Study of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847886
• Other study ID #: Protocol LX3305.1-104-DDI
• Secondary ID: LX3305.104LX2931
• Status: Completed
• Phase: Phase 1
• First received: February 17, 2009
• Last updated: June 1, 2010
• Start date: February 2009
• Est. completion date: March 2009

Study information

• Verified date: June 2010
• Source: Lexicon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• LX3305
Daily oral intake of LX3305 for 14 days.
• LX3305 Placebo
Matching placebo dosing with daily oral intake for 14 days.
• Methotrexate
Once weekly stable-dose methotrexate.

Locations

Country	Name	City	State
United States	Metroplex Clinical Research Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Lexicon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Methotrexate Maximum Plasma Concentration		Day 15	No
Primary	Time to Reach Maximum Plasma Concentration of Methotrexate		Day 15	No
Primary	Half-life of Methotrexate in Plasma		Day 15	No
Primary	Amount of Methotrexate Excreted in the Urine		Day 15	No
Primary	7-Hydroxymethotrexate (7-OH-MTX) Maximum Plasma Concentration	7-OH-MTX is the primary metabolite of methotrexate.	Day 15	No
Primary	Time to Reach Maximum Plasma Concentration of 7-OH-MTX		Day 15	No
Primary	Amount of 7-OH-MTX Excreted in the Urine		Day 15	No
Secondary	Maximum Plasma Concentration of LX3305 in the Presence of MTX		Day 15	No
Secondary	Time to Maximum Plasma Concentration of LX3305 in the Presence of MTX		Day 15	No
Secondary	Half-life of LX3305 in Plasma in the Presence of MTX		Day 15	No
Secondary	Percentage of Change From Baseline in Absolute Total Lymphocyte Count at Day 15	Baseline was defined as pre-dose on Day 1.	Day 15	No