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Study of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

LX3305

LX3305 Placebo

Methotrexate

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Metroplex Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LX3305

LX3305 Placebo

Arm Description

Daily oral intake of LX3305 for 14 days.

Matching placebo dosing with daily oral intake for 14 days.

Outcomes

Primary Outcome Measures

Methotrexate Maximum Plasma Concentration

Time to Reach Maximum Plasma Concentration of Methotrexate

Half-life of Methotrexate in Plasma

Amount of Methotrexate Excreted in the Urine

7-Hydroxymethotrexate (7-OH-MTX) Maximum Plasma Concentration

7-OH-MTX is the primary metabolite of methotrexate.

Time to Reach Maximum Plasma Concentration of 7-OH-MTX

Amount of 7-OH-MTX Excreted in the Urine

Secondary Outcome Measures

Maximum Plasma Concentration of LX3305 in the Presence of MTX

Time to Maximum Plasma Concentration of LX3305 in the Presence of MTX

Half-life of LX3305 in Plasma in the Presence of MTX

Percentage of Change From Baseline in Absolute Total Lymphocyte Count at Day 15

Baseline was defined as pre-dose on Day 1.

Full Information

NCT ID

NCT00847886

First Posted

February 17, 2009

Last Updated

June 1, 2010

Sponsor

Lexicon Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00847886

Brief Title

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

2. Study Status

Record Verification Date

June 2010

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Lexicon Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LX3305

Arm Type

Experimental

Arm Description

Daily oral intake of LX3305 for 14 days.

Arm Title

LX3305 Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo dosing with daily oral intake for 14 days.

Intervention Type

Drug

Intervention Name(s)

LX3305

Intervention Description

Daily oral intake of LX3305 for 14 days.

Intervention Type

Drug

Intervention Name(s)

LX3305 Placebo

Intervention Description

Matching placebo dosing with daily oral intake for 14 days.

Intervention Type

Drug

Intervention Name(s)

Methotrexate

Intervention Description

Once weekly stable-dose methotrexate.

Primary Outcome Measure Information:

Title

Methotrexate Maximum Plasma Concentration

Time Frame

Day 15

Title

Time to Reach Maximum Plasma Concentration of Methotrexate

Time Frame

Day 15

Title

Half-life of Methotrexate in Plasma

Time Frame

Day 15

Title

Amount of Methotrexate Excreted in the Urine

Time Frame

Day 15

Title

7-Hydroxymethotrexate (7-OH-MTX) Maximum Plasma Concentration

Description

7-OH-MTX is the primary metabolite of methotrexate.

Time Frame

Day 15

Title

Time to Reach Maximum Plasma Concentration of 7-OH-MTX

Time Frame

Day 15

Title

Amount of 7-OH-MTX Excreted in the Urine

Time Frame

Day 15

Secondary Outcome Measure Information:

Title

Maximum Plasma Concentration of LX3305 in the Presence of MTX

Time Frame

Day 15

Title

Time to Maximum Plasma Concentration of LX3305 in the Presence of MTX

Time Frame

Day 15

Title

Half-life of LX3305 in Plasma in the Presence of MTX

Time Frame

Day 15

Title

Percentage of Change From Baseline in Absolute Total Lymphocyte Count at Day 15

Description

Baseline was defined as pre-dose on Day 1.

Time Frame

Day 15

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philip M. Brown, MD, JD

Organizational Affiliation

Lexicon Pharmaceuticals, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Metroplex Clinical Research Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

12. IPD Sharing Statement

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Study of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis

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