Clinical trial NCT03519854: 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).
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuromuscular Blockade
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2018-05-09
Enrollment: 99
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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®.


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.

Primary outcomes:
measure: Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9
timeFrame: Up to 70 minutes following administration of study treatment
Secondary outcomes:
measure: Mean Heart Rate at Baseline
timeFrame: Up to 45 minutes prior to study treatment administration
measure: Mean Heart Rate at 2 Minutes Following Administration of Study Treatment
timeFrame: 2 minutes following administration of study treatment
measure: Mean Heart Rate at 30 Minutes Following Administration of Study Treatment
timeFrame: 30 minutes following administration of study treatment
measure: Mean Corrected QT Interval (QTc) at Baseline
timeFrame: Up to 45 minutes prior to study treatment administration
measure: Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment
timeFrame: 2 minutes following administration of study treatment
measure: Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment
timeFrame: 30 minutes following administration of study treatment
measure: Number of Participants Experiencing an Adverse Event
timeFrame: Up to 7 days following administration of study treatment
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: