NCT00847886

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_1 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 3, 2010

Completed
Last Updated

June 3, 2010

Status Verified

June 1, 2010

Enrollment Period

28 days

First QC Date

February 17, 2009

Results QC Date

April 19, 2010

Last Update Submit

June 1, 2010

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (7)

  • Methotrexate Maximum Plasma Concentration

    Day 15

  • Time to Reach Maximum Plasma Concentration of Methotrexate

    Day 15

  • Half-life of Methotrexate in Plasma

    Day 15

  • Amount of Methotrexate Excreted in the Urine

    Day 15

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

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

    Day 15

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

    Day 15

  • Amount of 7-OH-MTX Excreted in the Urine

    Day 15

Secondary Outcomes (4)

  • Maximum Plasma Concentration of LX3305 in the Presence of MTX

    Day 15

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

    Day 15

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

    Day 15

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

    Day 15

Study Arms (2)

LX3305

EXPERIMENTAL

Daily oral intake of LX3305 for 14 days.

Drug: LX3305Drug: Methotrexate

LX3305 Placebo

PLACEBO COMPARATOR

Matching placebo dosing with daily oral intake for 14 days.

Drug: LX3305 PlaceboDrug: Methotrexate

Interventions

LX3305DRUG

Daily oral intake of LX3305 for 14 days.

LX3305
LX3305 PlaceboDRUG

Matching placebo dosing with daily oral intake for 14 days.

LX3305 Placebo
MethotrexateDRUG

Once weekly stable-dose methotrexate.

LX3305LX3305 Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Metroplex Clinical Research Center

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Joel P. Freiman, MD, MPH - Medical Director, Drug Safety
Organization
Lexicon Pharmaceuticals, Inc.
281-863-3000

Study Officials

  • Philip M. Brown, MD, JD

    Lexicon Pharmaceuticals, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 17, 2009

First Posted

February 19, 2009

Study Start

February 1, 2009

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

June 3, 2010

Results First Posted

June 3, 2010

Record last verified: 2010-06

Locations

US(1)