Pharmacokinetics of Sugammadex (MK-8616) in Participants With Moderate and Severe Renal Insufficiency (MK-8616-105)

Renal Insufficiency Clinical Trial

Official title: An Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of MK-8616 in Subjects With Moderate and Severe Renal Insufficiency

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the plasma pharmacokinetics of a single 4 mg/kg intravenous (IV) dose of sugammadex in participants with moderate and severe renal insufficiency compared to that in participants with normal renal function. The study consists of two parts. In Part 1, participants with renal insufficiency and healthy participants will be administered study drug by IV bolus injection into a peripheral vein. In Part 2, participants with renal insufficiency and healthy participants will be administered study drug as an IV bolus into a peripheral vein, through an IV catheter connected to IV tubing with injection port. Subjects who participate in Part 1 of study may be enrolled in Part 2, which would reduce the overall number of participants enrolled for the study.

Clinical Trial Description

In each study period (i.e., Part 1 and Part 2), day of drug administration was defined to be Day 1. ;

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

• NCT number: NCT02011490
• Study type: Interventional
• Source: Merck Sharp & Dohme Corp.
• Status: Completed
• Phase: Phase 1
• Start date: December 11, 2013
• Completion date: June 6, 2014