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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-02-28

Brief Summary

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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

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Conditions

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Healthy Subjects Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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AGG-523

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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3189A1-102

Identifier Type: -

Identifier Source: org_study_id