Ignite Creation Date:
2024-05-05 @ 9:49 PM
Last Modification Date:
2024-10-26 @ 10:10 AM
Study NCT ID:
NCT00977600
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2009-09-15
Brief Title:
A Study of Glyceryl Tri-4-phenylbutyrate GT4P
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Randomized Crossover Open-label Phase 1 Study of Glyceryl Tri-4-phenylbutyrate GT4P
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:
To determine the safety and tolerability of single oral doses of HPN-100 as a formulation GT4P-F and GT4P as the active pharmaceutical ingredient GT4P-API administered to healthy male subjects
Detailed Description:
A randomized open-label four-treatment four-period crossover study in which healthy male subjects received a single dose of each of the following four treatments on four separate dosing days 7 days apart
Oral sodium phenylbutyrate Buphenyl equivalent to 3 gm2 of 4-phenylbutyric acid PBA per dose
Oral GT4P-F mole equivalents to 3 gm2 of PBA per dose
Oral GT4P-API mole equivalents to 3 gm2 of PBA per dose
Intravenous 10 sodium phenylacetate plus 10 sodium benzoate Ammonul 275 gm2
Study acquired from Horizon in 2024
Oral sodium phenylbutyrate Buphenyl equivalent to 3 gm2 of 4-phenylbutyric acid PBA per dose
Oral GT4P-F mole equivalents to 3 gm2 of PBA per dose
Oral GT4P-API mole equivalents to 3 gm2 of PBA per dose
Intravenous 10 sodium phenylacetate plus 10 sodium benzoate Ammonul 275 gm2
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