NCT02011490

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

Conditions

• Renal Insufficiency
• Renal Impairment

Interventions

Type	Name	Description
DRUG	sugammadex	sugammadex 4 mg/kg IV bolus

Timeline

• Start date: 2013-12-11
• Primary completion: 2014-06-06
• Completion: 2014-06-06
• First posted: 2013-12-13
• Last updated: 2018-10-02
• Results posted: 2015-02-10

Locations

1 site across 1 country: United States