Overview

Sugammadex Hypersensitivity Study (Study P06042)

Status:
Completed
Trial end date:
2010-04-13
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.