JNJ-38518168 / MTX
DrugDay 1: MTX: Route=oral use, single dose of participant's weekly MTX dose
NCT Number: NCT01450982
The purpose of this study is to evaluate the effects of JNJ-38518168 on the pharmacokinetics (how the body handles a drug) of methotrexate in participants with rheumatoid arthritis.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Anniston, Alabama, United States
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-38518168 in participants with rheumatoid arthritis (RA) on a stable oral methotrexate (MTX) dose (7.5-25 mg). The treatment phase will last 16 days. Participants will be housed in the clinic for dosing and study procedures from Day -1 to Day 2 and again from Day 14 to Day 16. 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 duration of participation in the study for an individual participant will be up to 7 weeks (including screening). Participant safety will be monitored. Day 1: A single oral dose of the participant's weekly methotrexate dose. Days 2-15: Weekly MTX co-administered with two 50-mg capsules of JNJ-38518168, administered daily.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Day 1: MTX: Route=oral use, single dose of participant's weekly MTX dose
Time frame: Up to approximately 7 weeks
To assess the effect of multiple doses of JNJ-38518168 on blood levels of methotrexate
Time frame: Up to approximately 7 weeks
To assess the effect of methotrexate on the blood levels of JNJ-38518168
Time frame: Up to approximately 7 weeks
Time frame: Up to approximately 7 weeks
Blood and urine tests
Time frame: Up to approximately 7 weeks
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Industry
A Study to Investigate the Effects of JNJ-38518168 on Methotrexate Pharmacokinetics in Rheumatoid Arthritis Participants on a Stable Methotrexate Dose
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