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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

NCT00978614 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2011-02-15

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Merz Pharmaceuticals GmbH

    lead INDUSTRY

Study Design

Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00978614 on ClinicalTrials.gov