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

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:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Methotrexate sodium

U.S. FDA Resources

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

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 May 23, 2013