A Multicenter, Open-label Study to Determine the Effects of Lacosamide on Sleep in Healthy Subjects

Exclusion Criteria

• •Subjects who have participated in previous Lacosamide studies or received Lacosamide
• •Subjects who have received another investigational medication within 30 days or currently participating in an investigational study
• •Subject has a history of or screening polysomnography that reveals sleep disorders (i.e. sleep apnea or narcolepsy)
• •Subject consumes more than 400 mg of caffeine per day
• •Subject has known hypersensitivity to Lacosamide
• •Subject has alcohol or drug abuse within last 2 years
• •Subject who consumes more than 40 g of alcohol per day
• •Subject has a positive alcohol breath test or urine drug screen
• •Subject smokes more than half a pack of cigarettes per day or consumes nicotine products
• •Subject is pregnant / nursing or child-bearing potential female not sterile or using contraception methods
• •Subject is male who does not agree to use contraception
• •Subjects taking any medications currently or within 2 weeks prior to first dose except non-steroidal anti-inflammatory drugs, oral contraceptives, and non-psychoactive supplements
• •Subject has elevated live enzymes greater than 2 times the upper limit of normal
• •Subject has donated blood or had blood loss greater than 400 mL within 3 months prior to first dose
• •Subject has out of range hematology or chemistry parameters
• •Subject has clinically relevant abnormality in physical examination or vital signs
• •Subject has sick sinus syndrome without a pace maker or second or third degree atrioventricular block or clinically significant electrocardiogram finding
• •Subject has sodium channelopathy
• •Subject has experienced a myocardial infarction in last 3 months
• •Subject has New York Heart Association Class III or IV heart failure
• •Subject has a lifetime history of suicide attempts
• •Subject has any medical or psychiatric condition
• •Subject has a known history or severe anaphylactic reaction or serious blood dyscrasias