A Study to Evaluate the Incidence of Hypersensitivity After Administration of Sugammadex in Healthy Participants (MK-8616-101)
Condition: Hypersensitivity; Anaphylaxis
MeSH terms: Hypersensitivity; Anaphylaxis
Intervention: Sugammadex; Placebo
Intervention description: Sugammadex 4 mg/kg or 16 mg/kg administered as a single IV bolus over 10 seconds; Placebo administered as a single IV bolus over 10 seconds
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 382.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: reversal of neuromuscular blockade

Summary:

      The purpose of this study is to assess the potential for hypersensitivity symptoms upon
      repeat exposure to sugammadex. Healthy participants will be randomized to one of three
      treatment arms: sugammadex 4 mg/kg, sugammadex 16 mg/kg or placebo. Participants will receive
      3 single intravenous (IV) doses of their randomized treatment, with an approximately 5-week
      washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3. Participants will be
      confined at the study center from the day before each dose until completion of the 24-hour
      post dose assessments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant and non-breast feeding female

          -  Females of childbearing potential must have a serum β-human chorionic gonadotropin
             (β-hCG) level consistent with non-pregnant state and agree to use (and/or have their
             partner use) two acceptable methods of birth control beginning at screening,
             throughout the trial (including washout intervals between treatment periods) and until
             after the post-study follow-up visit

          -  Females not of childbearing potential must be either a) postmenopausal (have not had a
             menstrual period for at least 1 year and have a follicle stimulating hormone [FSH]
             value in the postmenopausal range) or b) surgically sterile (i.e., have had
             hysterectomy, oophorectomy or tubal ligation)

          -  In good health based on medical history, laboratory tests and other assessments

          -  Body Mass Index (BMI) ≥19 and ≤32 kg/m^2

          -  Non-smoker or smokes ≤10 cigarettes/day or equivalent (2 pipes/day, 1 cigar/day) and
             agrees not to smoke while confined at the study center

        Exclusion Criteria:

          -  Mentally or legally incapacitated, has significant emotional problems at the time of
             screening visit or expected during the conduct of the trial or has a history of
             clinically significant psychiatric disorder of the last 5 years

          -  History of clinically significant endocrine, gastrointestinal, cardiovascular,
             hematological, hepatic, immunological, renal, respiratory, genitourinary or major
             neurological abnormalities or diseases

          -  History of cancer (malignancy)

          -  History of significant multiple and/or severe allergies (e.g., food, drug, latex
             allergy), or has had an anaphylactic reaction or significant intolerability to
             prescription or non-prescription drugs or food

          -  Positive for hepatitis B surface antigen, hepatitis C antibodies or human
             immunodeficiency virus (HIV)

          -  Has had major surgery and/or donated or lost 1 unit of blood (approximately 500 mL)
             within 4 weeks prior to screening

          -  Has participated in another investigational trial within 4 weeks prior to screening

          -  Is unable to refrain from or anticipates the use of any medication, including
             prescription and non-prescription drugs or herbal remedies beginning approximately 2
             weeks prior to administration of the initial dose of trial drug, throughout the trial
             (including washout intervals between treatment periods), until the post-study
             follow-up visit

          -  Has received subcutaneous or sublingual immunotherapy within the past 1 year

          -  Consumes >3 glasses of alcoholic beverages per day

          -  Consumes excessive amounts, defined as >6 servings of coffee, tea, cola, energy
             drinks, or other caffeinated beverages per day

          -  Currently a regular user (including "recreational use") of any illicit drugs or has a
             history of drug (including alcohol) abuse within approximately 12 months

          -  Has a recollection of previously receiving sugammadex, Bridion™, SCH 900616, ORG
             25969, or MK-8616

          -  History of chronic urticaria or angioedema

          -  Is or has an immediate family member (spouse or children) who is a member of
             investigational site or sponsor staff directly involved with this trial