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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: GSI-953

Study type: Interventional

Funder types: Industry

Identifiers

NCT00441987

3183A1-101

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: Male

Ages: 20 to 120 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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96 participants in 1 patient group

Single Dose of GSI-953

Experimental group

Treatment:

Drug: GSI-953