Back to resultsSB-681323-Methotrexate Interaction Study
Primary Purpose
Arthritis, Rheumatoid
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
SB-681323 oral tablets
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring methotrexate,, SB-681323,, p38 MAP Kinase Inhibitor,, liver function, Rheumatoid Arthritis,
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
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
Outcomes
Primary Outcome Measures
The primary outcome measure is the values of liver function tests following dosing with methotrexate alone (Day 1) and methotrexate and SB-681323 or placebo (Day 15).
Secondary Outcome Measures
The other comparisons of interest is the pharmacokinetics of methotrexate when dosed alone (Day 1) relative to when dosed with SB681323 (Day 15) pharmacodynamics (effect of SB-681323 on CRP & IL-6 at Days 1, 8 and 15.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00419809
Brief Title
SB-681323-Methotrexate Interaction Study
Official Title
A Placebo Controlled Study to Evaluate the Safety and Tolerability of Repeat Doses of SB-681323 in Patients Receiving Methotrexate for Rheumatoid Arthritis.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
methotrexate,, SB-681323,, p38 MAP Kinase Inhibitor,, liver function, Rheumatoid Arthritis,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SB-681323 oral tablets
Primary Outcome Measure Information:
Title
The primary outcome measure is the values of liver function tests following dosing with methotrexate alone (Day 1) and methotrexate and SB-681323 or placebo (Day 15).
Secondary Outcome Measure Information:
Title
The other comparisons of interest is the pharmacokinetics of methotrexate when dosed alone (Day 1) relative to when dosed with SB681323 (Day 15) pharmacodynamics (effect of SB-681323 on CRP & IL-6 at Days 1, 8 and 15.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Randwick, Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
GSK Investigational Site
City
Adelaide
ZIP/Postal Code
South Australia 5000
Country
Australia
12. IPD Sharing Statement
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SB-681323-Methotrexate Interaction Study
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