At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Sugammadex and Placebo for Hypersensitivity and Anaphylaxis. Completed, enrolled 382 participants.
Detailed 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.
Study Details
Timeline
Interventions
Sugammadex 4 mg/kg or 16 mg/kg administered as a single IV bolus over 10 seconds
Placebo administered as a single IV bolus over 10 seconds