Back to resultsStudy To Evaluate The Pharmacokinetic Interaction Between PLA-695 And Methotrexate In Adults With Rheumatoid Arthritis
Primary Purpose
Arthritis, Rheumatoid
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
PLA-695
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
To evaluate the effect of PLA-695 on the blood concentrations of methotrexate when administered together.
Secondary Outcome Measures
Full Information
NCT ID
NCT00440492
First Posted
February 23, 2007
Last Updated
December 11, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00440492
Brief Title
Study To Evaluate The Pharmacokinetic Interaction Between PLA-695 And Methotrexate In Adults With Rheumatoid Arthritis
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine if PLA-695 changes the blood concentrations of methotrexate when administered together.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
PLA-695
Primary Outcome Measure Information:
Title
To evaluate the effect of PLA-695 on the blood concentrations of methotrexate when administered together.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28208
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 1N2
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3P 3P1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Study To Evaluate The Pharmacokinetic Interaction Between PLA-695 And Methotrexate In Adults With Rheumatoid Arthritis
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