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

Primary Purpose

Insomnia

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Suvorexant
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Participants with Severe Renal Impairment (Part I)

    Healthy Participants (Severe Impairment Controls) (Part I)

    Participants with Moderate Renal Impairment (Part II)

    Healthy Participants (Moderate Impairment Controls) (Part II)

    Participants with Mild Renal Impairment (Part II)

    Healthy Participants (Mild Impairment Controls) (Part II)

    Arm Description

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

    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.

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

    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.

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

    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.

    Outcomes

    Primary Outcome Measures

    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).
    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).
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 28, 2010
    Last Updated
    October 8, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01059851
    Brief Title
    Pharmacokinetics of Suvorexant in Participants With Impaired Renal Function (MK-4305-023)(COMPLETED)
    Official Title
    An Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of MK-4305 in Patients With Impaired Renal Function
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 24, 2010 (Actual)
    Primary Completion Date
    July 15, 2010 (Actual)
    Study Completion Date
    July 15, 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Study Design: This study plans to enroll 16 participants in Part I (8 participants with severe renal impairment and a control group of 8 healthy participants) and 32 participants in Part II (8 participants with moderate renal impairment and a control group of 8 healthy participants; and 8 participants with mild renal impairment and a control group of 8 healthy participants). Part II will be conducted only if the primary hypothesis is not met in Part I and there is a significant difference in the PK of suvorexant between healthy participants and severe renal impairment participants.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insomnia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Participants with Severe Renal Impairment (Part I)
    Arm Type
    Experimental
    Arm Description
    Participants with severe renal impairment will receive a single dose of 20 mg open-label suvorexant during Part I of the study.
    Arm Title
    Healthy Participants (Severe Impairment Controls) (Part I)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Participants with Moderate Renal Impairment (Part II)
    Arm Type
    Experimental
    Arm Description
    Participants with moderate renal impairment will receive a single dose of 20 mg open-label suvorexant during Part II of the study.
    Arm Title
    Healthy Participants (Moderate Impairment Controls) (Part II)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Participants with Mild Renal Impairment (Part II)
    Arm Type
    Experimental
    Arm Description
    Participants with mild renal impairment will receive a single dose of 20 mg open-label suvorexant during Part II of the study.
    Arm Title
    Healthy Participants (Mild Impairment Controls) (Part II)
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Suvorexant
    Other Intervention Name(s)
    MK-4305
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    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)
    Description
    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).
    Time Frame
    Predose and 0.5, 1, 2, 4, 6, 9, 12, 16, 24, 48, 72, 96, and 120 hours post-dose
    Title
    AUC(0-∞) After Single Dose Suvorexant: Moderate and Mild Renal Impairment Participants Versus Healthy Participants (Part II)
    Description
    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).
    Time Frame
    Predose and 0.5, 1, 2, 4, 6, 9, 12, 16, 24, 48, 72, 96, and 120 hours post-dose
    Title
    Number of Participants With an Adverse Event (AE)
    Description
    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.
    Time Frame
    From administration of study drug through 14 days after administration of study drug
    Title
    Number of Participants Who Discontinued Study Due to an AE
    Description
    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.
    Time Frame
    From administration of study drug through 14 days after administration of study drug

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/study.html?id=4305-023&kw=4305-023&tab=access

    Learn more about this trial

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

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