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
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: LX3305
Drug: LX3305 Placebo
Drug: Methotrexate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Lexicon Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 15
Study Start Date: February 2009
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LX3305
Daily oral intake of LX3305 for 14 days.
Drug: LX3305
Daily oral intake of LX3305 for 14 days.
Drug: Methotrexate
Once weekly stable-dose methotrexate.
Placebo Comparator: LX3305 Placebo
Matching placebo dosing with daily oral intake for 14 days.
Drug: LX3305 Placebo
Matching placebo dosing with daily oral intake for 14 days.
Drug: Methotrexate
Once weekly stable-dose methotrexate.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00847886

Locations
United States, Texas
Metroplex Clinical Research Center
Dallas, Texas, United States, 75235
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
Study Director: Philip M. Brown, MD, JD Lexicon Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Joel P. Freiman, MD, MPH (Medical Director, Drug Safety), Lexicon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00847886     History of Changes
Other Study ID Numbers: Protocol LX3305.1-104-DDI, LX3305.104, LX2931
Study First Received: February 17, 2009
Results First Received: April 19, 2010
Last Updated: June 1, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 29, 2014