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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00370435
Recruitment Status : Completed
First Posted : August 31, 2006
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: GW274150 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2005
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Liver function and creatinine clearance after single 90mg dose of GW274150

Secondary Outcome Measures :
  1. clinical laboratory tests assessment of adverse events ECGs vital signs and Pharmacokinetic data of elderly population

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00370435

United Kingdom
GSK Investigational Site
London, United Kingdom, W6 8LH
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT00370435     History of Changes
Other Study ID Numbers: 104916
First Posted: August 31, 2006    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by GlaxoSmithKline:
rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases