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

• Status: Completed
• Trial end date: 2010-07-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Suvorexant

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