Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses in Healthy
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00380900
Collaborator
(none)
1
7.1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
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.
Study Start Date
:
Jul 1, 2006
Actual Study Completion Date
:
Feb 1, 2007
Outcome Measures
Primary Outcome Measures
- Assess the safety of multiple doses of AGG-523 administered to subjects. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 40 Years
Sexes Eligible for Study:
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Philadelphia | Pennsylvania | United States | 19148 |
Sponsors and Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
- Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00380900
Other Study ID Numbers:
- 3189A1-102
First Posted:
Sep 27, 2006
Last Update Posted:
Dec 5, 2007
Last Verified:
Dec 1, 2007
Additional relevant MeSH terms: