18 and older, any sex, with Neuromuscular Blockade. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time From Start of Administration of MK-8616 to Recovery T4/T1 Ratio to 0.9Primary· Up to 90 minutes
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
Group
Value
95% CI
1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg
44.18
± 34.63
2) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg
19.08
± 19.98
3) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg
5.38
± 5.57
4) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg
3.32
± 1.63
5) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg
1.53
± 0.60
6) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg
20.57
± 0
7) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg
11.52
± 11.63
8) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg
4.33
± 0.52
9) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg
1.92
± 0.65
10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg
0.98
± 0.18
Percentage of Participants Experiencing ≥1 Adverse Events (AEs)Secondary· Up to 7 days following MK-8616 administration
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.
Group
Value
95% CI
1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg
100.0
2) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg
100.0
3) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg
60.0
4) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg
66.7
5) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg
80.0
6) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg
100.0
7) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg
100.0
8) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg
100.0
9) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg
66.7
10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg
50.0
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 7 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The primary objective of this study is to explore the dose-response relation of MK-8616 (Org 25969) given as a reversal agent of Zemuron® at 1 to 2 post tetanic counts (PTCs); both Zemuron® and MK-8616 are administered by intravenous (iv) infusion. Another goal of the study is to evaluate the safety of single doses of MK-8616 administered to participants of American Society of Anesthesiologists (ASA) Physical Status Class 1 (otherwise normal, healthy participant); Class 2 (participant with a mild systemic disease); or Class 3 (participant with a severe systemic disease that limits activity, but is not incapacitating).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 31 January 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03519867.