This study will evaluate the efficacy, safety, and pharmacokinetics (PK) of sugammadex (MK-8616) for reversal of both moderate and deep neuromuscular blockade (NMB) in pediatric participants aged birth to \<2 years. The primary hypothesis of this study is that sugammadex is superior to neostigmine in reversing moderate NMB as measured by time to neuromuscular recovery.
Age range
1 Day – 2 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Part A: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0-inf) for Sugammadex
Timeframe: Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
Part A: Area Under the Plasma Concentration Time Curve up to the Interpolated Concentration at 1 Hour Post Dose (AUC0-1hr) for Sugammadex
Timeframe: Day 1: 2, 15, 30, and 60 minutes (1 hour) post-dose
Part A: Area Under the Plasma Concentration Time Curve up to the Interpolated Concentration at 4 Hours Post Dose (AUC0-4hr) for Sugammadex
Timeframe: Day 1: 2, 15, 30, 60, and 240 minutes (4 hours) post-dose
Part A: Maximum Plasma Concentration (Cmax) of Sugammadex
Timeframe: Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
Part A: Plasma Clearance (CL) of Sugammadex
Timeframe: Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
Part A: Apparent Volume of Distribution (Vd) for Sugammadex
Timeframe: Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
Apparent Volume of Distribution at Steady State (Vss) for Sugammadex
Timeframe: Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
Part A: Half-Life (t1/2) of Sugammadex in Plasma
Timeframe: Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
Part B: Time to Neuromuscular Recovery (TTNMR) In Reversal of Moderate Block
Timeframe: Within Day 1
Parts A and B: Percentage of Participants With Adverse Events (AEs) Up To 7 Days Post Administration of Study Medication
Timeframe: Up to Day 7