E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | Neuromuscular Blockade reversal | |
E.1.1.1 | Medical condition in easily understood language | Male/female participants between the ages of birth to <2 years undergoing clinical procedure requiring a neuromuscular blocking agent (rocuronium or vecuronium). | |
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 | E.1.2 | Level | PT | E.1.2 | Classification code | 10057286 | E.1.2 | Term | Neuromuscular blockade reversal | E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures | |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial | 1. To describe the pharmacokinetic parameters of sugammadex when used for reversal of moderate neuromuscular blockade (NMB) or deep NMB (Part A) 2. To evaluate the time to extubation of sugammadex in comparison to neostigmine for the reversal of moderate NMB (Part B) 3. To evaluate the safety and tolerability of sugammadex (data will be pooled across Part A and Part B of the study) | |
E.2.2 | Secondary objectives of the trial | 1. To evaluate the time to neuromuscular recovery of sugammadex in comparison to neostigmine for the reversal of moderate neuromuscular blockade (Part B). | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria | 1. Is categorized as ASA Physical Status Class 1, 2, or 3 as determined by the investigator 2. Has a planned non-emergent surgical procedure or clinical situation (eg, intubation) that requires moderate or deep NMB with either rocuronium or vecuronium 3. Has a surgical procedure or clinical situation that would allow neuromuscular monitoring techniques to be applied for neuromuscular transmission monitoring 4. Is male or female, between birth and <2 years of age at Visit 2 5. The legally acceptable representative for the study participant provides written informed consent/assent for the trial | |
E.4 | Principal exclusion criteria | 1. Is a preterm infant or neonate <36 weeks gestational age at birth 2. Has any clinically significant condition or situation (eg, anatomical malformation that complicates intubation) other than the condition requiring the use of NMBA that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial 3. Has a neuromuscular disorder that may affect NMB and/or trial assessments 4. Is dialysis-dependent or has (or is suspected of having) severe renal insufficiency (defined as estimated glomerular filtration rate [eGFR] <30 ml/min; using revised Schwartz estimate as method of calculation) 5. Has or is suspected of having a family or personal history of malignant hyperthermia 6. Has or is suspected of having an allergy to study treatments or its/their excipients, to opioids/opiates, muscle relaxants or their excipients, or other medication(s) used during general anesthesia 7. Is expected to require mechanical ventilation after the procedure 8. Has received or is planned to receive toremifene and/or fusidic acid via IV administration within 24 hours before or within 24 hours after administration of study treatment 9. Use of medication expected to interfere with study treatments given in this trial, as per prescribing information. Rocuronium or vecuronium are concomitant medications to be used per label as adjunct to general anesthesia. Besides rocuronium or vecuronium, a participant must not be administered any other NMBA during the trial, including: *Other steroidal NMBAs, such as pancuronium *Nonsteroidal NMBAs such as succinylcholine or benzylisoquinolinium compound (eg, cisatracurium). (Except in the circumstance that renewed muscle relaxation is needed after administration of study treatment, in which case a non-steroidal NMBA should be administered) 10. Has been previously treated with sugammadex or has participated in a sugammadex clinical trial 11. Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days of signing the informed consent/assent for this current trial 12. Is or has an immediate family member (eg, parent/legal guardian, or sibling) who is investigational site or Sponsor staff directly involved with this study | |
E.5 End points |
E.5.1 | Primary end point(s) | 1.Part A. Area Under the Plasma Concentration Time Curve (AUC) for Sugammadex 2.Part A. Plasma Clearance (CL) of Sugammadex 3.Part A. Apparent Volume of Distribution (Vz) for Sugammadex 4.Part A. Apparent Volume of Distribution at Steady State (Vss) for Sugammadex 5.Part A. Maximum Plasma Concentration (Cmax) of Sugammadex 6.Part A. Half-Life (t1/2) of Sugammadex in Plasma 7.Part B. Time to Extubation 8.Parts A and B. Number of Participants Experiencing an Adverse Event (AE) 9.Parts A and B. Number of Participants Discontinuing Study Due to an AE 10.Parts A and B. Number of Participants Experiencing Treatment-emergent Relative Bradycardia 11.Parts A and B. Number of Participants Experiencing Treatment-emergent Bradycardia | |
E.5.1.1 | Timepoint(s) of evaluation of this end point | 1.Baseline and 2, 15, 30, 60, 300, and 600 minutes post-dose 2.Baseline and 2, 15, 30, 60, 300, and 600 minutes post-dose 3.Baseline and 2, 15, 30, 60, 300, and 600 minutes post-dose 4.Baseline and 2, 15, 30, 60, 300, and 600 minutes post-dose 5.Baseline and 2, 15, 30, 60, 300, and 600 minutes post-dose 6.Baseline and 2, 15, 30, 60, 300, and 600 minutes post-dose 7.Up to 120 minutes post-dose 8.Up to 7 days 9.Up to 7 days 10.Up to 30 minutes post-dose 11.Up to 30 minutes post-dose | |
E.5.2 | Secondary end point(s) | 1.Part B. Time to Neuromuscular Recovery | |
E.5.2.1 | Timepoint(s) of evaluation of this end point | 1.Up to 120 minutes post-dose | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 | The trial involves single site in the Member State concerned | Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned | Australia | Belgium | Brazil | Denmark | Finland | France | Hungary | Malaysia | Netherlands | United States | |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial | |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |