At a glance
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A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Incidence of Hypersensitivity After Repeated Single Dose Administrations of Sugammadex (SCH 900616) in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Placebo run-in dose, Sugammadex 4 mg/kg, and 2 other interventions for Hypersensitivity. Completed, enrolled 448 participants.
Detailed Summary
This trial was conducted to study the potential for hypersensitivity symptoms at the time of initial exposure to sugammadex and upon repeat exposure, since it was unknown whether the frequency or severity of hypersensitivity symptoms may worsen at repeat exposure over a prolonged period. In total 450 participants (all healthy subjects) were to be randomized to receive one of three study treatments: three repeated doses of either sugammadex 4 mg/kg, sugammadex 16 mg/kg, or placebo. Participants were to receive one dose of study treatment on Day 8, Day 36, and Day 78 of the study in order to determine the safety of each treatment dose.
Study Details
Timeline
Interventions
Single-blind placebo intravenous bolus injection on Day 1 of the study, 7 days prior to randomization
Sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study
Sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study
Placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study