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Completed

NCT Number: NCT00847886

Study of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Metroplex Clinical Research Center

Dallas, Texas, 75235, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LX3305

Drug

Daily oral intake of LX3305 for 14 days.

LX3305 Placebo

Drug

Matching placebo dosing with daily oral intake for 14 days.

methotrexate

Drug

Once weekly stable-dose methotrexate.

Primary outcomes

  1. Methotrexate Maximum Plasma Concentration

    Time frame: Day 15

  2. Time to Reach Maximum Plasma Concentration of Methotrexate

    Time frame: Day 15

  3. Half-life of Methotrexate in Plasma

    Time frame: Day 15

  4. Amount of Methotrexate Excreted in the Urine

    Time frame: Day 15

  5. 7-Hydroxymethotrexate (7-OH-MTX) Maximum Plasma Concentration

    Time frame: Day 15

    7-OH-MTX is the primary metabolite of methotrexate.

  6. Time to Reach Maximum Plasma Concentration of 7-OH-MTX

    Time frame: Day 15

  7. Amount of 7-OH-MTX Excreted in the Urine

    Time frame: Day 15

Secondary outcomes

  1. Maximum Plasma Concentration of LX3305 in the Presence of MTX

    Time frame: Day 15

  2. Time to Maximum Plasma Concentration of LX3305 in the Presence of MTX

    Time frame: Day 15

  3. Half-life of LX3305 in Plasma in the Presence of MTX

    Time frame: Day 15

  4. Percentage of Change From Baseline in Absolute Total Lymphocyte Count at Day 15

    Time frame: Day 15

    Baseline was defined as pre-dose on Day 1.

Sponsors and collaborators

Lead sponsor

Lexicon Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 19, 2009
Registry last updated
Jun 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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