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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Osteoarthritis; Healthy Subjects

Treatments: Drug: AGG-523

Study type: Interventional

Funder types: Industry

Identifiers

NCT00380900

3189A1-102

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind