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Study of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00847886
First received: February 17, 2009
Last updated: June 1, 2010
Last verified: June 2010
History of Changes

February 17, 2009
June 1, 2010
February 2009
March 2009   (final data collection date for primary outcome measure)
  • Methotrexate Maximum Plasma Concentration [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Plasma Concentration of Methotrexate [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
  • Half-life of Methotrexate in Plasma [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
  • Amount of Methotrexate Excreted in the Urine [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
  • 7-Hydroxymethotrexate (7-OH-MTX) Maximum Plasma Concentration [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    7-OH-MTX is the primary metabolite of methotrexate.
  • Time to Reach Maximum Plasma Concentration of 7-OH-MTX [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
  • Amount of 7-OH-MTX Excreted in the Urine [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
To evaluate the safety (physical examinations, clinical laboratory tests, vital signs measurements, and ECGs) of LX3305 in combination with stable-dose MTX and to investigate the effects of LX3305 on MTX pharmacokinetics [ Time Frame: Standard safety measurements will occur throughout the study, either weekly or biweekly; pharmacokinetic assessments will occur after initial dose and end of study. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00847886 on ClinicalTrials.gov Archive Site
  • Maximum Plasma Concentration of LX3305 in the Presence of MTX [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
  • Time to Maximum Plasma Concentration of LX3305 in the Presence of MTX [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
  • Half-life of LX3305 in Plasma in the Presence of MTX [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
  • Percentage of Change From Baseline in Absolute Total Lymphocyte Count at Day 15 [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
    Baseline was defined as pre-dose on Day 1.
To assess the effect of LX3305 on lymphocyte count in subjects with rheumatoid arthritis on stable-dose methotrexate, and assess effects of MTX on LX3305 pharmacokinetics. [ Time Frame: Lymphocyte counts throughout the study; pharmacokinetic assessments will occur after initial dose and end of study. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • 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.
  • Experimental: LX3305
    Daily oral intake of LX3305 for 14 days.
    Interventions:
    • Drug: LX3305
    • Drug: Methotrexate
  • Placebo Comparator: LX3305 Placebo
    Matching placebo dosing with daily oral intake for 14 days.
    Interventions:
    • Drug: LX3305 Placebo
    • Drug: Methotrexate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00847886
Protocol LX3305.1-104-DDI, LX3305.104, LX2931
No
Joel P. Freiman, MD, MPH (Medical Director, Drug Safety), Lexicon Pharmaceuticals, Inc.
Lexicon Pharmaceuticals
Not Provided
Study Director: Philip M. Brown, MD, JD Lexicon Pharmaceuticals, Inc.
Lexicon Pharmaceuticals
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP