Status:
COMPLETED
Sugammadex Hypersensitivity Study (Study P06042)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hypersensitivity
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 seve...
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 sympto...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 6 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2010
Estimated Enrollment :
448 Patients enrolled
Trial Details
Trial ID
NCT00988065
Start Date
September 6 2009
End Date
April 13 2010
Last Update
January 30 2019
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.