Study of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis

Lexicon Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: LX3305 Placebo; Drug: LX3305; Drug: Methotrexate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00847886

Protocol LX3305.1-104-DDI

LX2931

LX3305.104

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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15 participants in 2 patient groups, including a placebo group

LX3305

Experimental group

Description:

Daily oral intake of LX3305 for 14 days.

Treatment:

Drug: Methotrexate

Drug: LX3305

LX3305 Placebo

Placebo Comparator group

Description:

Matching placebo dosing with daily oral intake for 14 days.

Treatment:

Drug: LX3305 Placebo

Drug: Methotrexate