Efficacy and Safety of Org 25969 Administered After Zemur... | NCT03519867

ID	Type	Description	Link
MK-8616-042	Other Identifier	Merck Protocol Number
19.4.204	Other Identifier	Organon Protocol Number

Efficacy and Safety of Org 25969 Administered After Zemur... | NCT03519867 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Drug: MK-8616 Drug: Zemuron®
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.	Drug: MK-8616 Drug: Zemuron®
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.	Drug: MK-8616 Drug: Zemuron®
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.	Drug: MK-8616 Drug: Zemuron®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.	1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time From Start of Administration of MK-8616 to Recovery T4/T1 Ratio to 0.9	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.	Up to 90 minutes

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Experiencing ≥1 Adverse Events (AEs)	The percentage of participants experiencing ≥1 AEs was determined. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment.	Up to 7 days following MK-8616 administration

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Arm/Group Information

ID	Title	Description
FG000	1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg	Participants (ASA Class 1 to 3) received 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 was administered once Zemuron®-induced neuromuscular blockade (NMB) reached 1 to 2 PTCs.
FG001	2) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg	Participants (ASA Class 1 to 3) received 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 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
FG002	3) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg	Participants (ASA Class 1 to 3) received 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 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
FG003	4) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg	Participants (ASA Class 1 to 3) received 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 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
FG004	5) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg	Participants (ASA Class 1 to 3) received 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 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
FG005	6) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg	Participants (ASA Class 1 to 3) received 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 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
FG006	7) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg	Participants (ASA Class 1 to 3) received 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 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
FG007	8) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg	Participants (ASA Class 1 to 3) received 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 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
FG008	9) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg	Participants (ASA Class 1 to 3) received 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 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
FG009	10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg	Participants (ASA Class 1 to 3) received 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 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG0006 subjects FG0017 subjectsOne participant randomized to receive MK-8616 8.0 mg/kg received MK-8616 0.8 mg/kg. FG0026 subjects FG0034 subjects FG0045 subjects FG0055 subjects FG0064 subjects FG0075 subjects FG0084 subjects FG0094 subjects
Treated		FG0005 subjects FG0016 subjects FG0025 subjects FG0033 subjects FG004
COMPLETED		FG0003 subjects FG0014 subjects FG0025 subjects FG0033 subjects FG004
NOT COMPLETED		FG0003 subjects FG0013 subjects FG0021 subjects FG0031 subjects FG004

Type	Comment	Reasons
Adverse Event		FG0001 subjects FG0011 subjects FG0020 subjects FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg	Participants (ASA Class 1 to 3) received 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 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
BG001	2) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous		All treated participants.

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time From Start of Administration of MK-8616 to Recovery T4/T1 Ratio to 0.9

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.

All randomized participants who received ≥1 dose of study drug, had ≥1 post baseline efficacy measurement, and did not have any important protocol violations are included.

Posted

Mean

Standard Deviation

Minutes

Up to 90 minutes

ID	Title	Description
OG000

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg	Participants (ASA Class 1 to 3) received 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 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Postoperative fever	Injury, poisoning and procedural complications	MedDRA 08.0	Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 08.0	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Senior Vice President, Global Clinical Development	Merck Sharp & Dohme Corp.	1-800-672-6372		ClinicalTrialsDisclosure@merck.com

Intervention Browse Module

ID	Term
D000077122	Sugammadex
D000077123	Rocuronium

ID	Term
D047408	gamma-Cyclodextrins
D003505	Cyclodextrins
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds

Sex: Female, Male

All treated participants.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	OG00044.18± 34.63 OG00119.08± 19.98 OG0025.38± 5.57 OG0033.32± 1.63 OG0041.53± 0.60 OG00520.57± 0 OG00611.52± 11.63 OG0074.33± 0.52 OG0081.92± 0.65 OG0090.98± 0.18

Secondary

Percentage of Participants Experiencing ≥1 Adverse Events (AEs)

The percentage of participants experiencing ≥1 AEs was determined. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment.

All participants who received a dose of study treatment are included.

Posted

Number

Percentage of Participants

Up to 7 days following MK-8616 administration

ID	Title	Description
OG000	1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg	Participants (ASA Class 1 to 3) received 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 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
OG001	2) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg	Participants (ASA Class 1 to 3) received 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 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
OG002	3) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg	Participants (ASA Class 1 to 3) received 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 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
OG003	4) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg	Participants (ASA Class 1 to 3) received 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 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
OG004	5) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg	Participants (ASA Class 1 to 3) received 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 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
OG005	6) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg	Participants (ASA Class 1 to 3) received 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 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
OG006	7) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg	Participants (ASA Class 1 to 3) received 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 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
OG007	8) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg	Participants (ASA Class 1 to 3) received 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 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
OG008	9) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg	Participants (ASA Class 1 to 3) received 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 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
OG009	10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg	Participants (ASA Class 1 to 3) received 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 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.

Units	Counts
Participants	OG0005 OG0016 OG0025 OG003

Title

Denominators