NCT00978614

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

Valuation of Dose-Dependent Repeated-Dose Neramexane Effects on Cardiac Repolarisation (QT/QTc Interval Duration) Randomized, Double-Blind, Placebo- and Moxifloxacin-Controlled, Ascending Repeated-Dose, Three-Arm Parallel Design ECG Study in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Merz Pharmaceuticals GmbH · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Neramexane	Dosage form: 25 mg immediate release \[IR\] tablets (=15.9 mg neramexane free base) 37.5 mg IR tablets (=23.9 mg neramexane free base)

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2009-09-17
• Last updated: 2011-02-15

Locations

1 site across 1 country: Germany