Ignite Creation Date:
2024-05-06 @ 1:08 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01741519
Status:
COMPLETED
Last Update Posted:
2015-04-21
First Post:
2012-12-03
Brief Title:
Long-term PK and SafetyTolerability Testing LDLL600 Against Esmolol in Healthy Volunteers
Sponsor:
AOP Orphan Pharmaceuticals AG
Organization:
AOP Orphan Pharmaceuticals AG
Study Overview
Official Title:
A Single Centre Prospective Randomized Double Blind Crossover Pharmacokinetic Safety and Tolerability Study to Compare Long-term Infusion Administration of LDLL600 Against Esmolol in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2015-04
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 study will compare the pharmacokinetics PK safety and tolerability of long-term infusion of lyophilized landiolol LDLL600 against esmolol Brevibloc by measurement of blood concentrations of landiolol esmolol and their metabolites and by monitoring systemic cardiovascular and local tolerability blood pressure BP ECG including heart rate HR and adverse events AEs
Detailed Description:
12 subjects will be administered LDLL600 and Brevibloc in a double-blind randomized cross-over setting PK systemic cardiovascular and local tolerability and safety of 24-hour long infusions of three dose levels of both Investigational Medicinal Products IMPs during each treatment period will be assessed
Each treatment period will consist of
Dose level 1 LOW for 2 hours h Dose level 2 MEDIUMfor 2 hours Dose level 3 HIGHfor 2 hours PK and tolerability observation at dose level 3 2 or 1 will be continued for 18 hours in order to end up with a total infusion period of 24 h Post-infusion follow-up FUfor 6 hours after infusion termination
The duration of the wash-out period between treatment periods will be at least two days Each subject if confirmed eligible will complete two treatment periods in total
In case of poor tolerability alternative dosing schemes will be followed
Each treatment period will consist of
Dose level 1 LOW for 2 hours h Dose level 2 MEDIUMfor 2 hours Dose level 3 HIGHfor 2 hours PK and tolerability observation at dose level 3 2 or 1 will be continued for 18 hours in order to end up with a total infusion period of 24 h Post-infusion follow-up FUfor 6 hours after infusion termination
The duration of the wash-out period between treatment periods will be at least two days Each subject if confirmed eligible will complete two treatment periods in total
In case of poor tolerability alternative dosing schemes will be followed
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