subjects and healthy elderly male Japanese 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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Single Dose of GSI-953

Group Type EXPERIMENTAL

GSI-953

Intervention Type DRUG

Interventions

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GSI-953

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy males aged 20 - 40 and healthy males aged greater than 65.
* Body mass index range of 17.6 - 26.4 kg/m2 greater than or equal to 45 kg.
* Non-smokers or smoker of fewer than 10 cigarettes a day.

Minimum Eligible Age

20 Years

Maximum Eligible Age

120 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes