A Pharmacokinetic Study to Determine the Oral Bioavailability of Methotrexate in Patients With Inflammatory Bowel Disease

National Center for Research Resources (NCRR)

Status: Completed

Conditions: Inflammatory Bowel Disease

Treatments: Drug: Methotrexate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00035074

NCRR-M01RR00240-1757

Details and patient eligibility

About

Patients with inflammatory bowel disease (IBD) who require methotrexate (MTX)for treatment currently receive this drug by injection. MTX is also available as a pill that can be given by mouth but it is not known how well the drug enters the body in patients with Crohn's disease or ulcerative colitis. This study is being done to compare how much MTX enters the body when the drug is taken by mouth compared to when it is given by injection. If the drug is well absorbed, it may allow patients to receive the drug by mouth.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Adult or pediatric patients with IBD (CD or UC) currently receiving MTX as part of their clinical care.
• Patients must be receiving weekly MTX at a dose between 7.5 and 40 mg/m2.
• Weight >= 12 kg.
• Normal serum creatinine.