None listed
Conditions
Interventions
Product Name: Org 25969
Product Code: Org 25969
Pharmaceutical Form: Solution for injection
CAS Number: 343306-79-6
Current Sponsor code: Org 25969
Other descriptive name: per-6-(2-carboxyethylthio)-p
Sponsors
NV Organon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • ASA class 1 – 2, between the ages of 28 days and 65 years inclusive, but between the ages of 2 and 65 years inclusive for Germany and between the ages 6 and 65 years inclusive for Finland • Scheduled for general anesthesia with an anticipated duration of anesthesia of at least 60 minutes, without further need for muscle relaxation other than one single dose of 0.6 mg.kg-1 rocuronium • Scheduled for surgical procedures in the supine position • Subjects who, and/or whose parent(s) or legal guardian(s) have given written informed consent [or appropriate assent, if applicable] Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Known or suspected neuromuscular disorders impairing NMB and/or significant renal dysfunction, in Germany creatinine and blood urea nitrogen outside local reference ranges • Known or suspected to have a (family) history of malignant hyperthermia • Known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia • Use of medication expected to interfere with the rocuronium given in this trial, based on the dose and the time of administration • Pregnancy • Childbearing potential not using any of the following methods of birth control: condom or diaphragm with spermicide, vasectomized partner ( > 6 months), IUD, abstinence • Breast-feeding • Prior participation in any trial with Org 25969 • Participation in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into trial 19.4.306
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To explore the dose-response relation of Org 25969 given as a reversal agent at reappearance of T2 after 0.6 mg.kg-1 rocuronium in pediatric and adult subjects;Secondary Objective: • To explore the pharmacokinetics of Org 25969 in pediatric and adult subjects • To evaluate the safety of Org 25969 in pediatric and adult subjects;Primary end point(s): Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.9 | — |
Countries
Finland, Germany, United Kingdom
Outcome results
None listed