Ignite Creation Date:
2024-05-05 @ 10:32 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01135680
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2010-05-31
Brief Title:
Double-Blind Randomized Crossover Trial to Access Electrocardiogram Effects of HPN-100
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
Double-Blind Randomized Placebo-Control Trial to Evaluate Electrocardiogram Effects of HPN-100 as Defined by Clinical and Supratherapeutic Dose in Healthy Men and Women
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:
Arm 1
Primary Objective
To determine the safety and tolerability of multiple ascending supratherapeutic doses of HPN-100
Arm 2
Primary Objective
To assess the effects of steady-state levels of HPN-100 metabolites 4 phenylbutyric acid PBA phenylacetic acid PAA and phenylacetylglutamine PAGN on 12-lead electrocardiogram ECG parameters in healthy male and female subjects with the primary endpoint being the time-matched change from baseline in the QT interval corrected for heart rate HR based on an individual correction method QTcI
Primary Objective
To determine the safety and tolerability of multiple ascending supratherapeutic doses of HPN-100
Arm 2
Primary Objective
To assess the effects of steady-state levels of HPN-100 metabolites 4 phenylbutyric acid PBA phenylacetic acid PAA and phenylacetylglutamine PAGN on 12-lead electrocardiogram ECG parameters in healthy male and female subjects with the primary endpoint being the time-matched change from baseline in the QT interval corrected for heart rate HR based on an individual correction method QTcI
Detailed Description:
Assess the effects of steady-state levels of HPN-100 metabolites 4-phenylbutryic acid PBA phenylacetic acid PAA and phenylacetylglutamine PAGN on 12-lead electrocardiogram ECG parameters in health male and female subjects with the primary endpoint being the time-matched change from baseline in the QT interval corrected for heart rateHR based on an individual correction method QTcl
Study acquired from Horizon in 2024
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