A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Test Article or Placebo Administered Orally to Healthy and Osteoarthritis Subjects.

Wyeth is now a wholly owned subsidiary of Pfizer1 site in 1 countryStarted: July 1, 2006Last updated: December 5, 2007

Conditions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor
Locations: 1
Primary Endpoint: Assess the safety of multiple doses of AGG-523 administered to subjects.

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Factorial
Primary Purpose: Treatment
Masking: Double

Eligibility Criteria

Ages: 18 Years to 40 Years (Adult)
Sex: All
Accepts Healthy Volunteers: Yes

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Sponsor Class

Industry

Study Sites (1)

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