NCT00988065

Sugammadex Hypersensitivity Study (Study P06042)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 448 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Hypersensitivity

Interventions

Type	Name	Description
DRUG	Placebo run-in dose	Single-blind placebo intravenous bolus injection on Day 1 of the study, 7 days prior to randomization
DRUG	Sugammadex 4 mg/kg	Sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study
DRUG	Sugammadex 16 mg/kg	Sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study
DRUG	Placebo	Placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study

Timeline

• Start date: 2009-09-06
• Primary completion: 2010-04-13
• Completion: 2010-04-13
• First posted: 2009-10-01
• Last updated: 2019-01-30
• Results posted: 2011-07-11