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Pharmacokinetics of Suvorexant in Participants With Hepatic Insufficiency (MK-4305-017)

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 1

Conditions

Hepatic Insufficiency
Insomnia

Treatments

Drug: Suvorexant

Study type

Interventional

Funder types

Industry

Identifiers

NCT01043926
4305-017
2010_500 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Study Design:

This study plans to enroll 16 participants in Part I (8 participants with moderate hepatic insufficiency and 8 healthy participants) and 16 participants in Part II (8 participants with mild hepatic insufficiency and 8 healthy participants).

Part II will be conducted only if the primary hypothesis is not met and there is a significant difference in the PK of suvorexant between healthy participants and moderate hepatic insufficiency participants in Part I.

Enrollment

16 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

16 participants in 4 patient groups

Participants with Moderate Hepatic Insufficiency (Part I)
Experimental group
Description:
Participants with moderate hepatic insufficiency will receive a single dose of 20 mg open-label suvorexant during Part I of the study.
Treatment:
Drug: Suvorexant
Healthy Participants (Part I)
Experimental group
Description:
Healthy participants matched to participants with moderate hepatic insufficiency will receive a single dose of 20 mg open-label suvorexant during Part I of the study.
Treatment:
Drug: Suvorexant
Participants with Mild Hepatic Insufficiency (Part II)
Experimental group
Description:
Participants with mild hepatic insufficiency will receive a single dose of 20 mg open-label suvorexant during Part II of the study (if conducted).
Treatment:
Drug: Suvorexant
Healthy Participants (Part II)
Experimental group
Description:
Healthy participants matched to participants with mild hepatic insufficiency will receive a single dose of 20 mg open-label suvorexant during Part II of the study (if conducted).
Treatment:
Drug: Suvorexant

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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