Evaluation of Dose-Dependent Repeated-Dose Neramexane Effects on Cardiac Repolarisation (QT/QTc Interval Duration): Electrocardiogram (ECG) Study in Healthy Adult Subjects

Summary

Primary: * To assess the effects of ascending repeated-doses of oral \[p.o.\] neramexane at therapeutic and supra-therapeutic steady-state doses on cardiac repolarisation (QT/QTc interval) in healthy male and female subjects. Secondary: * To assess the pharmacokinetics \[PK\] of neramexane and N-OH neramexane (if a validated method will be available for this metabolite) following repeated daily doses of 50 mg (steady state), 75 mg (steady state) and 87.5 mg (steady state). * To assess the safety and tolerability of neramexane 50 mg, 62.5 mg, 75 mg and 87.5 mg repeated-dose treatments when gradually up-titrated in healthy subjects. * To assess the concentration-QT relationship.

Timeline

Start

2009-09

Primary completion

2010-04

Completion

2010-04

Drugs

Indications

No indication recorded.