Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00359463
Status:
COMPLETED
Last Update Posted:
2017-11-13
First Post:
2006-07-28
Brief Title:
Study Of Eltrombopag in Healthy Subjects and Volunteers With Mild Moderate or Severe Hepatic Impairment
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
An Open-Label Non-Randomized Pharmacokinetic and Safety Study of a Single Oral Dose of 50mg Eltrombopag in Healthy Subjects and in Volunteers With Mild Moderate or Severe Hepatic Impairment
Status:
COMPLETED
Status Verified Date:
2017-11
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:
The main purpose of this study is to compare how one 50mg tablet of SB-497115 is broken down in the body by healthy subjects versus subjects with mild moderate or severe liver problems The study is also being done to 1 check on how well the study drug is tolerated by healthy subjects versus those with liver problems and 2 to check if liver impairment affects how the study drug binds to protein in the blood
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