drugset / Trial / NCT03519867
Efficacy and Safety of Org 25969 Administered After Zemuron® (MK-8616-042)
RandomizedParallel-groupDouble-blindTreatment
Summary
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).
Timeline
- Start
- 2004-08-01
- Primary completion
- 2005-05-26
- Completion
- 2005-05-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rocuronium | Other / unclassified | 0.6 mg/kg | Intravenous |
| Subject | Rocuronium | Other / unclassified | 1.2 mg/kg | Intravenous |
| Subject | Sugammadex | Other / unclassified | 0.5 mg/kg | Intravenous |
| Subject | Sugammadex | Other / unclassified | 1 mg/kg | Intravenous |
| Subject | Sugammadex | Other / unclassified | 2 mg/kg | Intravenous |
| Subject | Sugammadex | Other / unclassified | 4 mg/kg | Intravenous |
| Subject | Sugammadex | Other / unclassified | 8 mg/kg | Intravenous |
Indications
No indication recorded.