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

Phase 2CompletedNCT03519867

Merck Sharp & Dohme LLC50 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Neuromuscular Blockade

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Has an ASA Class of 1 to 3 * Is scheduled for surgical procedures (excluding dental and neck surgeries) with an anticipated duration of anesthesia of ≥45 minutes with the use of Zemuron® Exclusion Criteria: * Is undergoing dental or neck surgery * Has anatomical malformation that would impede intubation * Has or is suspected to have neuromuscular disorders impairing neuromuscular block and/or significant renal dysfunction * Is known or suspected to have a family history of malignant hyperthermia * Is known or suspected to have an allergy to narcotics, muscle relaxants, or other medications used during general anesthesia * Is pregnant * Is a female of childbearing potential not using 1 of the following methods of birth control: condom or diaphragm with spermicide, vasectomized partner (\<6 months), intrauterine device (IUD), or abstinence * Is breast-feeding * Has already participated in the study * Has participated in another clinical trial, not pre-approved by Organon Pharmaceuticals USA within 30 days of entering this study

Outcomes

Primary Outcomes

Time From Start of Administration of MK-8616 to Recovery T4/T1 Ratio to 0.9

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

Secondary Outcomes

Percentage of Participants Experiencing ≥1 Adverse Events (AEs)

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