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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00440492

Enrollment

Unknown

Registered

2007-02-27

Start date

2006-12-31

Completion date

2007-11-30

Last updated

2007-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid

Brief summary

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

Interventions

DRUGPLA-695

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026