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

NCT01043926 | Completed Phase 1 Results

• 2 other identifiers: 4305-0172010_500
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Insomnia; Hepatic Insufficiency

Keywords

Hepatic Insufficiency

Outcome Measures

Primary Outcomes (2)

• Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-∞) After Single Dose Suvorexant: Moderate Hepatic Insufficiency Participants Versus Healthy Participants (Part I)

  Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC\[0-∞\]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC\[0-last\]) and Ct/λ, where Ct was the last measurable concentration and λ was the apparent terminal rate constant.

  Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose

• AUC(0-∞) After Single Dose Suvorexant: Mild Hepatic Insufficiency Participants Versus Healthy Participants (Part II)

  Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC\[0-∞\]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC\[0-last\]) and Ct/λ, where Ct was the last measurable concentration and λ was the apparent terminal rate constant.

  Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose

Secondary Outcomes (3)

• Maximum Plasma Concentration (Cmax) of Suvorexant After Single Dose: Moderate Hepatic Insufficiency Participants Versus Healthy Participants

  Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose

• Number of Participants With an Adverse Event (AE)

  From administration of study drug through 14 days after administration of study drug

• Number of Participants Who Discontinued Study Due to an AE

  From administration of study drug through 14 days after administration of study drug

Study Arms (4)

Participants with Moderate Hepatic Insufficiency (Part I)

EXPERIMENTAL

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

Drug: Suvorexant

Healthy Participants (Part I)

EXPERIMENTAL

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.

Drug: Suvorexant

Participants with Mild Hepatic Insufficiency (Part II)

EXPERIMENTAL

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

Drug: Suvorexant

Healthy Participants (Part II)

EXPERIMENTAL

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).

Drug: Suvorexant

Interventions

Suvorexant 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.

Also known as: MK-4305

Healthy Participants (Part I); Healthy Participants (Part II); Participants with Mild Hepatic Insufficiency (Part II); Participants with Moderate Hepatic Insufficiency (Part I)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Hepatic Insufficiency

Interventions

suvorexant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2010
• First Posted: January 7, 2010
• Study Start: February 22, 2010
• Primary Completion: April 14, 2010
• Study Completion: April 14, 2010
• Last Updated: September 21, 2018
• Results First Posted: August 29, 2014

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share