Mode
Text Size
Log in / Sign up
Phase 1 N=382 Randomized Triple-blind Treatment

A Study to Evaluate the Incidence of Hypersensitivity After Administration of Sugammadex in Healthy Participants (MK-8616-101)

Hypersensitivity · Anaphylaxis

Enrolled (actual)
382
Serious AEs
1.3%
Results posted
Oct 2015
Primary outcome: Primary: Percentage of Participants With Adjudicated Symptoms of Hypersensitivity — 1.3; 6.6; 9.5 percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
Sugammadex (Drug); Placebo (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Merck Sharp & Dohme LLC
Primary completion
Jul 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants With Adjudicated Symptoms of Hypersensitivity
1.3; 6.6; 9.5
SECONDARY
Percentage of Participants With Adjudicated Anaphylaxis
0.0; 0.0; 0.7

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02028065). 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.

Back to search