Phase 1
N=448
Sugammadex Hypersensitivity Study (Study P06042)
Hypersensitivity
Bottom Line
View on ClinicalTrials.gov: NCT00988065 ↗Enrolled (actual)
448
Serious AEs
0.7%
Results posted
Jul 2011
Primary outcome: Primary: The Percentage of Participants With Adjudicated Hypersensitivity Signs/Symptoms, for Each Sugammadex Dose Group and Placebo. — 0.7; 4.7; 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Placebo run-in dose (Drug); Sugammadex 4 mg/kg (Drug); Sugammadex 16 mg/kg (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Participants With Adjudicated Hypersensitivity Signs/Symptoms, for Each Sugammadex Dose Group and Placebo. |
0.7; 4.7; 0 | — |
| SECONDARY The Percentage of Participants With Adjudicated Anaphylaxis According to the Definition by Sampson et al., for Each Sugammadex Dose Group and Placebo. |
0; 0.7; 0 | — |
| SECONDARY The Percentage of Participants With Each of the 3 Levels of Diagnostic Certainty of Adjudicated Anaphylaxis According to the Definition by Rüggeberg et al., for Each Sugammadex Dose Group and Placebo. |
0; 0.7; 0; 0; 1.3; 0 | — |
| SECONDARY The Percentage of Participants With Adjudicated Hypersensitivity Signs/Symptoms After Each Randomized Dose of Study Treatment, for Each Sugammadex Dose Group and Placebo. |
0.7; 4.0; 0; 0.7; 1.5; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 18-55 years of age
- Serum tryptase <=11.4 mcg/L and fasting triglyceride levels within normal limits
- Safety laboratory tests and vital signs must have been within normal limits
- Screening electrocardiogram must have been clinically acceptable and parameters within normal limits
- Body Mass Index between 19 and 32 kg/m^2
- Females must have agreed to use contraceptives
- Other certain administrative criteria as described in the protocol
Exclusion Criteria
- Females who were pregnant or intending to become pregnant
- Subjects who would not be able to participate optimally in the study, in the opinion of the investigator
- Certain surgical or medical conditions, recent infections, or mental instability
- Positive test for certain drugs or history of alcohol or drug abuse
- Positive test for hepatitis B, hepatitis C, or Human Immunodeficiency Virus (HIV)
- Blood donation in the past 60 days
- A history of unexplained reaction or hypersensitivity reaction during previous surgery and/or anesthesia
- History of anaphylaxis from any cause, suspected history of hypersensitivity to cyclodextrins, or multiple drug hypersensitivities
- Heavy smoker
- Received certain medications in the past
- History of allergy, hypersensitivity, or intolerance to epinephrine at greater risk of developing adverse reactions after epinephrine administration
- Other certain administrative criteria as described in the protocol
Data sourced from ClinicalTrials.gov (NCT00988065). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.