pharmacokinetics of suvorexant in participants with impaired renal function (mk-4305-023)(completed)

Conditions: Insomnia

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.

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.

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