Sugammadex Hypersensitivity Study (Study P06042)

Status Completed

Clinical Trial 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.

Clinical Trial Description

All subjects were to be admitted to the study center the day before each scheduled dose and were to leave the unit the morning of the day after each dose. In cases of suspected hypersensitivity symptoms, healthy subjects were to remain confined to the study center until all signs and symptoms regressed, the subject was stable, and the investigator considered it safe for the subject to leave the study center. Four sites participated in this trial. ;

Study Design

Related Conditions & MeSH terms

Hypersensitivity

Clinical Trial Details

NCT number	NCT00988065
Study type	Interventional
Source	Merck Sharp & Dohme Corp.
Contact
Status	Completed
Phase	Phase 1
Start date	September 6, 2009
Completion date	April 13, 2010

View Details

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