Pharmacokinetics of Suvorexant in Participants With Hepatic Insufficiency (MK-4305-017)

• Status: Completed
• Trial end date: 2010-04-14
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

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