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

• Maximum drug concentration (Cmax) of lacosamide in plasma. [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
• Area under the curve from 0 to the time of the last quantifiable concentration (AUC(0-t)) of lacosamide in plasma [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
• Area under the curve from 0 to infinity (AUC) of lacosamide in plasma [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]

• Time to reach maximum plasma concentration (tmax) of lacosamide in plasma [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
• Terminal half-life (t½) of lacosamide in plasma [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
• Apparent total body clearance (CL/F) of lacosamide in plasma [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
• Apparent volume of distribution (Vz/F) of lacosamide in plasma [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
• Mean resident time (MRT) of lacosamide in plasma. [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
• First order terminal elimination rate constant (λZ ) of lacosamide in plasma [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
• Maximum drug concentration (Cmax) of SPM12809 in plasma. [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
• Area under the curve from 0 to the time of the last quantifiable concentration (AUC(0-t)) of SPM12809 in plasma [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
• Area under the curve from 0 to infinity (AUC) of SPM12809 in plasma [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
• Time to reach maximum plasma concentration (tmax) of SPM12809 in plasma [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
• Terminal half-life (t½) of SPM12809 in plasma [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
• First order terminal elimination rate constant (λZ ) of SPM12809 in plasma [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
• Total amount of drug excreted in urine (Ae) of lacosamide and SPM12809 [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
• Fraction of dose excreted in urine (fe) of lacosamide and SPM12809 [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
• Renal clearance (CLR) of lacosamide and SPM12809 [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
• Apparent formation clearance of metabolites (CLfm/F) [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
• AUC Ratio [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]

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.

• Drug: Lacosamide
  100 mg oral tablet, single dose
  Other Name: Vimpat®
• Drug: Lacosamide
  Lacosamide 2 X 100 mg tablet
  Other Name: Vimpat®
• Drug: Lacosamide
  Lacosamide 4 X 100mg tablet
  Other Name: Vimpat®
• Other: Placebo 3
  Placebo - 3 tablets
• Other: Placebo 4
  Placebo - 4 tablets
• Other: Placebo 2
  Placebo - 2 tablets

• Experimental: Lacosamide 100 mg, Japanese
  1 Lacosamide 100 mg tablet plus 3 placebo tablets
  Interventions:

  • Drug: Lacosamide
  • Other: Placebo 3
• Experimental: Lacosamide 100 mg, Chinese
  1 Lacosamide 100 mg tablet plus 3 placebo tablets
  Interventions:

  • Drug: Lacosamide
  • Other: Placebo 3
• Experimental: Lacosamide 200 mg, Japanese
  2 Lacosamide 100 mg tablets plus 2 placebo tablets
  Interventions:

  • Drug: Lacosamide
  • Other: Placebo 2
• Experimental: Lacosamide 200 mg, Chinese
  2 Lacosamide 100 mg tablets plus 2 placebo tablets
  Interventions:

  • Drug: Lacosamide
  • Other: Placebo 2
• Experimental: Lacosamide 400 mg, Japanese
  4 Lacosamide 100 mg tablets
  Intervention: Drug: Lacosamide
• Experimental: Lacosamide 400 mg, Chinese
  4 Lacosamide 100 mg tablets
  Intervention: Drug: Lacosamide
• Placebo Comparator: Placebo Comparator, Japanese
  4 placebo tablets
  Intervention: Other: Placebo 4
• Placebo Comparator: Placebo Comparator, Chinese
  4 placebo tablets
  Intervention: Other: Placebo 4

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)