Ignite Creation Date:
2024-05-05 @ 9:54 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00986895
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2009-09-15
Brief Title:
A Study of Glyceryl Tri-4-phenylbutyrate Administered Orally as a Single Dose and Twice Daily for Seven Consecutive Days to Subjects With Hepatic Impairment With Cirrhosis and to a Control Group
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2024-06
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 purpose of this study is to determine the safety and tolerability of GT4P administered orally as a single dose and twice daily for 7 consecutive days to subjects with hepatic impairment with cirrhosis Child-Pugh scores of A B or C and to a gender matched and similar age control group with normal hepatic function
Detailed Description:
Study acquired from Horizon in 2024
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