Clinical trial: A Study to Evaluate the Incidence of Hypersensitivity After Administration of Sugammadex in Healthy Participants (MK-8616-101) (NCT02028065)

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
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years

Patient description (medical language): A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago.  It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol.  Family history is significant for similar problems in his mother.  Vital signs are normal and the patient has no other medical conditions.  Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed.

Patient description (patient's own words): I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor.

Does the patient match the trial criteria? Contradiction