a study to evaluate the incidence of hypersensitivity after administration of sugammadex in healthy participants (mk-8616-101)

Conditions: Hypersensitivity; Anaphylaxis

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

Keywords: reversal of neuromuscular blockade