Intervention: Suvorexant
Trial phase: Phase 1
ATC code: N05CJ01 | N05CM19
SMILES: [H][C@@]1(C)CCN(c2nc3cc(Cl)ccc3o2)CCN1C(=O)c1cc(C)ccc1-n1nccn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
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