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

Phase 1CompletedNCT00434785

Wyeth is now a wholly owned subsidiary of Pfizer

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Healthy

Interventions

AGG-523DRUG

Eligibility

Sex: MALEMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Ikebukuro, Tokyo, Japan

Outcomes

Primary Outcomes

To assess the safety and PK profile

Data from ClinicalTrials.gov

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