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Efficacy and Safety of Org 25969 Administered After Zemuron® (MK-8616-042)

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ClinicalTrials.gov Identifier: NCT03519867
Recruitment Status : Completed
First Posted : May 9, 2018
Results First Posted : January 31, 2019
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Neuromuscular Blockade
Interventions Drug: MK-8616
Drug: Zemuron®
Enrollment 50
Recruitment Details Adult participants of American Society of Anesthesiologists (ASA) Class 1-3 who were scheduled for surgery were recruited at 4 study sites in the US.
Pre-assignment Details  
Arm/Group Title 1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg 2) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg 3) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg 4) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg 5) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg 6) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg 7) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg 8) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg 9) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg 10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg
Hide Arm/Group Description Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced neuromuscular blockade (NMB) reached 1 to 2 PTCs. Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
Period Title: Overall Study
Started 6 7 [1] 6 4 5 5 4 5 4 4
Treated 5 6 5 3 5 4 4 4 3 4
Completed 3 4 5 3 5 2 3 4 3 4
Not Completed 3 3 1 1 0 3 1 1 1 0
Reason Not Completed
Adverse Event             1             1             0             0             0             0             0             0             0             0
Protocol Violation             0             0             0             0             0             1             0             0             0             0
Admin. of relaxant other than Zemuron®             0             0             0             0             0             0             1             0             0             0
Admin. of other reversal agent             1             1             0             0             0             1             0             0             0             0
Reason not provided             1             1             1             1             0             1             0             1             1             0
[1]
One participant randomized to receive MK-8616 8.0 mg/kg received MK-8616 0.8 mg/kg.
Arm/Group Title 1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg 2) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg 3) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg 4) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg 5) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg 6) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg 7) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg 8) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg 9) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg 10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg Total
Hide Arm/Group Description Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. Total of all reporting groups
Overall Number of Baseline Participants 5 6 5 3 5 4 4 4 3 4 43
Hide Baseline Analysis Population Description
Baseline characteristics are presented for all treated participants.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 6 participants 5 participants 3 participants 5 participants 4 participants 4 participants 4 participants 3 participants 4 participants 43 participants
48  (12) 49  (10) 52  (11) 58  (20) 53  (14) 58  (11) 47  (12) 51  (4) 48  (17) 50  (10) 51  (11)
[1]
Measure Analysis Population Description: All treated participants.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 5 participants 3 participants 5 participants 4 participants 4 participants 4 participants 3 participants 4 participants 43 participants
Female
2
  40.0%
3
  50.0%
2
  40.0%
1
  33.3%
3
  60.0%
2
  50.0%
2
  50.0%
2
  50.0%
1
  33.3%
3
  75.0%
21
  48.8%
Male
3
  60.0%
3
  50.0%
3
  60.0%
2
  66.7%
2
  40.0%
2
  50.0%
2
  50.0%
2
  50.0%
2
  66.7%
1
  25.0%
22
  51.2%
[1]
Measure Analysis Population Description: All treated participants.
1.Primary Outcome
Title Time From Start of Administration of MK-8616 to Recovery T4/T1 Ratio to 0.9
Hide Description The mean time from the start of MK-8616 administration to recovery T4/T1 ratio of 0.9 was determined. Less time indicates faster recovery from NMB. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four [TOF] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX.
Time Frame Up to 90 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received ≥1 dose of study drug, had ≥1 post baseline efficacy measurement, and did not have any important protocol violations are included.
Arm/Group Title 1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg 2) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg 3) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg 4) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg 5) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg 6) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg 7) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg 8) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg 9) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg 10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg
Hide Arm/Group Description:
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
Overall Number of Participants Analyzed 3 2 5 2 4 1 3 3 2 4
Mean (Standard Deviation)
Unit of Measure: Minutes
44.18  (34.63) 19.08  (19.98) 5.38  (5.57) 3.32  (1.63) 1.53  (0.60) 20.57  (0) 11.52  (11.63) 4.33  (0.52) 1.92  (0.65) 0.98  (0.18)
2.Secondary Outcome
Title Percentage of Participants Experiencing ≥1 Adverse Events (AEs)
Hide Description The percentage of participants experiencing ≥1 AEs was determined. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment.
Time Frame Up to 7 days following MK-8616 administration
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received a dose of study treatment are included.
