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

This study has been completed.

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00434785

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: AGG-523	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment
Official Title:	An Ascending, Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of AGG-523 Administered Orally to Healthy Male Japanese Subjects.

Further study details as provided by Wyeth:

Primary Outcome Measures:

Study Start Date:	February 2007
Study Completion Date:	September 2007

Eligibility

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434785

Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	3189A1-105
Study First Received:	February 9, 2007
Last Updated:	December 3, 2007
ClinicalTrials.gov Identifier:	NCT00434785
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 13, 2009