The purpose of this study is to evaluate the effects of JNJ-39758979 on the pharmacokinetics (how the body handles a drug) of methotrexate in participants with rheumatoid arthritis.
This is an open-label (physician and participant will know the name of the assigned drug), multi-center, non-randomized, drug-drug interaction study of JNJ-39758979 in participants with rheumatoid arthritis (RA) on a stable oral methotrexate (MTX) dose (7.5 - 25 mg). The treatment phase will last 17 days. Participants will be housed in the clinic for dosing and study procedures from Day -1 to Day 3 and again from Day 13 to Day 17. Participants completing treatment will have a follow-up visit between Days 22 and 25. Participants who discontinue the study prematurely will complete the Day 22 to 25 follow-up procedures at the time of discontinuation or as soon as possible, thereafter. The length of participation in the study for an individual participant may be up to 9 weeks (including screening). Participant safety will be monitored. Day 1: A single oral dose of the participant's weekly methotrexate dose. Days 3-15: Weekly MTX co-administered with three 100-mg, enteric-coated tablets of JNJ-39758979, administered daily.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Day 1: MTX: Route=oral use, single dose of participant's weekly MTX dose; Days 3-15: MTX: Route=oral use, single dose of participant's weekly MTX dose and JNJ 39758979: Type=exact, unit=mg, number=300, form=tablet, route=oral use, administered daily.
Unnamed facility
Daytona Beach, Florida, United States
Unnamed facility
Duncansville, Pennsylvania, United States
Unnamed facility
Dallas, Texas, United States
Unnamed facility
Berlin, Germany
Unnamed facility
Munich, Germany
Blood levels of methotrexate
To assess the effect of multiple doses of JNJ-39758979 on blood levels of methotrexate
Time frame: Up to approximately 7 weeks
Blood levels of JNJ 39758979
To assess the effect of MTX on the blood levels of JNJ 39758979
Time frame: Up to approximately 7 weeks
The number of participants with adverse events
Time frame: Up to approximately 7 weeks
Clinical laboratory tests
Blood and urine tests
Time frame: Up to approximately 7 weeks
Electrocardiograms
Time frame: Up to approximately 7 weeks
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