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

NCT ID: NCT01043926

Last Updated: 2018-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-22
• Study Completion Date: 2010-04-14

Brief 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.

Detailed Description

Study Design:

This study plans to enroll 16 participants in Part I (8 participants with moderate hepatic insufficiency and 8 healthy participants) and 16 participants in Part II (8 participants with mild hepatic insufficiency and 8 healthy participants).

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

Conditions

Insomnia; Hepatic Insufficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participants with Moderate Hepatic Insufficiency (Part I)

Participants with moderate hepatic insufficiency will receive a single dose of 20 mg open-label suvorexant during Part I of the study.

Group Type: EXPERIMENTAL

Suvorexant

Intervention Type: DRUG

single 20 mg dose of suvorexant will be administered as 2 x 10 mg film coated tablets on Day 1 after an overnight fast with water.

Healthy Participants (Part I)

Healthy participants matched to participants with moderate hepatic insufficiency will receive a single dose of 20 mg open-label suvorexant during Part I of the study.

Group Type: EXPERIMENTAL

Suvorexant

Intervention Type: DRUG

single 20 mg dose of suvorexant will be administered as 2 x 10 mg film coated tablets on Day 1 after an overnight fast with water.

Participants with Mild Hepatic Insufficiency (Part II)

Participants with mild hepatic insufficiency will receive a single dose of 20 mg open-label suvorexant during Part II of the study (if conducted).

Group Type: EXPERIMENTAL

Suvorexant

Intervention Type: DRUG

single 20 mg dose of suvorexant will be administered as 2 x 10 mg film coated tablets on Day 1 after an overnight fast with water.

Healthy Participants (Part II)

Healthy participants matched to participants with mild hepatic insufficiency will receive a single dose of 20 mg open-label suvorexant during Part II of the study (if conducted).

Group Type: EXPERIMENTAL

Suvorexant

Intervention Type: DRUG

single 20 mg dose of suvorexant will be administered as 2 x 10 mg film coated tablets on Day 1 after an overnight fast with water.

Interventions

Suvorexant

single 20 mg dose of suvorexant will be administered as 2 x 10 mg film coated tablets on Day 1 after an overnight fast with water.

Intervention Type: DRUG

Other Intervention Names

MK-4305

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

2010_500

Identifier Type: OTHER

Identifier Source: secondary_id

4305-017

Identifier Type: -

Identifier Source: org_study_id