Pharmacokinetics of Suvorexant in Participants With Hepatic Insufficiency (MK-4305-017)
Condition: Insomnia; Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Intervention: Suvorexant
Intervention description: single 20 mg dose of suvorexant will be administered as 2 x 10 mg film coated tablets on Day 1 after an overnight fast with water.
Intervention MeSH terms: Suvorexant
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: 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.
    

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