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NCT00440492 Clinical Trial

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

Arthritis, Rheumatoid Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00440492
Other study ID # 3175A3-104
Secondary ID
Status Completed
Phase Phase 1
First received February 23, 2007
Last updated December 11, 2007
Start date December 2006
Est. completion date November 2007

Study information
Verified date December 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority Canada: Health CanadaUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date November 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• PLA-695

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the effect of PLA-695 on the blood concentrations of methotrexate when administered together.
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