Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370435
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2006-08-17
Brief Title:
Study Of 90mg Of GW274150 In Subjects Over 50 Years Who Have Rheumatoid Arthritis RA
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None