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NCT00983099 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Pharmacokinetics, Safety and Tolerability of Single and Multiple Oral Doses of Neramexane Mesylate in Healthy Japanese Subjects
A Phase 1 study, sponsored by Merz Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT00983099 is a Phase 1 study that has completed, run by Merz Pharmaceuticals. The registered enrollment target is 56 participants.
The verdict
NCT00983099, a Phase 1 study, has completed, sponsored by Merz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
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
Interventions
- DRUG Neramexane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2009-09 |
| Est. Completion | 2010-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00983099
The ClinicalTrials.gov registry entry for NCT00983099 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merz Pharmaceuticals, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Neramexane is the first listed.
NCT00983099 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00983099 about?
NCT00983099 is a clinical study titled "Evaluation of Pharmacokinetics, Safety and Tolerability of Single and Multiple Oral Doses of Neramexane Mesylate in Healthy Japanese Subjects". 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 ar...
What is the current status of trial NCT00983099?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2009-09. Estimated completion is 2010-09.
What interventions are being tested in trial NCT00983099?
The interventions under investigation include: Neramexane (DRUG).
Who is sponsoring clinical trial NCT00983099?
This trial is sponsored by Merz Pharmaceuticals, which has 17 total clinical trials registered on ClinicalTrials.gov.
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