Clinical Trial: Assessment of Pharmacokinetics of Single Dose Odanacatib (MK-0822) in Subjects With Moderate Hepatic Insufficiency (MK-0822-070)

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

Official Title: Single Dose Study to Investigate the Pharmacokinetics of Odanacatib (MK-0822) in Subjects With Hepatic Insufficiency

Brief Summary: This open-label, non-randomized study was designed to compare pharmacokinetics of a single 50 milligram (mg) dose of MK-0822 in participants with and without moderate hepatic insufficiency (abnormal liver function) in order to determine to what degree hepatic dysfunction may impact therapeutic blood levels of MK-0822.

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome: Area Under the Curve from Zero (0) Hours to Infinity (AUC (0-∞)) After Single Dose MK-0822 [ Time Frame: From time of administration of MK-0822, defined as 0 hours on Study Day 1, to 336 hours (postdose on Post Study Day 15) (Interim postdose blood draws are scheduled at 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, and 240 hours). ]

AUC (0∞) is defined as: area under the plasma (serum) concentration-time curve from zero to infinity. For this study, pre-determined blood-draw time points will range from 0 hours, at time of administration of MK-0822 on Study Day 1, to 336 hours on Post-Study Day 15.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Maximum Plasma Concentration (C (max)) After Single Dose MK-0822 [ Time Frame: From time of administration of MK-0822, defined as 0 hours on Study Day 1, to 336 hours (postdose on Post Study Day 15) (Interim postdose blood draws are scheduled at 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, and 240 hours). ]
    C (max) is defined as: the peak plasma (serum) concentration of a therapeutic drug. For this study, pre-determined blood-draw time points will range from 0 hours, at time of administration of MK-0822 on Study Day 1, to 336 hours on Post-Study Day 15.
  • Time to Maximum Plasma Concentration (T (max)) After Single Dose MK-0822 [ Time Frame: From time of administration of MK-0822, defined as 0 hours on Study Day 1, to 336 hours (postdose on Post Study Day 15) (Interim postdose blood draws are scheduled at 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, and 240 hours). ]
    T (max) is defined as the time it takes the administered drug to reach maximum (peak) plasma (serum) concentration. For this study, pre-determined blood-draw time points will range from 0 hours, at time of administration of MK-0822 on Study Day 1, to 336 hours on Post-Study Day 15.
  • Apparent Terminal Half-Life (t(½)) After Single Dose MK-0822 [ Time Frame: From time of administration of MK-0822, defined as 0 hours on Study Day 1, to 336 hours (postdose on Post Study Day 15) (Interim postdose blood draws are scheduled at 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, and 240 hours). ]
    Apparent terminal half-life is the time required to divide the plasma (serum) concentration by two after reaching pseudo-equilibrium. (Note: it is not the time required to eliminate half the administered dose.) For this study, pre-determined blood-draw time points will range from 0 hours, at time of administration of MK-0822 on Study Day 1, to 336 hours on Post-Study Day 15.


Original Secondary Outcome: Same as current

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: January 13, 2012
Date Started: February 2012
Date Completion:
Last Updated: July 17, 2015
Last Verified: July 2015