Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses in Healthy

Phase 1

Completed

• Conditions: Healthy Subjects; Osteoarthritis

• Registration Number: NCT00380900
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The purpose of this study is to evaluate the safety and tolerbility of ascending multiple oral doses of AGG-523 in healthy subjects and in subjects with osteoarthritis.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-09-26
• Study First Submitted QC: 2006-09-26
• Study First Posted: 2006-09-27
• Study Completion: 2007-02
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-03
• Last Update Posted: 2007-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Healthy men or women, aged 18 to 40 years and subjects with osteoarthritis of the knee, aged 40 to 75 years.
• Women must be of non-childbearing potential, defined as surgically sterile with documentation of ultrasound.
• Must be nonsmoker or smoke less than 10 cigarettes per day.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Assess the safety of multiple doses of AGG-523 administered to subjects.