A Pharmacokinetic, Pharmacodynamic, Safety Study With AOP LDLA202, ONO LDL50 and Esmolol in Healthy Volunteers

Phase 1 Completed 12 enrolled AOP Orphan Pharmaceuticals AG

RandomizedCrossoverQuadruple-blindTreatment

Summary

The study consists of a Pilot Phase (to assess safety and the local tolerability of highest AOP LDLA202 dose versus placebo) and a Main Treatment Phase (to compare PK, PD and safety and tolerability of AOP LDLA202, ONO LDL50 and esmolol bolus administrations by measurement of blood concentrations of landiolol, esmolol and their metabolites, and by monitoring ECG, blood pressure and adverse events).

Timeline

Start: 2012-07
Primary completion: 2012-07
Completion: 2012-08

Publications

Krumpl G, Ulc I, Trebs M, Kadlecova P, Hodisch J. Bolus application of landiolol and esmolol: comparison of the pharmacokinetic and pharmacodynamic profiles in a healthy Caucasian group. Eur J Clin Pharmacol. 2017 Apr;73(4):417-428. doi: 10.1007/s00228-016-2176-0. Epub 2017 Jan 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Esmolol	Other / unclassified	0.5 mg/kg	Intravenous
Comparator	Esmolol	Other / unclassified	1 mg/kg	Intravenous
Comparator	Esmolol	Other / unclassified	1.5 mg/kg	Intravenous
Subject	LDLA202	Unknown	0.1 mg/kg	Intravenous
Subject	LDLA202	Unknown	0.2 mg/kg	Intravenous
Subject	LDLA202	Unknown	0.3 mg/kg	Intravenous
Comparator	ONO LDL50	Unknown	0.1 mg/kg	Intravenous
Comparator	ONO LDL50	Unknown	0.2 mg/kg	Intravenous
Comparator	ONO LDL50	Unknown	0.3 mg/kg	Intravenous

Indications

No indication recorded.