A Study of the Safety, Tolerability, and Pharmacokinetics of AGG-523 in Healthy Japanese Males
Phase 1
Completed
- Conditions
- Healthy
- Registration Number
- NCT00434785
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Brief Summary
To assess the safety and tolerability of ascending, multiple oral doses of AGG-523 in healthy Japanese subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- Not specified
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 Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To assess the safety and PK profile
- Secondary Outcome Measures
Name Time Method