Evaluation of Dose-Dependent Repeated-Dose Neramexane Effects on Cardiac Repolarisation (QT/QTc Interval Duration): Electrocardiogram (ECG) Study in Healthy Adult Subjects
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|ClinicalTrials.gov Identifier: NCT00978614|
Recruitment Status : Completed
First Posted : September 17, 2009
Last Update Posted : February 15, 2011
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Subjects||Drug: Neramexane||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||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|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
|Experimental: Neramexane, Placebo, Moxifloxacin||
25 mg immediate release [IR] tablets (=15.9 mg neramexane free base)
37.5 mg IR tablets (=23.9 mg neramexane free base)
- 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. [ Time Frame: steady state, therapeutic dose ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00978614
|Parexel International GmbH|
|Berlin, Germany, 14050|