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Clinical Trials/NCT00380900
NCT00380900
Completed
Phase 1

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 Pfizer0 sitesJuly 2006

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Healthy Subjects
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Primary Endpoint
Assess the safety of multiple doses of AGG-523 administered to subjects.
Status
Completed
Last Updated
18 years ago

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.

Registry
clinicaltrials.gov
Start Date
July 2006
End Date
February 2007
Last Updated
18 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility Criteria

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.

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