Sugammadex Hypersensitivity Study (Study P06042)
Condition: Hypersensitivity
MeSH terms: Hypersensitivity
Intervention: Placebo run-in dose; Sugammadex 4 mg/kg; Sugammadex 16 mg/kg; Placebo
Intervention description: Single-blind placebo intravenous bolus injection on Day 1 of the study, 7 days prior to randomization; Sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study; Sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study; Placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 448.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

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