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

This study has been completed.

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00380900

First received: September 26, 2006

Last updated: December 3, 2007

Last verified: December 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

September 26, 2006

Last Updated Date

December 3, 2007

Start Date ^ICMJE

July 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00380900 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Healthy Subjects
Osteoarthritis

Intervention ^ICMJE

Drug: AGG-523

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00380900

Other Study ID Numbers ^ICMJE

3189A1-102

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

Wyeth is now a wholly owned subsidiary of Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Wyeth is now a wholly owned subsidiary of Pfizer

Information Provided By

Wyeth is now a wholly owned subsidiary of Pfizer

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top