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

Phase 2

Completed

• Conditions: Arthritis, Rheumatoid

• Registration Number: NCT00370435
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Study First Submitted: 2006-08-17
• Study First Submitted QC: 2006-08-29
• Study First Posted: 2006-08-31
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 London, United Kingdom