NCT01741519

Long-term PK and Safety/Tolerability Testing LDLL600 Against Esmolol in Healthy Volunteers

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: AOP Orphan Pharmaceuticals AG · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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 (MEDIUM)for 2 hours Dose level 3 (HIGH)for 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 (FU)for 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	LDLL600	Comparison of 3 different doses LDLL600 in long-term infusion. 54 PK samples, BP and ECG measurement time points, several local tolerability measurement time points.
DRUG	Brevibloc	Comparison of 3 different doses Esmolol in long-term infusion. 54 PK samples, BP and ECG measurement time points, several local tolerability measurement time points.

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2012-12-05
• Last updated: 2015-04-21

Locations

1 site across 1 country: Czechia