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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01059851
First received: January 28, 2010
Last updated: August 19, 2014
Last verified: August 2014

January 28, 2010
August 19, 2014
May 2010
July 2010   (final data collection date for primary outcome measure)
  • 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) [ Time Frame: Predose and 0.5, 1, 2, 4, 6, 9, 12, 16, 24, 48, 72, 96, and 120 hours post-dose ] [ Designated as safety issue: No ]
    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) [ Time Frame: Predose and 0.5, 1, 2, 4, 6, 9, 12, 16, 24, 48, 72, 96, and 120 hours post-dose ] [ Designated as safety issue: No ]
    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) [ Time Frame: From administration of study drug through 14 days after administration of study drug ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: From administration of study drug through 14 days after administration of study drug ] [ Designated as safety issue: Yes ]
    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.
Area under the plasma concentration versus time curve (AUC) [ Time Frame: Up to 120 hours postdose ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01059851 on ClinicalTrials.gov Archive Site
Not Provided
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Pharmacokinetics of Suvorexant in Participants With Impaired Renal Function (MK-4305-023)(COMPLETED)
An Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of MK-4305 in Patients With Impaired Renal Function

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Insomnia
Drug: Suvorexant
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
Other Name: MK-4305
  • Experimental: Participants with Severe Renal Impairment (Part I)

    Participants with severe renal impairment will receive a

    single dose of 20 mg open-label suvorexant during Part I of the

    study.

    Intervention: Drug: Suvorexant
  • Experimental: Healthy Participants (Severe Impairment Controls) (Part I)
    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.
    Intervention: Drug: Suvorexant
  • Experimental: Participants with Moderate Renal Impairment (Part II)
    Participants with moderate renal impairment will receive a single dose of 20 mg open-label suvorexant during Part II of the study.
    Intervention: Drug: Suvorexant
  • Experimental: Healthy Participants (Moderate Impairment Controls) (Part II)
    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.
    Intervention: Drug: Suvorexant
  • Experimental: Participants with Mild Renal Impairment (Part II)
    Participants with mild renal impairment will receive a single dose of 20 mg open-label suvorexant during Part II of the study.
    Intervention: Drug: Suvorexant
  • Experimental: Healthy Participants (Mild Impairment Controls) (Part II)
    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: Drug: Suvorexant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01059851
4305-023, 2010_505
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP