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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Single Dose Study to Investigate the Pharmacokinetics of MK-4305 in Patients With Hepatic Insufficiency

Brief 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.

Detailed Summary:

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.


Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome:

  • 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) [ Time Frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose ]
    Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC[0-last]) and Ct/λ, where Ct was the last measurable concentration and λ was the apparent terminal rate constant.
  • AUC(0-∞) After Single Dose Suvorexant: Mild Hepatic Insufficiency Participants Versus Healthy Participants (Part II) [ Time Frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose ]
    Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC[0-last]) and Ct/λ, where Ct was the last measurable concentration and λ was the apparent terminal rate constant.


Original Primary Outcome:

  • Area under the plasma concentration versus time curve (AUC) in patients with moderate hepatic insufficiency compared to that in healthy subjects [ Time Frame: Up to 144 hours post dose ]
  • Area under the plasma concentration versus time curve (AUC) in patients with mild hepatic insufficiency compared to that in healthy subjects [ Time Frame: Up to 144 hours post dose ]


Current Secondary Outcome:

  • Maximum Plasma Concentration (Cmax) of Suvorexant After Single Dose: Moderate Hepatic Insufficiency Participants Versus Healthy Participants [ Time Frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose ]
    Cmax was defined as the maximum observed concentration of a drug after administration.
  • Number of Participants With an Adverse Event (AE) [ Time Frame: From administration of study drug through 14 days after administration of study drug ]
    An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.
  • Number of Participants Who Discontinued Study Due to an AE [ Time Frame: From administration of study drug through 14 days after administration of study drug ]
    An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.


Original Secondary Outcome: Safety and tolerability of MK4305 measured by the number of clinical and laboratory adverse events [ Time Frame: Through 14 days after administration of study drug ]

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: January 5, 2010
Date Started: February 2010
Date Completion:
Last Updated: April 7, 2015
Last Verified: April 2015