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).

NCT ID: NCT03519854

Last Updated: 2019-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-01
• Study Completion Date: 2003-06-01

Brief Summary

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®.

Conditions

Neuromuscular Blockade

Study Design

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

Study Groups

Arm A. Placebo; given 3 minutes after Esmeron®

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

0.9% NaCl administered as a fast IV bolus dose (within 30 seconds).

Esmeron®

Intervention Type: DRUG

Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.

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

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

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: DRUG

Sugammadex administered as a fast IV bolus dose (within 30 seconds), dosed according to participant actual body weight.

Esmeron®

Intervention Type: DRUG

Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.

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

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

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: DRUG

Sugammadex administered as a fast IV bolus dose (within 30 seconds), dosed according to participant actual body weight.

Esmeron®

Intervention Type: DRUG

Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.

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

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

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: DRUG

Sugammadex administered as a fast IV bolus dose (within 30 seconds), dosed according to participant actual body weight.

Esmeron®

Intervention Type: DRUG

Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.

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

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

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: DRUG

Sugammadex administered as a fast IV bolus dose (within 30 seconds), dosed according to participant actual body weight.

Esmeron®

Intervention Type: DRUG

Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.

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

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

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: DRUG

Sugammadex administered as a fast IV bolus dose (within 30 seconds), dosed according to participant actual body weight.

Esmeron®

Intervention Type: DRUG

Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.

Arm G. Placebo; given 5 minutes after Esmeron®

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

0.9% NaCl administered as a fast IV bolus dose (within 30 seconds).

Esmeron®

Intervention Type: DRUG

Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.

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

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

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: DRUG

Sugammadex administered as a fast IV bolus dose (within 30 seconds), dosed according to participant actual body weight.

Esmeron®

Intervention Type: DRUG

Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.

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

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

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: DRUG

Sugammadex administered as a fast IV bolus dose (within 30 seconds), dosed according to participant actual body weight.

Esmeron®

Intervention Type: DRUG

Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.

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

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

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: DRUG

Sugammadex administered as a fast IV bolus dose (within 30 seconds), dosed according to participant actual body weight.

Esmeron®

Intervention Type: DRUG

Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.

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

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

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: DRUG

Sugammadex administered as a fast IV bolus dose (within 30 seconds), dosed according to participant actual body weight.

Esmeron®

Intervention Type: DRUG

Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.

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

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

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: DRUG

Sugammadex administered as a fast IV bolus dose (within 30 seconds), dosed according to participant actual body weight.

Esmeron®

Intervention Type: DRUG

Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.

Arm M. Placebo; given 15 minutes after Esmeron®

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

0.9% NaCl administered as a fast IV bolus dose (within 30 seconds).

Esmeron®

Intervention Type: DRUG

Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.

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

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

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: DRUG

Sugammadex administered as a fast IV bolus dose (within 30 seconds), dosed according to participant actual body weight.

Esmeron®

Intervention Type: DRUG

Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.

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

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

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: DRUG

Sugammadex administered as a fast IV bolus dose (within 30 seconds), dosed according to participant actual body weight.

Esmeron®

Intervention Type: DRUG

Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.

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

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

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: DRUG

Sugammadex administered as a fast IV bolus dose (within 30 seconds), dosed according to participant actual body weight.

Esmeron®

Intervention Type: DRUG

Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.

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

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

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: DRUG

Sugammadex administered as a fast IV bolus dose (within 30 seconds), dosed according to participant actual body weight.

Esmeron®

Intervention Type: DRUG

Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.

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

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

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: DRUG

Sugammadex administered as a fast IV bolus dose (within 30 seconds), dosed according to participant actual body weight.

Esmeron®

Intervention Type: DRUG

Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.

Interventions

Placebo

0.9% NaCl administered as a fast IV bolus dose (within 30 seconds).

Intervention Type: DRUG

Sugammadex

Sugammadex administered as a fast IV bolus dose (within 30 seconds), dosed according to participant actual body weight.

Intervention Type: DRUG

Esmeron®

Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.

Intervention Type: DRUG

Other Intervention Names

Org 25969; MK-8616; Bridion®.; Rocuronium bromide

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

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

Other Identifiers

MK-8616-020

Identifier Type: OTHER

Identifier Source: secondary_id

19.4.202

Identifier Type: OTHER

Identifier Source: secondary_id

P05940

Identifier Type: -

Identifier Source: org_study_id