Three-way-cross-over Study to Evaluate Safety and Pharmacokinetics of Lacosamide in Healthy Japanese and Chinese Males

A Phase I, Randomized Double-blind, Placebo-controlled, Single-center, Single-dose, Three-way Cross-over Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Lacosamide Tablets in Healthy Male Chinese and Japanese Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01375387

Enrollment

Registered

2011-06-17

Start date

2011-03-31

Completion date

2011-06-30

Last updated

2011-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Vimpat, Pharmacokinetics, Healthy Japanese male, Healthy Chinese male

Brief summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of lacosamide following single oral administration of lacosamide 100 mg, 200 mg and 400 mg in healthy male Chinese and Japanese subjects.

Interventions

DRUGLacosamide

100 mg oral tablet, single dose

OTHERPlacebo 3

Placebo - 3 tablets

OTHERPlacebo 4

Placebo - 4 tablets

OTHERPlacebo 2

Placebo - 2 tablets

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy Chinese or Japanese volunteers

Exclusion criteria

* Subject has participated or is participating in any other clinical studies of Lacosamide within the last 3 months * Subject is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes or caffeine, having any psychological or emotional problems, a drug/alcohol abuse, abnormal diet, having abnormal safety parameters)

Design outcomes

Primary

Measure	Time frame
Maximum drug concentration (Cmax) of lacosamide in plasma.	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Area under the curve from 0 to the time of the last quantifiable concentration (AUC(0-t)) of lacosamide in plasma	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Area under the curve from 0 to infinity (AUC) of lacosamide in plasma	Multiple sampling from 0 to 72 hours following single dose in each treatment period

Secondary

Measure	Time frame
Apparent volume of distribution (Vz/F) of lacosamide in plasma	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Mean resident time (MRT) of lacosamide in plasma.	Multiple sampling from 0 to 72 hours following single dose in each treatment period
First order terminal elimination rate constant (λZ ) of lacosamide in plasma	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Maximum drug concentration (Cmax) of SPM12809 in plasma.	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Area under the curve from 0 to the time of the last quantifiable concentration (AUC(0-t)) of SPM12809 in plasma	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Area under the curve from 0 to infinity (AUC) of SPM12809 in plasma	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Time to reach maximum plasma concentration (tmax) of SPM12809 in plasma	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Time to reach maximum plasma concentration (tmax) of lacosamide in plasma	Multiple sampling from 0 to 72 hours following single dose in each treatment period
First order terminal elimination rate constant (λZ ) of SPM12809 in plasma	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Total amount of drug excreted in urine (Ae) of lacosamide and SPM12809	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Fraction of dose excreted in urine (fe) of lacosamide and SPM12809	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Renal clearance (CLR) of lacosamide and SPM12809	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Apparent formation clearance of metabolites (CLfm/F)	Multiple sampling from 0 to 72 hours following single dose in each treatment period
AUC Ratio	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Terminal half-life (t½) of SPM12809 in plasma	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Terminal half-life (t½) of lacosamide in plasma	Multiple sampling from 0 to 72 hours following single dose in each treatment period
Apparent total body clearance (CL/F) of lacosamide in plasma	Multiple sampling from 0 to 72 hours following single dose in each treatment period

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026