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Efficacy and Safety of Org 25969 Administered After Zemuron® (MK-8616-042)

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 2

Conditions

Neuromuscular Blockade

Treatments

Drug: MK-8616
Drug: Zemuron®

Study type

Interventional

Funder types

Industry

Identifiers

NCT03519867
19.4.204 (Other Identifier)
P06387
MK-8616-042 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 that would impede intubation
  • Has or is suspected to have neuromuscular disorders impairing neuromuscular block and/or significant renal dysfunction
  • Is known or suspected to have a family history of malignant hyperthermia
  • Is known or suspected to have an allergy to narcotics, muscle relaxants, or other medications used during general anesthesia
  • Is pregnant
  • Is a female of childbearing potential not using 1 of the following methods of birth control: condom or diaphragm with spermicide, vasectomized partner (<6 months), intrauterine device (IUD), or abstinence
  • Is breast-feeding
  • Has already participated in the study
  • Has participated in another clinical trial, not pre-approved by Organon Pharmaceuticals USA within 30 days of entering this study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 10 patient groups

1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg
Experimental group
Description:
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.
Treatment:
Drug: Zemuron®
Drug: MK-8616
2) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg
Experimental group
Description:
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.
Treatment:
Drug: Zemuron®
Drug: MK-8616
3) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg
Experimental group
Description:
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.
Treatment:
Drug: Zemuron®
Drug: MK-8616
4) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg
Experimental group
Description:
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.
Treatment:
Drug: Zemuron®
Drug: MK-8616
5) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg
Experimental group
Description:
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.
Treatment:
Drug: Zemuron®
Drug: MK-8616
6) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg
Experimental group
Description:
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.
Treatment:
Drug: Zemuron®
Drug: MK-8616
7) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg
Experimental group
Description:
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.
Treatment:
Drug: Zemuron®
Drug: MK-8616
8) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg
Experimental group
Description:
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.
Treatment:
Drug: Zemuron®
Drug: MK-8616
9) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg
Experimental group
Description:
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.
Treatment:
Drug: Zemuron®
Drug: MK-8616
10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg
Experimental group
Description:
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.
Treatment:
Drug: Zemuron®
Drug: MK-8616

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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