Clinical trial NCT01059851: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Insomnia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-02-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
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)
timeFrame: Predose and 0.5, 1, 2, 4, 6, 9, 12, 16, 24, 48, 72, 96, and 120 hours post-dose
measure: AUC(0-∞) After Single Dose Suvorexant: Moderate and Mild Renal Impairment Participants Versus Healthy Participants (Part II)
timeFrame: Predose and 0.5, 1, 2, 4, 6, 9, 12, 16, 24, 48, 72, 96, and 120 hours post-dose
measure: Number of Participants With an Adverse Event (AE)
timeFrame: From administration of study drug through 14 days after administration of study drug
measure: Number of Participants Who Discontinued Study Due to an AE
timeFrame: From administration of study drug through 14 days after administration of study drug
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: