At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 15 enrolled
Drug / intervention
LX3305 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis
In Brief
A Phase 1 clinical trial evaluating LX3305, LX3305 Placebo, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 15 participants across 1 site.
Detailed Summary
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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2009
First PostedFeb 2009
Primary CompletionMar 2009
TodayJul 2026
First PostedFeb 19, 2009
Enrollment StartFeb 1, 2009
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.4 years ago
Interventions
LX3305drug
Daily oral intake of LX3305 for 14 days.
LX3305 Placebodrug
Matching placebo dosing with daily oral intake for 14 days.
Methotrexatedrug
Once weekly stable-dose methotrexate.