Sugammadex Hypersensitivity Study (Study P06042)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Hypersensitivity

Treatments: Drug: Placebo run-in dose; Drug: Placebo; Drug: Sugammadex 4 mg/kg; Drug: Sugammadex 16 mg/kg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00988065

EUDRACT: 2009-012014-40

P06042

Details and patient eligibility

About

This trial was conducted to study the potential for hypersensitivity symptoms at the time of initial exposure to sugammadex and upon repeat exposure, since it was unknown whether the frequency or severity of hypersensitivity symptoms may worsen at repeat exposure over a prolonged period.

In total 450 participants (all healthy subjects) were to be randomized to receive one of three study treatments: three repeated doses of either sugammadex 4 mg/kg, sugammadex 16 mg/kg, or placebo. Participants were to receive one dose of study treatment on Day 8, Day 36, and Day 78 of the study in order to determine the safety of each treatment dose.

Full description

All subjects were to be admitted to the study center the day before each scheduled dose and were to leave the unit the morning of the day after each dose. In cases of suspected hypersensitivity symptoms, healthy subjects were to remain confined to the study center until all signs and symptoms regressed, the subject was stable, and the investigator considered it safe for the subject to leave the study center. Four sites participated in this trial.

Enrollment: 448 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18-55 years of age
• Serum tryptase <=11.4 mcg/L and fasting triglyceride levels within normal limits
• Safety laboratory tests and vital signs must have been within normal limits
• Screening electrocardiogram must have been clinically acceptable and parameters within normal limits
• Body Mass Index between 19 and 32 kg/m^2
• Females must have agreed to use contraceptives
• Other certain administrative criteria as described in the protocol

Exclusion criteria

• Females who were pregnant or intending to become pregnant
• Subjects who would not be able to participate optimally in the study, in the opinion of the investigator
• Certain surgical or medical conditions, recent infections, or mental instability
• Positive test for certain drugs or history of alcohol or drug abuse
• Positive test for hepatitis B, hepatitis C, or Human Immunodeficiency Virus (HIV)
• Blood donation in the past 60 days
• A history of unexplained reaction or hypersensitivity reaction during previous surgery and/or anesthesia
• History of anaphylaxis from any cause, suspected history of hypersensitivity to cyclodextrins, or multiple drug hypersensitivities
• Heavy smoker
• Received certain medications in the past
• History of allergy, hypersensitivity, or intolerance to epinephrine at greater risk of developing adverse reactions after epinephrine administration
• Other certain administrative criteria as described in the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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448 participants in 3 patient groups, including a placebo group

Sugammadex 4 mg/kg

Experimental group

Description:

Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.

Treatment:

Drug: Placebo run-in dose

Drug: Sugammadex 4 mg/kg

Sugammadex 16 mg/kg

Experimental group

Description:

Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.

Treatment:

Drug: Sugammadex 16 mg/kg

Drug: Placebo run-in dose

Placebo

Placebo Comparator group

Description:

Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.

Treatment:

Drug: Placebo

Drug: Placebo run-in dose