Conditions: Hypersensitivity Anaphylaxis
Keywords: reversal of neuromuscular blockade
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 382
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3 arm 2: Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3 arm 3: Administration of 3 single IV doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3

Interventions: intervention 1: Sugammadex intervention 2: Placebo
Intervention descriptions: intervention 1: Sugammadex 4 mg/kg or 16 mg/kg administered as a single IV bolus over 10 seconds intervention 2: Placebo administered as a single IV bolus over 10 seconds

Protocol document: