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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00370435
First received: August 17, 2006
Last updated: January 19, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Arthritis, Rheumatoid
Drug: GW274150
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

Enrollment: 6
Study Start Date: August 2005
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GW274150
    Other Name: GW274150
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370435

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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00370435     History of Changes
Other Study ID Numbers: 104916
Study First Received: August 17, 2006
Last Updated: January 19, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
rheumatoid arthritis
safety
GW274150
pharmacokinetics
tolerability

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

ClinicalTrials.gov processed this record on July 20, 2014