Pharmacokinetics of Suvorexant in Participants With Impaired Renal Function (MK-4305-023)(COMPLETED)
Condition: Insomnia
MeSH terms: Renal Insufficiency
Intervention: Suvorexant
Intervention description: single oral dose of 20 mg (administered as 2 x 10 mg tablets) of suvorexant administered with ~240 mL of water after an 8 hour fast
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: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will investigate whether the plasma concentration-time profile and
      pharmacokinetics (PK) of suvorexant (MK-4305) in participants with impaired renal function
      are similar to those observed in healthy participants; and will evaluate the safety and
      tolerability of suvorexant both in participants with impaired renal function and in healthy
      participants.
    

Eligibility criteria:

        Inclusion Criteria:

        Impaired Renal Function 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) ≤40 kg/m^2

          -  Diagnosis of renal insufficiency

        Healthy 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) ≤40 kg/m^2 and is matched for BMI ± 5 units to his/her
             corresponding renal participant

          -  In general good health

          -  Matched for age ± 10 years to his/her corresponding renal participant

        Exclusion Criteria:

        Impaired Renal Function Participants:

          -  Is mentally or legally incapacitated

          -  History of a clinically significant psychiatric disorder over the last year

          -  Has rapidly fluctuating renal function or has demonstrated or suspected renal artery
             stenosis

          -  Has had a kidney transplant

          -  Unstable endocrine, gastrointestinal, cardiovascular, hematological, immunological,
             respiratory, or genitourinary diseases

          -  History of cancer (Some exceptions apply)

          -  Regular user of barbiturates or sleep aides

          -  Consumes excessive amounts of alcohol (>2 drinks/day)

          -  Consumes excessive amounts of caffeinated beverages (>6/day)

          -  Has had major surgery within 4 weeks

          -  Has a history of significant multiple and/or severe allergies

          -  Has a history of cataplexy

          -  Participant works a night shift and is not able to avoid night shift work during the
             study

          -  Current or history of illicit drug abuse

          -  Nursing mothers

        Healthy Participants:

          -  Is mentally or legally incapacitated;

          -  Has a history of stroke, chronic seizures, or major neurological disorder

          -  Unstable endocrine, gastrointestinal, cardiovascular, hematological, immunological,
             respiratory, or genitourinary diseases

          -  History of cancer (Some exceptions apply)

          -  Regular user of barbiturates or sleep aides

          -  Consumes excessive amounts of alcohol (>2 drinks/day)

          -  Consumes excessive amounts of caffeinated beverages (>6/day)

          -  Has had major surgery within 4 weeks

          -  Has a history of significant multiple and/or severe allergies

          -  Has a history of cataplexy

          -  Participant works a night shift and is not able to avoid night shift work during the
             study

          -  Current or history of illicit drug abuse

          -  Nursing mothers