Status:
WITHDRAWN
Effects of Tranilast on Pharmacokinetics of Methotrexate (MTX) in Patients With Rheumatoid Arthritis (RA)
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Nuon Therapeutics, Inc.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The treatment of rheumatoid arthritis has improved considerably in recent years with the understanding that better outcomes can be achieved by optimising the dosage schedule of conventional drugs that...
Detailed Description
THEORETICAL FRAMEWORK:The treatment outcomes in rheumatoid arthritis have dramatically improved with the recognition that the inflammatory component of disease needs to be suppressed optimally at ever...
Eligibility Criteria
Inclusion
- Adult men and non-pregnant, non-lactating women between 18 and 75 years of age. Sexually active females must be of either non-childbearing potential or willing to comply with the contraceptive requirements.
- Body weight greater \>40 kg and \<120 kg with a body mass index (BMI) between 19-31 kg/m2
- Clinical history of rheumatoid arthritis as defined by ACR criteria and currently on a stable dosing regimen of methotrexate 7.5 to 25 mg once weekly, as their only DMARD (no changes in dosing regimen for 4 weeks prior to screening).
- Negative urine pregnancy test (for all women except those with documented proof of hysterectomy or bilateral oophorectomy)
- Subjects who are able and willing to give written consent
Exclusion
- Any clinically relevant abnormality identified on the screening history, physical exam, clinical laboratory evaluations or ECG, with the exception of values related to rheumatoid arthritis.
- Estimated Glomerular Filtration rate \<60mL/min.
- Significant hepatic insufficiency as defined by total bilirubin greater than 25.7umol/L or transaminase(ALT, AST) elevations greater than 2 times the upper limit of the clinical laboratory range. Also any patient with documented cirrhosis or a history consistent with a diagnosis of cirrhosis or hepatitis.
- Patients not on a stable DMARD and/or NSAID drug regimen, or expecting to remain on a stable drug regimen, as defined by starting a new drug or changing dosage within 14 days prior to administration of study medication.
- Patients taking any drugs known to be substrates of CYP2C9 or taking digoxin, or cerivastatin within 14 days prior to Session 1, or taking any drugs known to inhibit or induce CYP2C9.
- Known or suspected hypersensitivity to tranilast or to structurally similar compounds.
- History of recurrent urinary tract infections or kidney stones.
- History of an acute illness within 2 weeks prior to the first dose of study medication.
- History of alcohol abuse within 2 years preceding the first dose of study medication.
- History of gout or hyperuricaemia.
- History of drug abuse within 2 years preceding the first dose of study medication.
- Use of an investigational drug within 30 days preceding the first dose of study medication.
- Donation of blood in excess of 500 mL within 56 days prior to the first dose of study medication.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00717808
Start Date
September 1 2008
End Date
September 1 2009
Last Update
May 28 2015
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