Conditions: Hepatic Insufficiency
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 17
Healthy volunteers: yes

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. The primary hypothesis is that plasma AUC0-∞ of odanacatib in participants with moderate hepatic insufficiency is similar to that in matched healthy participants following a single 50 mg oral dose.

Detailed description:

Arms:
arm 1: Single-dose administration of odanacatib 50 mg to participants with moderate hepatic insufficiency. arm 2: Single-dose administration of odanacatib 50 mg to healthy matched control participants.

Interventions: intervention 1: MK-0822
Intervention descriptions: intervention 1: A single oral dose (50 mg tablet) of MK 0822 will be administered on Day 1 after an overnight fast.

Protocol document: