Phase 1
N=16
Pharmacokinetics of Suvorexant in Participants With Hepatic Insufficiency (MK-4305-017)
Insomnia · Hepatic Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT01043926 ↗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: Moderate Hepatic Insufficiency Participants Versus Healthy Participants (Part I) — 14.09; 13.73 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
- Apr 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: Moderate Hepatic Insufficiency Participants Versus Healthy Participants (Part I) |
14.09; 13.73 | — |
| PRIMARY AUC(0-∞) After Single Dose Suvorexant: Mild Hepatic Insufficiency Participants Versus Healthy Participants (Part II) |
— | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Suvorexant After Single Dose: Moderate Hepatic Insufficiency Participants Versus Healthy Participants |
0.800; 0.854 | — |
| SECONDARY Number of Participants With an Adverse Event (AE) |
7; 5 | — |
| SECONDARY Number of Participants Who Discontinued Study Due to an AE |
0; 0 | — |
Summary
This study will determine whether the plasma concentration-time profile and pharmacokinetics (PK) of suvorexant (MK-4305) in participants with moderate and mild hepatic insufficiency are similar to those observed in healthy participants.
Eligibility Criteria
Inclusion Criteria for Hepatic Insufficiency 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) ≤35 kg/m^2 prior to start of study
- Diagnosis of stable hepatic insufficiency
- Smoking is restricted to ≤10 cigarettes per day
Inclusion Criteria for Healthy Matched 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
- BMI within approximately 20% of that of his/her hepatic participant
- Participant is healthy
- Participant is matched by race, gender, age (+/- 5 yrs) to his/her hepatic participant enrolled in the study
- Smoking is restricted to ≤10 cigarettes per day
Exclusion Criteria for Hepatic Insufficiency Participants:
- Participant is mentally or legally incapacitated
- History of a clinically significant psychiatric disorder over the last 5 to 10 years
- Participant has a history of any illness not related to his/her hepatic insufficiency
- History of a persistent sleep abnormality occurring for at least three (3)
months
- Participant has a history of stroke, chronic seizures, or major neurological disorder
- History of clinically significant hematological, immunological, renal,
respiratory, or genitourinary abnormalities, uncomplicated kidney stones or childhood asthma
- History of cancer
- History of cataplexy
- Participant is a nursing mother
- Participant consumes >3 servings of alcohol a day
- Participant consumes >6 caffeine servings a day
- History of multiple and/or severe allergies
- Participant is currently using or has history of illegal drug use
- Participant has traveled across 3 or more time zones within 2 weeks of study participation
- Participant works a night shift and is not able to avoid night shift work within 1 week before each treatment visit
Exclusion Criteria for Healthy Matched Participants:
- Participant is mentally or legally incapacitated. History of a clinically significant psychiatric disorder over the last 5 to 10 years.
- Participant has a history of any illness
- History of a persistent sleep abnormality occurring for at least three (3) months
- Participant has a history of stroke, chronic seizures, or major neurological disorder
- History of clinically significant endocrine, gastrointestinal,
cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities, uncomplicated kidney stones or childhood asthma
- History of cancer
- History of cataplexy
- Participant is a nursing mother
- Participant consumes >3 servings of alcohol a day
- Participant consumes >6 caffeine servings a day
- History of multiple and/or severe allergies
- Participant is currently using or has history of illegal drug use
- Participant has a history of any chronic and/or active hepatic disease
- Participant has traveled across 3 or more time zones within 2 weeks of study participation
- Participant works a night shift and is not able to avoid night shift work within 1 week before each treatment visit
Data sourced from ClinicalTrials.gov (NCT01043926). 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.