This study will investigate and compare pharmacokinetics of a single 50 mg dose of odanacatib administered to participants with impaired renal/kidney function to those of a healthy matched control group. The primary hypothesis is that plasma AUC0-∞ of odanacatib in participants with impaired renal function is similar to that in matched healthy participants following a single 50 mg oral dose.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
A single oral dose (50 mg tablet) of MK-0822 will be administered on Day 1 after an overnight fast.
Area Under the Concentration-time Curve of MK-0822 From Time 0 to Infinity (AUC0-∞) After Single Dose
For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of AUC0-∞ (Total AUC). AUC0-∞ is a measure of total drug exposure.
Time frame: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose
Maximum Concentration (Cmax) of MK-0822 After Single Dose
For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Cmax.
Time frame: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose
Time to Maximum Concentration (Tmax) of MK-0822 After Single Dose
For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Tmax.
Time frame: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose
Apparent Terminal Half-life (t1/2) of MK-0822 After Single Dose
For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of t1/2.
Time frame: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose
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