Clinical Trial: The Influence of Hepatic Insufficiency on the Pharmacokinetics of Elbasvir (MK-8742) (MK-8742-009)

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

Official Title: A Three-Part, Open-Label, Single-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK-8742

Brief Summary: The purpose of this study is to evaluate the pharmacokinetics (PK) profile of elbasvir (MK-8742) after a single dose to participants with mild, moderate, or severe hepatic insufficiency compared with healthy controls.

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome:

  • Area Under the Curve From 0 to Infinity (AUC0-inf) of Elbasvir [ Time Frame: Predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 ]
    Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the AUC0-inf of elbasvir.
  • Area Under the Curve From 0 to 24 Hours (AUC0-24hr) of Elbasvir [ Time Frame: Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, and 24 ]
    Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 to determine the AUC0-24hr of elbasvir.
  • Maximum Concentration (Cmax) of Elbasvir [ Time Frame: Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, 24, 48, 96, 144, and 168 ]
    Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the Cmax of Elbasvir.
  • Concentration at 24 Hours (C24) After Dosing Elbasvir [ Time Frame: Hour 24 ]
    Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24, to determine the concentration of elbasvir at Hour 24 was determined.
  • Time to Maximum Concentration (Tmax) of Elbasvir [ Time Frame: Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, 24, 48, 96, 144, and 168 ]
    Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the maximum concentration (Cmax) of elbasvir. The time to reach Cmax (Tmax) was determined.

  • Original Primary Outcome:

    • Area Under the Curve from 0 to Infinity (AUC 0-inf) of MK-8742 [ Time Frame: Predose on Day 1 up to Day 8 Postdose ]
    • Area Under the Curve from 0 to 24 Hours (AUC 0-24hr) of MK-8742 [ Time Frame: Up to 24 Hours Postdose ]
    • Maximum Concentration (Cmax) of MK-8742 [ Time Frame: Predose on Day 1 up to Day 8 Postdose ]
    • Concentration at 24 hours (C24) After Dosing MK-8742 [ Time Frame: Up to 24 Hours Postdose ]
    • Time to Maximum Concentration (Tmax) of MK-8742 [ Time Frame: Predose on Day 1 up to Day 8 Postdose ]
    • Apparent Terminal Half-Life (t1/2) of MK-8742 [ Time Frame: Predose on Day 1 up to Day 8 Postdose ]


    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Merck Sharp & Dohme Corp.

    Dates:
    Date Received: February 20, 2013
    Date Started: March 2013
    Date Completion:
    Last Updated: September 28, 2016
    Last Verified: September 2016