Study of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis - Full Text View

Sponsored by:	Lexicon Pharmaceuticals
Information provided by:	Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00847886

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: Placebo	Phase I

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Lexicon Pharmaceuticals:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	18
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
LX3305: Experimental Daily oral intake of LX3305 for 14 days.	Drug: LX3305 Daily oral intake of LX3305 for 14 days.
Placebo: Placebo Comparator Matching placebo dosing with daily oral intake for 14 days.	Drug: Placebo Matching placebo dosing with daily oral intake for 14 days.

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

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:	Lexicon Pharmaceuticals, Inc. ( S. Chris Pappas, MD, JD (Senior Director, Clinical Research) )
Study ID Numbers:	Protocol LX3305.1-104-DDI, LX3305.104, LX2931
Study First Received:	February 17, 2009
Last Updated:	April 23, 2009
ClinicalTrials.gov Identifier:	NCT00847886 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Autoimmune Diseases
Immunologic Factors
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Folic Acid Antagonists

Immunosuppressive Agents
Folic Acid
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases
Methotrexate
Antirheumatic Agents

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Arthritis, Rheumatoid
Reproductive Control Agents
Musculoskeletal Diseases
Arthritis
Therapeutic Uses
Abortifacient Agents
Connective Tissue Diseases

Methotrexate
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Autoimmune Diseases
Immune System Diseases
Joint Diseases
Enzyme Inhibitors
Rheumatic Diseases
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 07, 2009