Phase 1
N=16
Pharmacokinetics of Suvorexant in Participants With Impaired Renal Function (MK-4305-023)(COMPLETED)
Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT01059851 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: 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) — 11.98; 9.81 μM•hr
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Suvorexant (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
11.98; 9.81 | — |
| PRIMARY AUC(0-∞) After Single Dose Suvorexant: Moderate and Mild Renal Impairment Participants Versus Healthy Participants (Part II) |
— | — |
| PRIMARY Number of Participants With an Adverse Event (AE) |
2; 4 | — |
| PRIMARY Number of Participants Who Discontinued Study Due to an AE |
0; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01059851). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.