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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Lacosamide
* Drug: Lacosamide
* Drug: Lacosamide
* Other: Placebo 3
* Other: Placebo 4
* Other: Placebo 2


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lacosamide 100 mg, Japanese<br>1 Lacosamide 100 mg tablet plus 3 placebo tablets | Drug: Lacosamide<br>* 100 mg oral tablet, single dose<br>* Other names: Vimpat®;Other: Placebo 3<br>* Placebo - 3 tablets<br>|
| Experimental: Lacosamide 100 mg, Chinese<br>1 Lacosamide 100 mg tablet plus 3 placebo tablets | Drug: Lacosamide<br>* 100 mg oral tablet, single dose<br>* Other names: Vimpat®;Other: Placebo 3<br>* Placebo - 3 tablets<br>|
| Experimental: Lacosamide 200 mg, Japanese<br>2 Lacosamide 100 mg tablets plus 2 placebo tablets | Drug: Lacosamide<br>* Lacosamide 2 X 100 mg tablet<br>* Other names: Vimpat®;Other: Placebo 2<br>* Placebo - 2 tablets<br>|
| Experimental: Lacosamide 200 mg, Chinese<br>2 Lacosamide 100 mg tablets plus 2 placebo tablets | Drug: Lacosamide<br>* Lacosamide 2 X 100 mg tablet<br>* Other names: Vimpat®;Other: Placebo 2<br>* Placebo - 2 tablets<br>|
| Experimental: Lacosamide 400 mg, Japanese<br>4 Lacosamide 100 mg tablets | Drug: Lacosamide<br>* Lacosamide 4 X 100mg tablet<br>* Other names: Vimpat®;|
| Experimental: Lacosamide 400 mg, Chinese<br>4 Lacosamide 100 mg tablets | Drug: Lacosamide<br>* Lacosamide 4 X 100mg tablet<br>* Other names: Vimpat®;|
| Placebo Comparator: Placebo Comparator, Japanese<br>4 placebo tablets | Other: Placebo 4<br>* Placebo - 4 tablets<br>|
| Placebo Comparator: Placebo Comparator, Chinese<br>4 placebo tablets | Other: Placebo 4<br>* Placebo - 4 tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Terminal half-life (t½) of SPM12809 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vimpat, Pharmacokinetics, Healthy Japanese male, Healthy Chinese male