SB-681323-Methotrexate Interaction Study

NCT ID: NCT00419809

Last Updated: 2012-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2005-12-31

Brief Summary

SB-681323 is a p38 MAP-kinase inhibitor that has potential uses in inflammatory conditions such as RA. Previous p38 MAP-kinase inhibitors have been hindered in development by liver toxicity. Methotrexate (common treatment for RA patients) also has potential liver toxicity. This study was an enabling study to determine the safety of co-administration of the two compounds with respect to liver function

Conditions

Arthritis, Rheumatoid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

SB-681323 oral tablets

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female. Females must be of non-child-bearing capacity
• BMI 19 - 30 kg/m2 (inclusive)
• Diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology (ACR)
• Negative urine drugs of abuse screen, breath alcohol tests, hepatitis B and C, and HIV tests.
• Liver function tests within normal limits
• Must be on a stable dose of methotrexate (2.5 - 25 mg/week) for >8 weeks prior to enrolment and which will not be changed during the course of this study.
• Must be on stable folate supplements for >8 weeks prior to enrolment with normal red cell folate levels at enrollment.

Exclusion Criteria

• History of alcohol &/or drug abuse
• Abnormal ECGs at screening
• Liver disease, uncontrolled hypertension, diabetes mellitus, psoriasis, history of peptic ulcer disease
• The patient is using glucocorticoid at doses >10mg/day.
• The patient is using sulphasalazine at a dose >3g/day.
• The patient is using hydroxychloroquine at a dose >400mg/day.
• The patient is on treatment regimen of DMARDs other than MTX plus one or both of sulphasalazine and hydrochloroquine (e.g. leflunomide)
• The patient dose of NSAIDs, COX-2 inhibitors or glucocorticoids change at any time during 2 weeks prior to enrolment until the end of the clinical phase of the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Randwick, Sydney, New South Wales, Australia

GSK Investigational Site

Adelaide, , Australia

Countries

Australia

Other Identifiers

RA1101607

Identifier Type: -

Identifier Source: org_study_id