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

Phase 1

Completed

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

• Registration Number: NCT00441987
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-02-28
• Study First Submitted QC: 2007-02-28
• Study First Posted: 2007-03-01
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2010-06
• Last Update Submitted: 2022-04-28
• Last Update Posted: 2022-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 96

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Dose of GSI-953	GSI-953	-

Primary Outcome Measures

Name	Time	Method
Number of participants reporting Adverse Event	10 months	Safety