NCT02028065

A Study to Evaluate the Incidence of Hypersensitivity After Administration of Sugammadex in Healthy Participants (MK-8616-101)

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Incidence of Hypersensitivity After Repeated Single Dose Administration of Sugammadex (MK-8616) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 382 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the potential for hypersensitivity symptoms upon repeat exposure to sugammadex. Healthy participants will be randomized to one of three treatment arms: sugammadex 4 mg/kg, sugammadex 16 mg/kg or placebo. Participants will receive 3 single intravenous (IV) doses of their randomized treatment, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3. Participants will be confined at the study center from the day before each dose until completion of the 24-hour post dose assessments.

Conditions

• Hypersensitivity
• Anaphylaxis

Interventions

Type	Name	Description
DRUG	Sugammadex	Sugammadex 4 mg/kg or 16 mg/kg administered as a single IV bolus over 10 seconds
DRUG	Placebo	Placebo administered as a single IV bolus over 10 seconds

Timeline

• Start date: 2014-01-03
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2014-01-06
• Last updated: 2019-04-03
• Results posted: 2015-10-02