NCT01512667

Pharmacokinetic Assessment of Single-Dose Odanacatib (MK-0822) in Subjects With Severe Renal Insufficiency (MK-0822-067)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Renal 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: 2012-01-17
• Primary completion: 2012-08-22
• Completion: 2012-08-22
• First posted: 2012-01-19
• Last updated: 2018-08-28
• Results posted: 2018-02-26

Regulatory

• FDA-regulated drug study