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

2014-08-27 03:19:17 | BioPortfolio

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.

Study Design

Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver)

Conditions

Healthy Subjects

Intervention

Neramexane

Location

Parexel International GmbH
Berlin
Germany
14050

Status

Recruiting

Source

Merz Pharmaceuticals GmbH

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:17-0400

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