Healthy Subjects Clinical Trial
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
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.
n/a
Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver)
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