pharmacokinetics of suvorexant in participants with hepatic insufficiency (mk-4305-017)

Conditions: Insomnia; Hepatic Insufficiency

Summary: this study will determine whether the plasma concentration-time profile and pharmacokinetics (pk) of suvorexant (mk-4305) in participants with moderate and mild hepatic insufficiency are similar to those observed in healthy participants.

study design: this study plans to enroll 16 participants in part i (8 participants with moderate hepatic insufficiency and 8 healthy participants) and 16 participants in part ii (8 participants with mild hepatic insufficiency and 8 healthy participants). part ii will be conducted only if the primary hypothesis is not met and there is a significant difference in the pk of suvorexant between healthy participants and moderate hepatic insufficiency participants in part i.

Eligibility criteria:
inclusion criteria for hepatic insufficiency participants: * females of reproductive potential must have a negative pregnancy test and agree to use (and/or have their partner use) two acceptable methods of birth control * body mass index (bmi) ≤35 kg/m\^2 prior to start of study * diagnosis of stable hepatic insufficiency * smoking is restricted to ≤10 cigarettes per day inclusion criteria for healthy matched participants: * females of reproductive potential must have a negative pregnancy test and agree to use (and/or have their partner use) two acceptable methods of birth control * bmi within approximately 20% of that of his/her hepatic participant * participant is healthy * participant is matched by race, gender, age (+/- 5 yrs) to his/her hepatic participant enrolled in the study * smoking is restricted to ≤10 cigarettes per day exclusion criteria for hepatic insufficiency participants: * participant is mentally or legally incapacitated * history of a clinically significant psychiatric disorder over the last 5 to 10 years * participant has a history of any illness not related to his/her hepatic insufficiency * history of a persistent sleep abnormality occurring for at least three (3) months * participant 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 * participant is a nursing mother * participant consumes \>3 servings of alcohol a day * participant consumes \>6 caffeine servings a day * history of multiple and/or severe allergies * participant is currently using or has history of illegal drug use * participant has traveled across 3 or more time zones within 2 weeks of study participation * participant 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 participants: * participant is mentally or legally incapacitated. history of a clinically significant psychiatric disorder over the last 5 to 10 years. * participant has a history of any illness * history of a persistent sleep abnormality occurring for at least three (3) months * participant has a history of stroke, chronic seizures, or major neurological disorder * history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities, uncomplicated kidney stones or childhood asthma * history of cancer * history of cataplexy * participant is a nursing mother * participant consumes \>3 servings of alcohol a day * participant consumes \>6 caffeine servings a day * history of multiple and/or severe allergies * participant is currently using or has history of illegal drug use * participant has a history of any chronic and/or active hepatic disease * participant has traveled across 3 or more time zones within 2 weeks of study participation * participant works a night shift and is not able to avoid night shift work within 1 week before each treatment visit

Keywords: hepatic insufficiency