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

NCT01059851 | Completed Phase 1 Results

• 2 other identifiers: 4305-0232010_505
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (4)

• Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-∞) After Single Dose Suvorexant: Severe Renal Impairment 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 the extrapolated area given by the quotient of the last detectable concentration and the apparent terminal rate constant (λ).

  Predose and 0.5, 1, 2, 4, 6, 9, 12, 16, 24, 48, 72, 96, and 120 hours post-dose

• AUC(0-∞) After Single Dose Suvorexant: Moderate and Mild Renal Impairment 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 the extrapolated area given by the quotient of the last detectable concentration and the apparent terminal rate constant (λ).

  Predose and 0.5, 1, 2, 4, 6, 9, 12, 16, 24, 48, 72, 96, and 120 hours post-dose

• Number of Participants With an Adverse Event (AE)

  An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.

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

• Number of Participants Who Discontinued Study Due to an AE

  An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.

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

Study Arms (6)

Participants with Severe Renal Impairment (Part I)

EXPERIMENTAL

Participants with severe renal impairment will receive a single dose of 20 mg open-label suvorexant during Part I of the study.

Drug: Suvorexant

Healthy Participants (Severe Impairment Controls) (Part I)

EXPERIMENTAL

Healthy participants matched to participants with severe renal impairment will receive a single dose of 20 mg open-label suvorexant during Part I of the study.

Drug: Suvorexant

Participants with Moderate Renal Impairment (Part II)

EXPERIMENTAL

Participants with moderate renal impairment will receive a single dose of 20 mg open-label suvorexant during Part II of the study.

Drug: Suvorexant

Healthy Participants (Moderate Impairment Controls) (Part II)

EXPERIMENTAL

Healthy participants matched to participants with moderate renal impairment will receive a single dose of 20 mg open-label suvorexant during Part II of the study.

Drug: Suvorexant

Participants with Mild Renal Impairment (Part II)

EXPERIMENTAL

Participants with mild renal impairment will receive a single dose of 20 mg open-label suvorexant during Part II of the study.

Drug: Suvorexant

Healthy Participants (Mild Impairment Controls) (Part II)

EXPERIMENTAL

Healthy participants matched to participants with mild renal impairment will receive a single dose of 20 mg open-label suvorexant during Part II of the study.

Drug: Suvorexant

Interventions

Suvorexant DRUG

single oral dose of 20 mg (administered as 2 x 10 mg tablets) of suvorexant administered with \~240 mL of water after an 8 hour fast

Also known as: MK-4305

Healthy Participants (Mild Impairment Controls) (Part II); Healthy Participants (Moderate Impairment Controls) (Part II); Healthy Participants (Severe Impairment Controls) (Part I); Participants with Mild Renal Impairment (Part II); Participants with Moderate Renal Impairment (Part II); Participants with Severe Renal Impairment (Part I)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

suvorexant

Condition Hierarchy (Ancestors)

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

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 28, 2010
• First Posted: February 1, 2010
• Study Start: May 24, 2010
• Primary Completion: July 15, 2010
• Study Completion: July 15, 2010
• Last Updated: November 6, 2018
• Results First Posted: August 29, 2014

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share