Study of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: LX3305; Drug: LX3305 Placebo; Drug: Methotrexate

• Registration Number: NCT00847886
• Lead Sponsor: Lexicon Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-17
• Study First Submitted QC: 2009-02-17
• Study First Posted: 2009-02-19
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2010-04-19
• Status Verified: 2010-06
• Results First Submitted QC: 2010-06-01
• Last Update Submitted: 2010-06-01
• Results First Posted: 2010-06-03
• Last Update Posted: 2010-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Males and females ≥ 18 years old
• Must be willing to practice 2 adequate methods of contraception for the duration of the study
• Rheumatoid arthritis present for at least 3 months; functional class I, II, or III as defined by ACR criteria
• Treatment with methotrexate (7.5 to 25 mg per week) for at least the last 3 months, and currently receiving stable dose methotrexate for at least one month prior to the start of the study
• Ability to provide written informed consent

Exclusion Criteria

• Women who are pregnant or nursing
• History of other current inflammatory arthritis
• History of opportunistic infection
• History of recurrent infections or current infection 2 weeks prior to start of study
• Presence of significant, uncontrolled medical problems
• Treatment with any disease-modifying anti-rheumatoid drugs other than methotrexate within 4 weeks prior to start of study
• Use of chondroitin sulfate, glucosamine sulfate, minocycline, or matrix metalloproteinase inhibitors, H-2 blockers, proton pump inhibitors, or misoprostol within 4 weeks prior to study start
• Receipt of live vaccine within 8 weeks prior to study start
• Rheumatoid arthritis, functional class IV as defined by ACR criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LX3305	LX3305	Daily oral intake of LX3305 for 14 days.
LX3305	Methotrexate	Daily oral intake of LX3305 for 14 days.
LX3305 Placebo	LX3305 Placebo	Matching placebo dosing with daily oral intake for 14 days.
LX3305 Placebo	Methotrexate	Matching placebo dosing with daily oral intake for 14 days.

Primary Outcome Measures

Name	Time	Method
Methotrexate Maximum Plasma Concentration	Day 15
Time to Reach Maximum Plasma Concentration of Methotrexate	Day 15
Half-life of Methotrexate in Plasma	Day 15
Amount of Methotrexate Excreted in the Urine	Day 15
7-Hydroxymethotrexate (7-OH-MTX) Maximum Plasma Concentration	Day 15	7-OH-MTX is the primary metabolite of methotrexate.
Time to Reach Maximum Plasma Concentration of 7-OH-MTX	Day 15
Amount of 7-OH-MTX Excreted in the Urine	Day 15

Secondary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration of LX3305 in the Presence of MTX	Day 15
Time to Maximum Plasma Concentration of LX3305 in the Presence of MTX	Day 15
Half-life of LX3305 in Plasma in the Presence of MTX	Day 15
Percentage of Change From Baseline in Absolute Total Lymphocyte Count at Day 15	Day 15	Baseline was defined as pre-dose on Day 1.

Trial Locations

Locations (1)

Metroplex Clinical Research Center; 🇺🇸 Dallas, Texas, United States