NCT00847886

Study of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	LX3305	Daily oral intake of LX3305 for 14 days.
DRUG	LX3305 Placebo	Matching placebo dosing with daily oral intake for 14 days.
DRUG	Methotrexate	Once weekly stable-dose methotrexate.

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2009-02-19
• Last updated: 2010-06-03
• Results posted: 2010-06-03

Locations

1 site across 1 country: United States