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).
A Multi-center, Randomized, Assessor-blinded, Placebo Controlled, Phase II, Parallel Dose-finding Trial in Male Subjects of ASA 1-2 to Assess the Efficacy, Safety and Pharmacokinetics of 5 Doses of Org 25969 When Administered After 0.6 mg.Kg-1 Esmeron® at 3, 5 or 15 Minutes
3 other identifiers
interventional
99
0 countries
N/A
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®.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2002
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
May 8, 2018
CompletedFirst Posted
Study publicly available on registry
May 9, 2018
CompletedResults Posted
Study results publicly available
February 1, 2019
CompletedApril 2, 2019
March 1, 2019
6 months
May 8, 2018
August 28, 2018
March 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9
Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.9 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.9 indicates faster recovery from NMB. Summary data, originally presented in the format of units "minutes:seconds" (mm:ss), was reformatted to be presented in the single unit of "minutes" (min).
Up to 70 minutes following administration of study treatment
Secondary Outcomes (7)
Mean Heart Rate at Baseline
Up to 45 minutes prior to study treatment administration
Mean Heart Rate at 2 Minutes Following Administration of Study Treatment
2 minutes following administration of study treatment
Mean Heart Rate at 30 Minutes Following Administration of Study Treatment
30 minutes following administration of study treatment
Mean Corrected QT Interval (QTc) at Baseline
Up to 45 minutes prior to study treatment administration
Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment
2 minutes following administration of study treatment
- +2 more secondary outcomes
Study Arms (18)
Arm A. Placebo; given 3 minutes after Esmeron®
PLACEBO COMPARATORPlacebo (single intravenous (IV) bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm B. 1 mg/kg Sugammadex; given 3 minutes after Esmeron®
EXPERIMENTALSugammadex (1 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm C. 2 mg/kg Sugammadex; given 3 minutes after Esmeron®
EXPERIMENTALSugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm D. 4 mg/kg Sugammadex; given 3 minutes after Esmeron®
EXPERIMENTALSugammadex (4 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm E. 6 mg/kg Sugammadex; given 3 minutes after Esmeron®
EXPERIMENTALSugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm F. 8 mg/kg Sugammadex; given 3 minutes after Esmeron®
EXPERIMENTALSugammadex (8 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm G. Placebo; given 5 minutes after Esmeron®
PLACEBO COMPARATORPlacebo (single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm H. 1 mg/kg Sugammadex; given 5 minutes after Esmeron®
EXPERIMENTALSugammadex (1 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm I. 2 mg/kg Sugammadex; given 5 minutes after Esmeron®
EXPERIMENTALSugammadex (2 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm J. 4 mg/kg Sugammadex; given 5 minutes after Esmeron®
EXPERIMENTALSugammadex (4 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm K. 6 mg/kg Sugammadex; given 5 minutes after Esmeron®
EXPERIMENTALSugammadex (6 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm L. 8 mg/kg Sugammadex; given 5 minutes after Esmeron®
EXPERIMENTALSugammadex (8 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm M. Placebo; given 15 minutes after Esmeron®
PLACEBO COMPARATORPlacebo (single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm N. 1 mg/kg Sugammadex; given 15 minutes after Esmeron®
EXPERIMENTALSugammadex (1 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm O. 2 mg/kg Sugammadex; given 15 minutes after Esmeron®
EXPERIMENTALSugammadex (2 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm P. 4 mg/kg Sugammadex; given 15 minutes after Esmeron®
EXPERIMENTALSugammadex (4 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm Q. 6 mg/kg Sugammadex; given 15 minutes after Esmeron®
EXPERIMENTALSugammadex (6 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Arm R. 8 mg/kg Sugammadex; given 15 minutes after Esmeron®
EXPERIMENTALSugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Interventions
0.9% NaCl administered as a fast IV bolus dose (within 30 seconds).
Sugammadex administered as a fast IV bolus dose (within 30 seconds), dosed according to participant actual body weight.
Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2018
First Posted
May 9, 2018
Study Start
December 1, 2002
Primary Completion
June 1, 2003
Study Completion
June 1, 2003
Last Updated
April 2, 2019
Results First Posted
February 1, 2019
Record last verified: 2019-03