Arm/Group Title 1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg 2) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg 3) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg 4) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg 5) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg 6) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg 7) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg 8) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg 9) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg 10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg
Hide Arm/Group Description:
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
Overall Number of Participants Analyzed 5 6 5 3 5 4 4 4 3 4
Measure Type: Number
Unit of Measure: Percentage of Participants
100.0 100.0 60.0 66.7 80.0 100.0 100.0 100.0 66.7 50.0
Time Frame Up to 7 days
Adverse Event Reporting Description An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
 
Arm/Group Title 1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg 2) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg 3) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg 4) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg 5) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg 6) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg 7) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg 8) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg 9) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg 10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg
Hide Arm/Group Description Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs. Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
All-Cause Mortality
1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg 2) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg 3) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg 4) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg 5) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg 6) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg 7) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg 8) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg 9) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg 10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)      0/6 (0.00%)      0/5 (0.00%)      0/3 (0.00%)      0/5 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      0/3 (0.00%)      0/4 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg 2) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg 3) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg 4) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg 5) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg 6) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg 7) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg 8) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg 9) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg 10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/5 (20.00%)      0/6 (0.00%)      0/5 (0.00%)      1/3 (33.33%)      1/5 (20.00%)      0/4 (0.00%)      0/4 (0.00%)      1/4 (25.00%)      0/3 (0.00%)      0/4 (0.00%)    
Injury, poisoning and procedural complications                     
Postoperative fever  1  1/5 (20.00%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Procedural complication  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Investigations                     
Oxygen saturation decreased  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Psychiatric disorders                     
Delirium  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                     
Respiratory depression  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Vascular disorders                     
Hypotension  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
1
Term from vocabulary, MedDRA 08.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg 2) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg 3) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg 4) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg 5) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg 6) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg 7) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg 8) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg 9) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg 10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/5 (100.00%)      6/6 (100.00%)      3/5 (60.00%)      1/3 (33.33%)      4/5 (80.00%)      4/4 (100.00%)      4/4 (100.00%)      4/4 (100.00%)      2/3 (66.67%)      2/4 (50.00%)    
Blood and lymphatic system disorders                     
Anaemia  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Cardiac disorders                     
Bradycardia  1  1/5 (20.00%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  2
Sinus tachycardia  1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Tachycardia  1  0/5 (0.00%)  0 0/6 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  2 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Ventricular extrasystoles  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Gastrointestinal disorders                     
Flatulence  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Nausea  1  2/5 (40.00%)  2 3/6 (50.00%)  4 2/5 (40.00%)  3 1/3 (33.33%)  1 0/5 (0.00%)  0 2/4 (50.00%)  2 1/4 (25.00%)  1 3/4 (75.00%)  3 2/3 (66.67%)  2 1/4 (25.00%)  1
Vomiting  1  0/5 (0.00%)  0 1/6 (16.67%)  1 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  2 1/4 (25.00%)  1 0/4 (0.00%)  0 2/3 (66.67%)  2 0/4 (0.00%)  0
General disorders                     
Catheter site related reaction  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Chills  1  0/5 (0.00%)  0 0/6 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Oedema peripheral  1  0/5 (0.00%)  0 2/6 (33.33%)  2 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Pyrexia  1  0/5 (0.00%)  0 0/6 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Injury, poisoning and procedural complications                     
Airway complication of anaesthesia  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Operative haemorrhage  1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Post procedural nausea  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 1/4 (25.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Post procedural pain  1  2/5 (40.00%)  2 2/6 (33.33%)  3 2/5 (40.00%)  2 1/3 (33.33%)  1 3/5 (60.00%)  3 2/4 (50.00%)  2 2/4 (50.00%)  2 2/4 (50.00%)  3 1/3 (33.33%)  1 2/4 (50.00%)  2
Post procedural vomiting  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Investigations                     
Beta 2 microglobulin increased  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 2/5 (40.00%)  2 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Beta-N-acetyl-D-glucosaminidase increased  1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Blood albumin decreased  1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Blood creatine phosphokinase increased  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Blood glucose increased  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Electrocardiogram QT prolonged  1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Haematocrit decreased  1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Haemoglobin decreased  1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Oxygen saturation decreased  1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 1/4 (25.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Protein total decreased  1  0/5 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
White blood cell count increased  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Metabolism and nutrition disorders                     
Hyperkalaemia  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Hypocalcaemia  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Hypomagnesaemia  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Musculoskeletal and connective tissue disorders                     
Pain in extremity  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0
Nervous system disorders                     
Dizziness  1  0/5 (0.00%)  0 0/6 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Headache  1  1/5 (20.00%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Neuromuscular blockade  1  1/5 (20.00%)  1 1/6 (16.67%)  1 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Stupor  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Psychiatric disorders                     
Agitation  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Restlessness  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1 1/4 (25.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Renal and urinary disorders                     
Bladder discomfort  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1
Haematuria  1  0/5 (0.00%)  0 0/6 (0.00%)  0 1/5 (20.00%)  1 0/3 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Reproductive system and breast disorders                     
Genital burning sensation  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Vaginal haemorrhage  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                     
Dyspnoea  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
Vascular disorders                     
Hypertension  1  0/5 (0.00%)  0 2/6 (33.33%)  2 0/5 (0.00%)  0 1/3 (33.33%)  1 0/5 (0.00%)  0 1/4 (25.00%)  1 1/4 (25.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1
Hypotension  1  0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/3 (0.00%)  0 2/5 (40.00%)  2 1/4 (25.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0
1
Term from vocabulary, MedDRA 08.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Organon recognizes the right of the investigator(s) to publish, but all publications must be based on data validated by Organon. Any such scientific paper, presentation, or other communication concerning the clinical trial described in this protocol will first be submitted to Organon, at least six weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03519867     History of Changes
Other Study ID Numbers: P06387
MK-8616-042 ( Other Identifier: Merck Protocol Number )
19.4.204 ( Other Identifier: Organon Protocol Number )
First Submitted: May 8, 2018
First Posted: May 9, 2018
Results First Submitted: August 30, 2018
Results First Posted: January 31, 2019
Last Update Posted: January 31, 2019