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

NCT ID: NCT02028065

Last Updated: 2019-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 382 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-03
• Study Completion Date: 2014-07-01

Brief 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.

Conditions

Hypersensitivity; Anaphylaxis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sugammadex 4 mg/kg

Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: DRUG

Sugammadex 4 mg/kg or 16 mg/kg administered as a single IV bolus over 10 seconds

Sugammadex 16 mg/kg

Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: DRUG

Sugammadex 4 mg/kg or 16 mg/kg administered as a single IV bolus over 10 seconds

Placebo

Administration of 3 single IV doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo administered as a single IV bolus over 10 seconds

Interventions

Sugammadex

Sugammadex 4 mg/kg or 16 mg/kg administered as a single IV bolus over 10 seconds

Intervention Type: DRUG

Placebo

Placebo administered as a single IV bolus over 10 seconds

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Min KC, Bondiskey P, Schulz V, Woo T, Assaid C, Yu W, Reynders T, Declercq R, McCrea J, Dennie J, Adkinson F, Shepherd G, Gutstein DE. Hypersensitivity incidence after sugammadex administration in healthy subjects: a randomised controlled trial. Br J Anaesth. 2018 Oct;121(4):749-757. doi: 10.1016/j.bja.2018.05.056. Epub 2018 Aug 23.

Reference Type: RESULT

PMID: 30236237 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

2013-004640-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

8616-101

Identifier Type: -

Identifier Source: org_study_id