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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Insomnia

Treatments: Drug: Suvorexant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01059851

2010_505 (Other Identifier)

4305-023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 6 patient groups

Participants with Severe Renal Impairment (Part I)

Experimental group

Description:

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

Treatment:

Drug: Suvorexant

Healthy Participants (Severe Impairment Controls) (Part I)

Experimental group

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.

Treatment:

Drug: Suvorexant

Participants with Moderate Renal Impairment (Part II)

Experimental group

Description:

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

Treatment:

Drug: Suvorexant

Healthy Participants (Moderate Impairment Controls) (Part II)

Experimental group

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.

Treatment:

Drug: Suvorexant

Participants with Mild Renal Impairment (Part II)

Experimental group

Description:

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

Treatment:

Drug: Suvorexant

Healthy Participants (Mild Impairment Controls) (Part II)

Experimental group

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.

Treatment:

Drug: Suvorexant