A Study to Evaluate the Incidence of Hypersensitivity After Administration of Sugammadex in Healthy Participants (MK-8616-101)
Status: | Completed |
---|---|
Conditions: | Hospital, Neurology |
Therapuetic Areas: | Neurology, Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 5/3/2014 |
Start Date: | January 2014 |
End Date: | June 2014 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
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
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.
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.
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
We found this trial at
4
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials