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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT02028065
First received: January 3, 2014
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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. During each of Treatment Periods 1, 2 and 3, each participant will receive a single intravenous (IV) bolus injection of their randomized treatment while confined to the study center. In each Period, participants will remain at the study center until completion of the 24-hour post dose assessments. An approximately 5-week washout will be required between treatment periods.


Condition Intervention Phase
Hypersensitivity
Anaphylaxis
Drug: Sugammadex
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Incidence of Hypersensitivity After Repeated Single Dose Administration of Sugammadex (MK-8616) in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of participants with adjudicated symptoms of hypersensitivity [ Time Frame: Up to approximately 28 days after last dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of participants with adjudicated anaphylaxis [ Time Frame: Up to approximately 28 days after last dose ] [ Designated as safety issue: Yes ]

Enrollment: 383
Study Start Date: January 2014
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sugammadex 4 mg/kg
Single IV dose of sugammadex 4 mg/kg during each of Treatment Periods 1, 2 and 3 with an approximately 5-week washout between periods
Drug: Sugammadex
Sugammadex 4 mg/kg or 16 mg/kg administered as a single IV bolus over 10 seconds
Experimental: Sugammadex 16 mg/kg
Single IV dose of sugammadex 16 mg/kg during each of Treatment Periods 1, 2 and 3 with an approximately 5-week washout between periods
Drug: Sugammadex
Sugammadex 4 mg/kg or 16 mg/kg administered as a single IV bolus over 10 seconds
Placebo Comparator: Placebo
Single IV administration of placebo during each of Treatment Periods 1, 2 and 3 with an approximately 5-week washout between periods
Drug: Placebo
Placebo administered as a single IV bolus over 10 seconds

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02028065     History of Changes
Other Study ID Numbers: 8616-101, 2013-004640-37
Study First Received: January 3, 2014
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
reversal of neuromuscular blockade

Additional relevant MeSH terms:
Anaphylaxis
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2014