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
  Purpose

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.


Condition Intervention Phase
Insomnia
Drug: Suvorexant
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of MK-4305 in Patients With Impaired Renal Function

Further study details as provided by Merck Sharp & Dohme Corp.:

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) [ 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.


Enrollment: 16
Study Start Date: May 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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: 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.
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 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.
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: 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.
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 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.
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: 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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059851

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01059851     History of Changes
Other Study ID Numbers: 4305-023, 2010_505
Study First Received: January 28, 2010
Results First Received: August 19, 2014
Last Updated: August 19, 2014
Health Authority: Russia: Pharmacological Committee, Ministry of Health

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 22, 2014