search
Back to results

Study Of 90mg Of GW274150 In Subjects Over 50 Years, Who Have Rheumatoid Arthritis (RA)

Primary Purpose

Arthritis, Rheumatoid

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
GW274150
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring rheumatoid arthritis, safety, GW274150, pharmacokinetics, tolerability

Eligibility Criteria

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

Inclusion criteria: No clinically significant disease as determined by history, physical examination and screening investigations. RA subjects on methotrexate (7.5mg - 25mg per week) Body weight >50 kg for males and >45 kg for females, who are not morbidly obese Diagnosis of RA Active disease defined as DAS28 = 4.0 and at least one MCP joint with either detectable vascularity or thickness Stable doses of DMARDs (Disease-modifying anti-rheumatic drugs, which must include methotrexate and can also include but is not restricted to sulphasalazine and hydroxychloroquine in any combination) for 8 weeks prior to enrolment Must be on stable folate supplements Subjects using NSAIDs or Cox-2 inhibitors must have been on stable doses for 2 weeks prior to screening LFT functions (ALT, AST, ALP) = 1.5 x ULN at screening and which have been stable on at least 2 occasions in the 7 months prior to screening Must provide signed and dated written informed consent prior to admission to the study Ability to understand and comply with protocol requirements, instructions and protocol-stated restrictions. Exclusion criteria: Past or present disease, which as judged by the investigator, may affect the outcome of this study. Clinically significant abnormalities in safety laboratory analysis at screening Pregnant or nursing women Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception as outlined As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the subject unfit for the study Taking >10mg/day oral glucocorticoids Currently receiving anti-rheumatic biological therapy Received their final dose of infliximab or adalimumab within 3 months of enrollment Received their final dose of etanercept or anakinra within 1 month of enrollment Has received an investigational drug or participated in any other NCE research trial within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to enrol.ment Regularly drinks more than 28 units of alcohol in a week if male, or 21 units per week if female. Has a screening QTc value of >430msec (males) or >450msec (females), PR interval outside the range 120 to 200msec or an ECG that is not suitable for QT measurements History of liver or renal disease in the 6 months prior to screening Current renal insufficiency (subject must have an estimated creatinine clearance less than50mL/min as estimated from the serum creatinine using the Cockroft-Gault formula Has donated a unit of blood within the previous month or intends to donate in the month after completing the study Has a history or drug or other allergy, which in the opinion of the physician responsible, contraindicates their participation History of, or risk factors for, HIV, Hepatitis B and Hepatitis C History of drug abuse

Sites / Locations

  • GSK Investigational Site

Outcomes

Primary Outcome Measures

Liver function and creatinine clearance after single 90mg dose of GW274150

Secondary Outcome Measures

clinical laboratory tests assessment of adverse events ECGs vital signs and Pharmacokinetic data of elderly population

Full Information

First Posted
August 17, 2006
Last Updated
May 25, 2017
Sponsor
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00370435
Brief Title
Study Of 90mg Of GW274150 In Subjects Over 50 Years, Who Have Rheumatoid Arthritis (RA)
Official Title
An Open-label, Single Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of 90mg of GW274150 in Adult and Elderly RA Subjects.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
This is a study of GW274150, an iNOS (inducible nitric oxide synthase) inhibitor to investigate safety, tolerability and pharmacokinetics (PK) in the rheumatoid arthritis (RA) population (greater than 50 years). Safety, tolerability and PK of GW274150 in an adult and elderly population have not yet been determined. Therefore this study is designed to ensure that 90mg GW274150 will be safe and well-tolerated in this adult and elderly RA patient population on methotrexate. The assessments will include pharmacokinetics (PK), liver function tests and creatinine clearance. This study will provide confidence that a single 90mg dose of GW274150 results in exposure in RA subjects similar to that expected from healthy volunteers and asthmatics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
rheumatoid arthritis, safety, GW274150, pharmacokinetics, tolerability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GW274150
Primary Outcome Measure Information:
Title
Liver function and creatinine clearance after single 90mg dose of GW274150
Secondary Outcome Measure Information:
Title
clinical laboratory tests assessment of adverse events ECGs vital signs and Pharmacokinetic data of elderly population

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: No clinically significant disease as determined by history, physical examination and screening investigations. RA subjects on methotrexate (7.5mg - 25mg per week) Body weight >50 kg for males and >45 kg for females, who are not morbidly obese Diagnosis of RA Active disease defined as DAS28 = 4.0 and at least one MCP joint with either detectable vascularity or thickness Stable doses of DMARDs (Disease-modifying anti-rheumatic drugs, which must include methotrexate and can also include but is not restricted to sulphasalazine and hydroxychloroquine in any combination) for 8 weeks prior to enrolment Must be on stable folate supplements Subjects using NSAIDs or Cox-2 inhibitors must have been on stable doses for 2 weeks prior to screening LFT functions (ALT, AST, ALP) = 1.5 x ULN at screening and which have been stable on at least 2 occasions in the 7 months prior to screening Must provide signed and dated written informed consent prior to admission to the study Ability to understand and comply with protocol requirements, instructions and protocol-stated restrictions. Exclusion criteria: Past or present disease, which as judged by the investigator, may affect the outcome of this study. Clinically significant abnormalities in safety laboratory analysis at screening Pregnant or nursing women Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception as outlined As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the subject unfit for the study Taking >10mg/day oral glucocorticoids Currently receiving anti-rheumatic biological therapy Received their final dose of infliximab or adalimumab within 3 months of enrollment Received their final dose of etanercept or anakinra within 1 month of enrollment Has received an investigational drug or participated in any other NCE research trial within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to enrol.ment Regularly drinks more than 28 units of alcohol in a week if male, or 21 units per week if female. Has a screening QTc value of >430msec (males) or >450msec (females), PR interval outside the range 120 to 200msec or an ECG that is not suitable for QT measurements History of liver or renal disease in the 6 months prior to screening Current renal insufficiency (subject must have an estimated creatinine clearance less than50mL/min as estimated from the serum creatinine using the Cockroft-Gault formula Has donated a unit of blood within the previous month or intends to donate in the month after completing the study Has a history or drug or other allergy, which in the opinion of the physician responsible, contraindicates their participation History of, or risk factors for, HIV, Hepatitis B and Hepatitis C History of drug abuse
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
London
ZIP/Postal Code
W6 8LH
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Study Of 90mg Of GW274150 In Subjects Over 50 Years, Who Have Rheumatoid Arthritis (RA)

We'll reach out to this number within 24 hrs