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

Insomnia Clinical Trial

Official title:

An Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of MK-4305 in Patients With Impaired Renal Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01059851
• Other study ID #: 4305-023
• Secondary ID: 2010_505
• Status: Completed
• Phase: Phase 1
• Start date: May 24, 2010
• Est. completion date: July 15, 2010

Study information

• Verified date: October 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 15, 2010
• Est. primary completion date: July 15, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-8) 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[0-8]). AUC(0-8) 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 (?).	Predose and 0.5, 1, 2, 4, 6, 9, 12, 16, 24, 48, 72, 96, and 120 hours post-dose
Primary	AUC(0-8) 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[0-8]). AUC(0-8) 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 (?).	Predose and 0.5, 1, 2, 4, 6, 9, 12, 16, 24, 48, 72, 96, and 120 hours post-dose
Primary	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
Primary	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