A Study of the Safety, Tolerability, and Pharmacokinetics of AGG-523 in Healthy Japanese Males

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AGG-523

Study type: Interventional

Funder types: Industry

Identifiers

NCT00434785

3189A1-105

Details and patient eligibility

About

To assess the safety and tolerability of ascending, multiple oral doses of AGG-523 in healthy Japanese subjects.

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind