The purpose of the study is to evaluate the effect of LX3305 on methotrexate (MTX) pharmacokinetics and to evaluate the safety and tolerability of LX3305 given over 14 days in subjects with stable rheumatoid arthritis that are receiving stable doses of MTX.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
15
Daily oral intake of LX3305 for 14 days.
Matching placebo dosing with daily oral intake for 14 days.
Once weekly stable-dose methotrexate.
Metroplex Clinical Research Center
Dallas, Texas, United States
Methotrexate Maximum Plasma Concentration
Time frame: Day 15
Time to Reach Maximum Plasma Concentration of Methotrexate
Time frame: Day 15
Half-life of Methotrexate in Plasma
Time frame: Day 15
Amount of Methotrexate Excreted in the Urine
Time frame: Day 15
7-Hydroxymethotrexate (7-OH-MTX) Maximum Plasma Concentration
7-OH-MTX is the primary metabolite of methotrexate.
Time frame: Day 15
Time to Reach Maximum Plasma Concentration of 7-OH-MTX
Time frame: Day 15
Amount of 7-OH-MTX Excreted in the Urine
Time frame: Day 15
Maximum Plasma Concentration of LX3305 in the Presence of MTX
Time frame: Day 15
Time to Maximum Plasma Concentration of LX3305 in the Presence of MTX
Time frame: Day 15
Half-life of LX3305 in Plasma in the Presence of MTX
Time frame: Day 15
Percentage of Change From Baseline in Absolute Total Lymphocyte Count at Day 15
Baseline was defined as pre-dose on Day 1.
Time frame: Day 15
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