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PLA-695

Phase 1

Arthritis, Rheumatoid | Small molecule | Immunology |Pfizer, Inc.|Last Updated: Aug 5, 2008

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment -

FDA Designations

No designations recorded

Clinical trial landscape

PLA-695 · 2 trials · 2 indications

Phase 1 2
NCT00440492Study To Evaluate The Pharmacokinetic Interaction Between PLA-695 And Methotrexate In Adults With Rheumatoid ArthritisArthritis, Rheumatoid
COMPLETED- Analytics
NCT00366262Study Evaluating the Gastrointestinal Safety of PLA-695 Compared to Placebo and NaproxenHealthy
COMPLETED- Analytics
PHASE1COMPLETED
Study To Evaluate The Pharmacokinetic Interaction Between PLA-695 And Methotrexate In Adults With Rheumatoid Arthritis
Arthritis, RheumatoidUnlock trial analytics
PHASE1COMPLETED
Study Evaluating the Gastrointestinal Safety of PLA-695 Compared to Placebo and Naproxen
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the effect of PLA-695 on the blood concentrations of methotrexate when administered together.
The rate of erosions and ulcers present after 7 days of treatment for PLA-65 will be compared to placebo and naproxen.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
PLA-695DRUG -
NaproxenDRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites9

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 w...

Countries:United StatesCanada
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Frequently asked questions about PLA-695

What is PLA-695 used for?

PLA-695 is an investigational small molecule being studied for use in healthy volunteers and in adults with rheumatoid arthritis. It is in Phase 1 clinical development for immunology-related conditions. PLA-695 is not approved and remains under investigation.

Who makes PLA-695?

PLA-695 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The company is conducting early-stage clinical research on this investigational small molecule.

What phase is PLA-695 in?

PLA-695 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Its clinical program includes completed Phase 1 studies in healthy volunteers and in adults with rheumatoid arthritis.

What clinical trials is PLA-695 in?

PLA-695 has been studied in two completed Phase 1 trials. NCT00366262 evaluated gastrointestinal safety compared to placebo and naproxen in healthy volunteers in the United States. NCT00440492 evaluated a pharmacokinetic interaction with methotrexate in adults with rheumatoid arthritis in the United States and Canada.

Is PLA-695 the same as any other drug?

No alternative names for PLA-695 have been reported. The drug is identified solely by the code name PLA-695 in its clinical trial records and development program.