Status:
COMPLETED
Study Evaluating the Safety and Pharmacokinetics of a Single Dose of GSI-953
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Healthy
Eligibility:
MALE
20-120 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00441987
Start Date
February 1 2007
End Date
July 1 2009
Last Update
May 3 2022
Active Locations (1)
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1
Kitashinagawa, Shinagawa-ku, Japan, 141-0001