Bioavailability/Bioequivalence Study Between Lacosamide Tablet and Solution for Infusion in Healthy Japanese Subjects

Study Overview
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Brief Summary
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This study will be conducted to compare the pharmacokinetics of Lacosamide (LCM) following a single 30-minute or 60-minute iv infusion of LCM 200 mg with those following a single oral dose of LCM 200 mg in healthy Japanese subjects.

Official Title
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A Single Center Open-label, Randomized, Single-dose, 3-way Crossover Study to Compare the Safety, Tolerability, and Pharmacokinetics of Lacosamide Administered as Oral Tablet or Intravenous Infusion in Healthy Japanese Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Lacosamide infusion
* Drug: Lacosamide oral


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Japanese male and female volunteers with the age between 20 and 55 years old Exclusion Criteria: Subject has participated or is participating in any other clinical studies of investigational drug or another investigational medical product within the last 3 months Subject has a history (within 6 months) before screening visit of chronic alcohol and/or drug abuse and/or has smoked and/or has a history or presence of cardiovascular, respiratory, hepatic, renal, GI, endocrinological, or neurological disorders Subject has a history of suicide attempt or current active suicidal ideation Subject has experienced a myocardial infarction and/or made a blood donation or any other blood loss more than 400 ml in the last 3 months Subject is pregnant or nursing Subject is not healthy (eg, taking any drug treatments, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters and/or was positive for HIV, HBsAg, HCV) Subject has an excessive use of alcohol or/and cigarettes and/or caffeine and/or abnormal diet and/or has taken grapefruit or grapefruit drink within 7 days before intake of Investigational Medicinal Product (IMP) Subject has a clinically significant abnormality in the 12-lead Electrocardiogram (ECG) Subject is having clinically relevant drug hypersensitivity to any components of the investigational medicinal product

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lacosamide 30-minute iv<br>A 30-minute intravenous constant infusion of Lacosamide (LCM) 200 mg (200 mg/20 mL single-use vial). | Drug: Lacosamide infusion<br>* Strength: 10 mg/mL for infusion Form: solution for infusion Dosage: 200 mg, single dose Duration: 30-minute infusion or 60-minute infusion<br>* Other names: Vimpat;|
| Experimental: Lacosamide 60-minute iv<br>60-minute intravenous constant infusion of Lacosamide (LCM) 200 mg (200 mg/20 mL single-use vial). | Drug: Lacosamide infusion<br>* Strength: 10 mg/mL for infusion Form: solution for infusion Dosage: 200 mg, single dose Duration: 30-minute infusion or 60-minute infusion<br>* Other names: Vimpat;|
| Experimental: Lacosamide oral tablet<br>Oral administration of Lacosamide (LCM) 200 mg (2 x 100 mg film-coated tablet) with 200 mL of water. | Drug: Lacosamide oral<br>* Strength: 200 mg Form: film-coated tablet Dosage: 200 mg, single dose Duration: single oral intake<br>* Other names: Vimpat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration of Lacosamide (Cmax) after oral and intravenous administration of Lacosamide |  | Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion) | 
| Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration of Lacosamide (AUC 0-t) after oral and intravenous administration of Lacosamide |  | Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration-time curve from zero up to infinity (AUC) after oral and intravenous administration of Lacosamide |  | Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion) | 
| Time to reach a maximum plasma concentration (tmax) after oral and intravenous administration of Lacosamide |  | Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion) | 
| Mean residence time (MRT) after oral and intravenous administration of Lacosamide |  | Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion) | 
| Rate constant of elimination (λz) after oral and intravenous administration of Lacosamide |  | Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion) | 
| Terminal half-life (t1/2) after oral and intravenous administration of Lacosamide |  | Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion) | 
| Apparent total body clearance (CL/F) after oral administration of Lacosamide |  | Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion) | 
| Total body clearance (CL) after intravenous administration of Lacosamide |  | Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion) | 
| Apparent volume of distribution (Vz/F) after oral administration of Lacosamide |  | Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion) | 
| Volume of distribution (Vz) after intravenous administration of Lacosamide |  | Pharmacokinetic samples will be taken at predose/preinfusion, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose (start of infusion) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lacosamide, Vimpat, Bioequivalence, Bioavailability, Japanese