Efficacy, Safety and Pharmacokinetics of Sugammadex (Org 25969; MK-8616) at 3 Different Time Points After 0.6 mg/kg Esmeron® in Male Participants (P05940; MK-8616-020).

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Neuromuscular Blockade

Treatments: Drug: Placebo; Drug: Sugammadex; Drug: Esmeron®

Study type: Interventional

Funder types: Industry

Identifiers

NCT03519854

19.4.202 (Other Identifier)

MK-8616-020 (Other Identifier)

P05940

Details and patient eligibility

About

This study investigates the efficacy, safety, and pharmacokinetics of sugammadex (Org 25969; MK-8616) when administered for the reversal of neuromuscular blockade in male participants receiving surgery, classified as American Society of Anesthesiologists (ASA) class 1 (otherwise normal, healthy participant) to class 2 (participant with mild systemic disease). The primary objective of this study is to explore the dose-response relation of sugammadex given as a reversal agent at 3, 5, or 15 minutes following administration of 0.6 mg/kg Esmeron®.

Enrollment: 99 patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants of ASA class 1 to 2.
• Participants scheduled for surgical procedures with an anticipated duration of anesthesia of at least 75 minutes, without further need for muscle relaxation other than for intubation.

Exclusion criteria

• Participants in whom a difficult intubation because of anatomical malformations is expected.
• Participants known or suspected to have neuromuscular disorders and/or significant hepatic or renal dysfunction.
• Participants known or suspected to have a (family) history of malignant hyperthermia.
• Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia.
• Participants receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, aminoglycosides, and Mg^2+.
• Participants who have already participated in this trial.
• Participants who have participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into this trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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99 participants in 18 patient groups, including a placebo group

Arm A. Placebo; given 3 minutes after Esmeron®

Placebo Comparator group

Description:

Placebo (single intravenous (IV) bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.

Treatment:

Drug: Esmeron®

Drug: Placebo

Arm B. 1 mg/kg Sugammadex; given 3 minutes after Esmeron®

Experimental group

Description:

Sugammadex (1 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.

Treatment:

Drug: Esmeron®

Drug: Sugammadex

Arm C. 2 mg/kg Sugammadex; given 3 minutes after Esmeron®

Experimental group

Description:

Sugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.

Treatment:

Drug: Esmeron®

Drug: Sugammadex

Arm D. 4 mg/kg Sugammadex; given 3 minutes after Esmeron®

Experimental group

Description:

Sugammadex (4 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.

Treatment:

Drug: Esmeron®

Drug: Sugammadex

Arm E. 6 mg/kg Sugammadex; given 3 minutes after Esmeron®

Experimental group

Description:

Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.

Treatment:

Drug: Esmeron®

Drug: Sugammadex

Arm F. 8 mg/kg Sugammadex; given 3 minutes after Esmeron®

Experimental group

Description:

Sugammadex (8 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.

Treatment:

Drug: Esmeron®

Drug: Sugammadex

Arm G. Placebo; given 5 minutes after Esmeron®

Placebo Comparator group

Description:

Placebo (single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.

Treatment:

Drug: Esmeron®

Drug: Placebo

Arm H. 1 mg/kg Sugammadex; given 5 minutes after Esmeron®

Experimental group

Description:

Sugammadex (1 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.

Treatment:

Drug: Esmeron®

Drug: Sugammadex

Arm I. 2 mg/kg Sugammadex; given 5 minutes after Esmeron®

Experimental group

Description:

Sugammadex (2 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.

Treatment:

Drug: Esmeron®

Drug: Sugammadex

Arm J. 4 mg/kg Sugammadex; given 5 minutes after Esmeron®

Experimental group

Description:

Sugammadex (4 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.

Treatment:

Drug: Esmeron®

Drug: Sugammadex

Arm K. 6 mg/kg Sugammadex; given 5 minutes after Esmeron®

Experimental group

Description:

Sugammadex (6 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.

Treatment:

Drug: Esmeron®

Drug: Sugammadex

Arm L. 8 mg/kg Sugammadex; given 5 minutes after Esmeron®

Experimental group

Description:

Sugammadex (8 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.

Treatment:

Drug: Esmeron®

Drug: Sugammadex

Arm M. Placebo; given 15 minutes after Esmeron®

Placebo Comparator group

Description:

Placebo (single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.

Treatment:

Drug: Esmeron®

Drug: Placebo

Arm N. 1 mg/kg Sugammadex; given 15 minutes after Esmeron®

Experimental group

Description:

Sugammadex (1 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.

Treatment:

Drug: Esmeron®

Drug: Sugammadex

Arm O. 2 mg/kg Sugammadex; given 15 minutes after Esmeron®

Experimental group

Description:

Sugammadex (2 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.

Treatment:

Drug: Esmeron®

Drug: Sugammadex

Arm P. 4 mg/kg Sugammadex; given 15 minutes after Esmeron®

Experimental group

Description:

Sugammadex (4 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.

Treatment:

Drug: Esmeron®

Drug: Sugammadex

Arm Q. 6 mg/kg Sugammadex; given 15 minutes after Esmeron®

Experimental group

Description:

Sugammadex (6 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.

Treatment:

Drug: Esmeron®

Drug: Sugammadex

Arm R. 8 mg/kg Sugammadex; given 15 minutes after Esmeron®

Experimental group

Description:

Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.

Treatment:

Drug: Esmeron®

Drug: Sugammadex