Status:
COMPLETED
Study Evaluating Safety of GSI 136 in Young and Elderly Japanese Males
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Alzheimer Disease
Healthy
Eligibility:
MALE
20+ years
Phase:
PHASE1
Brief Summary
This is a first-in-human study of GSI-136, a gamma-secretase inhibitor being developed for the treatment of Alzheimer disease. This study will take place in Japan only and will provide an initial asse...
Eligibility Criteria
Inclusion
- Inclusion Criteria .
- Men aged 20 to 45 years, or greater than 65 years, inclusive, at screening and who agree to use a medically acceptable form of contraception during the study and to continue its use for 12 weeks after test article administration.
- Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory tests, vital sign measurements and 12-lead electrocardiogram (ECG).
- Exclusion Criteria
- Presence or history of any disorder that may prevent the successful completion of the study.
- Any history or presence of chronic respiratory disorder or disease including but not limited to asthma, sleep apnea, or chronic obstructive pulmonary disease (COPD).
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2008
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00719394
Start Date
March 1 2008
End Date
August 1 2008
Last Update
July 10 2009
Active Locations (1)
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1
Tokyo Heat Center
Tokyo, Japan, 141-0001