Status:
COMPLETED
A Study of the Safety, Tolerability, and Pharmacokinetics of AGG-523 in Healthy Japanese Males
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Healthy
Eligibility:
MALE
20-40 years
Phase:
PHASE1
Brief Summary
To assess the safety and tolerability of ascending, multiple oral doses of AGG-523 in healthy Japanese subjects.
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Men aged 20 to 40 years, inclusive, at screening; sexually active men must agree to use a medically acceptable form of contraception during the study and continue for 12 weeks after test article administration.
- Body mass index (BMI) in the range of 17.6 to 26.4 Kgm2, and body weight \>45 kg.
- Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12 lead ECG.
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
End Date :
September 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00434785
Start Date
February 1 2007
End Date
September 1 2007
Last Update
December 5 2007
Active Locations (1)
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1
Ikebukuro, Tokyo, Japan, 1520003