NCT01512693

Assessment of Pharmacokinetics of Single Dose Odanacatib (MK-0822) in Participants With Moderate Hepatic Insufficiency (MK-0822-070)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatic Insufficiency

Interventions

Type	Name	Description
DRUG	MK-0822	A single oral dose (50 mg tablet) of MK 0822 will be administered on Day 1 after an overnight fast.

Timeline

• Start date: 2012-02-23
• Primary completion: 2012-04-24
• Completion: 2012-04-24
• First posted: 2012-01-19
• Last updated: 2018-08-29
• Results posted: 2017-10-27

Regulatory

• FDA-regulated drug study