Pharmacokinetics of MK4305 in Patients With Hepatic Insufficiency

Inclusion Criteria for Hepatic Insufficiency Patients:

• Females of reproductive potential must have a negative pregnancy test and agree to use two methods of birth control
• Body Mass Index (BMI) <=35 kg/m prior to start of study
• Diagnosis of stable hepatic insufficiency
• Smoking is restricted to <= 10 cigarettes per day

Inclusion Criteria for Healthy Matched Subjects:

• Females of reproductive potential must have a negative pregnancy test and agree to use two methods of birth control
• BMI within approximately 20% of that of his/her hepatic subject
• Healthy subject
• Subject is matched by race, gender, age (+/- 5 yrs) to his/her hepatic subject enrolled in the study

Exclusion Criteria for Hepatic Insufficiency Patients:

• Patient is mentally or legally incapacitated
• History of a clinically significant psychiatric disorder over the last 5 to 10 years
• Patient has a history of any illness not related to his/her hepatic insufficiency
• History of a persistent sleep abnormality occurring for three (3) months
• Patient has a history of stroke, chronic seizures, or major neurological disorder
• History of clinically significant hematological, immunological, renal, respiratory, or genitourinary abnormalities, uncomplicated kidney stones or childhood asthma
• History of cancer
• History of cataplexy
• Patient is a nursing mother
• Patient consumes more than 3 servings of alcohol a day
• Caffeine consumption should be limited to <= then 6 servings a day
• History of multiple and/or severe allergies
• Patient is currently using or has history of illegal drug use
• Patient has a history of any chronic and/or active hepatic disease
• Patient has traveled across 3 or more time zones
• Patient works a night shift and is not able to avoid night shift work within 1 week before each treatment visit

Exclusion Criteria for Healthy Matched Subjects:

• Subject is mentally or legally incapacitated. History of a clinically significant psychiatric disorder over the last 5 to 10 years.
• Subject has a history of any illness
• History of a persistent sleep abnormality occurring for three (3) months
• Subject has a history of stroke, chronic seizures, or major neurological disorder
• History of clinically significant hematological, immunological, renal, respiratory, or genitourinary abnormalities, uncomplicated kidney stones or childhood asthma
• History of cancer
• History of cataplexy
• Subject is a nursing mother
• Subject consumes more than 3 servings of alcohol a day
• Caffeine consumption should be limited to <= then 6 servings a day
• History of multiple and/or severe allergies
• Subject is currently using or has history of illegal drug use
• Subject has a history of any chronic and/or active hepatic disease
• Subject has traveled across 3 or more time zones
• Subject works a night shift and is not able to avoid night shift work within 1 week before each treatment visit