Study To Evaluate The Pharmacokinetic Interaction Between PLA-695 And Methotrexate In Adults With Rheumatoid Arthritis

December 11, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

An Open-Label Study To Evaluate The Potential Pharmacokinetic Interaction Between PLA-695 And Methotrexate When Coadministered Orally To Adult Subjects With Rheumatoid Arthritis

The purpose of this study is to determine if PLA-695 changes the blood concentrations of methotrexate when administered together.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
    • Ontario
      • Mississauga, Ontario, Canada, L4W 1N2
    • Quebec
      • Montreal, Quebec, Canada, H3P 3P1
  • United States
    • California
      • Los Angeles, California, United States, 90048
      • Palo Alto, California, United States, 94304
    • New York
      • Lake Success, New York, United States, 11042
      • Rochester, New York, United States, 14642
    • North Carolina
      • Charlotte, North Carolina, United States, 28208
    • Ohio
      • Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men or women of nonchildbearing potential with rheumatoid arthritis (RA), aged 18 to 75 years
  • RA disease onset after 16 years of age and has had the disease for at least 6 months
  • Must be receiving a stable, well-tolerated oral dose of methotrexate (5 to 25 mg) taken once weekly for at least 3 months

Exclusion Criteria:

  • Evidence of unstable clinically significant disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate the effect of PLA-695 on the blood concentrations of methotrexate when administered together.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

February 23, 2007

First Submitted That Met QC Criteria

February 26, 2007

First Posted (Estimate)

February 27, 2007

Study Record Updates

Last Update Posted (Estimate)

December 13, 2007

Last Update Submitted That Met QC Criteria

December 11, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3175A3-104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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