Pharmacokinetics of Suvorexant in Participants With Impaired Renal Function (MK-4305-023)(COMPLETED)

An Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of MK-4305 in Patients With Impaired Renal Function

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.

Study Design:

This study plans to enroll 16 participants in Part I (8 participants with severe renal impairment and a control group of 8 healthy participants) and 32 participants in Part II (8 participants with moderate renal impairment and a control group of 8 healthy participants; and 8 participants with mild renal impairment and a control group of 8 healthy participants).

Part II will be conducted only if the primary hypothesis is not met in Part I and there is a significant difference in the PK of suvorexant between healthy participants and severe renal impairment participants.

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