MedTrace Logo

Sugammadex Hypersensitivity Study (Study P06042)

NCT00988065 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 448

Last updated 2019-01-30

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-06
Primary Completion
2010-04-13
Completion
2010-04-13

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00988065 on ClinicalTrials.gov