Clinical trial NCT00847886: Study of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-02-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Methotrexate Maximum Plasma Concentration
timeFrame: Day 15
measure: Time to Reach Maximum Plasma Concentration of Methotrexate
timeFrame: Day 15
measure: Half-life of Methotrexate in Plasma
timeFrame: Day 15
measure: Amount of Methotrexate Excreted in the Urine
timeFrame: Day 15
measure: 7-Hydroxymethotrexate (7-OH-MTX) Maximum Plasma Concentration
timeFrame: Day 15
measure: Time to Reach Maximum Plasma Concentration of 7-OH-MTX
timeFrame: Day 15
measure: Amount of 7-OH-MTX Excreted in the Urine
timeFrame: Day 15
Secondary outcomes:
measure: Maximum Plasma Concentration of LX3305 in the Presence of MTX
timeFrame: Day 15
measure: Time to Maximum Plasma Concentration of LX3305 in the Presence of MTX
timeFrame: Day 15
measure: Half-life of LX3305 in Plasma in the Presence of MTX
timeFrame: Day 15
measure: Percentage of Change From Baseline in Absolute Total Lymphocyte Count at Day 15
timeFrame: Day 15
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Philip M. Brown, MD, JD
role: STUDY_DIRECTOR
References: