MedTrace Logo

Evaluation of Pharmacokinetics, Safety and Tolerability of Single and Multiple Oral Doses of Neramexane Mesylate in Healthy Japanese Subjects

NCT00983099 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2011-04-15

No results posted yet for this study

Summary

Part 1 (single dose)

Primary parameters

* Area under the plasma concentration curve from zero to infinity \[AUC0-inf\] and observed maximum plasma concentration \[Cmax\] of Japanese and Caucasian subjects for each dose group
* If at least 20% of the Japanese or of the Caucasian subjects have an area under the plasma concentration curve extrapolation \[AUCextrap%\] \>20% relative to AUC0-inf for one of the dose groups area under the plasma concentration curve from zero to the last measurable concentration \[AUC0- tz\] becomes primary parameter for Japanese and Caucasian subjects for all of the dose groups. In this case AUC0-tau will become a secondary parameter

Secondary parameters and derived values from statistical analysis

* Dose proportionality and linearity in Japanese subjects
* Ratios (Japanese vs. Caucasian subjects) of AUC0-∞ and Cmax for each dose group
* Dose normalized AUC \[AUC0-inf,norm\], dose normalized Cmax \[Cmax,norm\], AUC0- tz, time of occurrence of Cmax \[tmax\], apparent terminal half life \[t½\], mean residence time \[MRT\], apparent (oral) total plasma clearance \[CLtot/f\], apparent volume of distribution during the terminal disposition phase \[Vz/f\], AUCextrap%, apparent terminal disposition rate constant \[λz\], weight corrected AUC0-inf, weight corrected AUC0-tz, weight corrected Cmax, weight corrected CLtot/f, cumulative amount of excreted Neramexane into urine \[Ae0-tz\], fraction of orally administrated drug excreted into urine \[fe/f\], renal clearance \[CLR\] and apparent non-renal clearance \[CLNR/f\]
* Safety and tolerability

Other parameters

* Pharmacogenetics
* Amount of N-OH Neramexane excreted in urine \[Ae0-tz\] if a validated method will be available at the time of analysis
* Metabolite determination (N-OH Neramexane) in plasma and urine, optional (may be analyzed and evaluated if a validated method will be available at the time of analysis)
* Endogenous creatinine clearance \[CLCR\], amount of excreted creatinine into urine per hour \[AeCR,hr\]
* Evaluation of further metabolites will be described in detail in the Statistical Analysis Plan

Conditions

  • Healthy

Interventions

DRUG

Neramexane

single and multiple dose, tablets, oral

Sponsors & Collaborators

  • Merz Pharmaceuticals GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • United States

Study Locations

More Related Trials

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 NCT00983099 on ClinicalTrials.gov