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Label indication BRIDION ® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients undergoing surgery. BRIDION is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients undergoing surgery. ( 1 ) FDA label
Also known as BRIDION®, Sugammadex, Org 25969, SCH 900616, Bridion^TM
MK-8616 · 1 trial · 1 indication
The mean time from the start of MK-8616 administration to recovery T4/T1 ratio of 0.9 was determined. Less time indicates faster recovery from NMB. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four \[TOF\] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX.
| Arm | Type | Description |
|---|---|---|
| 1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg | EXPERIMENTAL | Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced neuromuscular blockade (NMB) reaches 1 to 2 PTCs. |
| 2) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg | EXPERIMENTAL | Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs. |
| 3) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg | EXPERIMENTAL | Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs. |
| 4) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg | EXPERIMENTAL | Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs. |
| 5) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg | EXPERIMENTAL | Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs. |
| 6) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg | EXPERIMENTAL | Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs. |
| 7) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg | EXPERIMENTAL | Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs. |
| 8) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg | EXPERIMENTAL | Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs. |
| 9) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg | EXPERIMENTAL | Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs. |
| 10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg | EXPERIMENTAL | Participants (ASA Class 1 to 3) will receive an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 will be administered once Zemuron®-induced NMB reaches 1 to 2 PTCs. |
| Name | Type | Description |
|---|---|---|
| MK-8616 | DRUG | MK-8616 will be administered at doses of 0.5, 1.0, 2.0, 4.0 and 8.0 mg/kg iv as a 30-second infusion. Doses are based on actual body weight. |
| Zemuron® | DRUG | Zemuron® (0.6 or 1.2 mg/kg, iv) will be administered as a 10-second bolus infusion to achieve 1 to 2 PTCs. If needed, a maintenance dose of 0.15 mg/kg will be given. Doses are based on actual body weight. |
Inclusion Criteria: * Has an ASA Class of 1 to 3 * Is scheduled for surgical procedures (excluding dental and neck surgeries) with an anticipated duration of anesthesia of ≥45 minutes with the use of Zemuron® Exclusion Criteria: * Is undergoing dental or neck surgery * Has anatomical malformation...
MK-8616 is an investigational small molecule being studied for the reversal of neuromuscular blockade, a condition where muscle paralysis is induced during surgery. It is being developed by Merck & Company, Inc. (MRK) and has completed a Phase 2 clinical trial.
MK-8616 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is an investigational small molecule intended for use in neuromuscular blockade.
MK-8616 is in Phase 2 of clinical development. It has completed one Phase 2 trial, and the drug remains investigational, meaning it has not been approved by regulatory authorities and is still undergoing clinical evaluation.
MK-8616 has been studied in one completed Phase 2 clinical trial with the identifier NCT03519867. This trial, titled 'Efficacy and Safety of Org 25969 Administered After Zemuron® (MK-8616-042)', enrolled 50 participants and evaluated the drug in the context of neuromuscular blockade.
Yes, MK-8616 is also known as Org 25969. The clinical trial NCT03519867, which studied MK-8616, is titled 'Efficacy and Safety of Org 25969 Administered After Zemuron® (MK-8616-042)', confirming that both names refer to the same investigational drug.