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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00440492
First received: February 23, 2007
Last updated: December 11, 2007
Last verified: December 2007

February 23, 2007
December 11, 2007
December 2006
Not Provided
To evaluate the effect of PLA-695 on the blood concentrations of methotrexate when administered together.
Same as current
Complete list of historical versions of study NCT00440492 on ClinicalTrials.gov Archive Site
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Study To Evaluate The Pharmacokinetic Interaction Between PLA-695 And Methotrexate In Adults With Rheumatoid Arthritis
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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Arthritis, Rheumatoid
Drug: PLA-695
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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November 2007
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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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00440492
3175A3-104
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Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

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