drugset / Trial / NCT01512667

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

NCT01512667

Phase 1 Completed 25 enrolled Merck Sharp & Dohme LLC
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2012-01-17
Primary completion
2012-08-22
Completion
2012-08-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Odanacatib Small molecule 50 mg Oral