Trial Outcomes & Findings for Pharmacokinetics of Sugammadex (MK-8616) in Participants With Moderate and Severe Renal Insufficiency (MK-8616-105) (NCT NCT02011490)
NCT ID: NCT02011490
Last Updated: 2018-10-02
Results Overview
Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. AUC0-∞ was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC0-last, determined by trapezoidal method) and the extrapolated area given by Cest,last/λz, where Cest,last is the estimated concentration corresponding to the time of the last measurable concentration and λz is the apparent first-order terminal elimination rate constant. For each subject, λz was calculated by regression of the terminal log-linear portion of the plasma concentration-time profile. The reported least squares mean is the geometric least squares mean, which is the back-transformed least squares mean from the analysis of variance (ANOVA) linear fixed-effect model performed on natural log-transformed values of AUC0-∞. This calculation also provides the associated 95% confidence interval.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
33 participants
Primary outcome timeframe
For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)
Results posted on
2018-10-02
Participant Flow
33 subjects participated in study. 9 participated in both Part 1 and Part 2; for these, separate Part 2 baseline assessments were obtained. Due to differing Part 1 and Part 2 baseline renal function result, 1 participant was in severe renal insufficiency group in Part 1 and moderate renal insufficiency group in Part 2.
Participant milestones
| Measure |
Severe Renal Insufficiency Participants: Part 1
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an intravenous (IV) bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Moderate Renal Insufficiency Participants: Part 1
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Healthy Control Participants: Part 1
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Severe Renal Insufficiency Participants: Part 2
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Moderate Renal Insufficiency Participants: Part 2
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Healthy Control Participants: Part 2
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
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|---|---|---|---|---|---|---|
|
Part 1
STARTED
|
8
|
8
|
8
|
0
|
0
|
0
|
|
Part 1
COMPLETED
|
8
|
8
|
8
|
0
|
0
|
0
|
|
Part 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2
STARTED
|
0
|
0
|
0
|
6
|
6
|
6
|
|
Part 2
COMPLETED
|
0
|
0
|
0
|
6
|
6
|
6
|
|
Part 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics of Sugammadex (MK-8616) in Participants With Moderate and Severe Renal Insufficiency (MK-8616-105)
Baseline characteristics by cohort
| Measure |
Severe Renal Insufficiency Participants: Part 1 + Part 2
n=10 Participants
This group includes participants with severe renal insufficiency who were included in Part 1, Part 2, or in both Part 1 and Part 2. Participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port.
|
Moderate Renal Insufficiency Participants: Part 1 + Part 2
n=11 Participants
This group includes participants with moderate renal insufficiency who were included in Part 1, Part 2, or in both Part 1 and Part 2. Participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port.
|
Healthy Control Participants: Part 1 + Part 2
n=12 Participants
This group includes healthy control participants who were included in Part 1, Part 2, or in both Part 1 and Part 2. Participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.3 Years
n=5 Participants
|
64.2 Years
n=7 Participants
|
58.3 Years
n=5 Participants
|
61.5 Years
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)Population: Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.
Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. AUC0-∞ was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC0-last, determined by trapezoidal method) and the extrapolated area given by Cest,last/λz, where Cest,last is the estimated concentration corresponding to the time of the last measurable concentration and λz is the apparent first-order terminal elimination rate constant. For each subject, λz was calculated by regression of the terminal log-linear portion of the plasma concentration-time profile. The reported least squares mean is the geometric least squares mean, which is the back-transformed least squares mean from the analysis of variance (ANOVA) linear fixed-effect model performed on natural log-transformed values of AUC0-∞. This calculation also provides the associated 95% confidence interval.
Outcome measures
| Measure |
Severe Renal Insufficiency Participants: Part 1
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Moderate Renal Insufficiency Participants: Part 1
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Healthy Control Participants: Part 1
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Severe Renal Insufficiency Participants: Part 2
n=6 Participants
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Moderate Renal Insufficiency Participants: Part 2
n=6 Participants
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Healthy Control Participants: Part 2
n=6 Participants
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
|---|---|---|---|---|---|---|
|
Geometric Least Squares Mean Area Under the Plasma Drug Concentration-time Curve From Time Zero to Infinity (AUC0-∞) Following a Single IV Dose of Sugammadex
|
—
|
—
|
—
|
339 ug*hr/mL
Interval 268.0 to 428.0
|
151 ug*hr/mL
Interval 120.0 to 191.0
|
62.5 ug*hr/mL
Interval 49.5 to 79.0
|
PRIMARY outcome
Timeframe: For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)Population: Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.
Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. AUC0-last was determined by trapezoidal method. The reported least squares mean is the geometric least squares mean, which is the back-transformed least squares mean from the ANOVA linear fixed-effect model performed on natural log-transformed values of AUC0-last. This calculation also provides the associated 95% confidence interval.
Outcome measures
| Measure |
Severe Renal Insufficiency Participants: Part 1
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Moderate Renal Insufficiency Participants: Part 1
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Healthy Control Participants: Part 1
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Severe Renal Insufficiency Participants: Part 2
n=6 Participants
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Moderate Renal Insufficiency Participants: Part 2
n=6 Participants
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Healthy Control Participants: Part 2
n=6 Participants
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
|---|---|---|---|---|---|---|
|
Geometric Least Squares Mean Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) Following a Single IV Dose of Sugammadex
|
—
|
—
|
—
|
335 ug*hr/mL
Interval 265.0 to 424.0
|
148 ug*hr/mL
Interval 117.0 to 187.0
|
61.1 ug*hr/mL
Interval 48.3 to 77.3
|
PRIMARY outcome
Timeframe: For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)Population: Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.
Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Cmax was determined from the observed plasma concentration-time data. The reported least squares mean is the geometric least squares mean, which is the back-transformed least squares mean from the ANOVA linear fixed-effect model performed on natural log-transformed values of Cmax. This calculation also provides the associated 95% confidence interval.
Outcome measures
| Measure |
Severe Renal Insufficiency Participants: Part 1
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Moderate Renal Insufficiency Participants: Part 1
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Healthy Control Participants: Part 1
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Severe Renal Insufficiency Participants: Part 2
n=6 Participants
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Moderate Renal Insufficiency Participants: Part 2
n=6 Participants
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Healthy Control Participants: Part 2
n=6 Participants
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
|---|---|---|---|---|---|---|
|
Geometric Least Squares Mean Maximum Observed Plasma Concentration (Cmax) Following a Single IV Dose of Sugammadex
|
—
|
—
|
—
|
62.2 ug/mL
Interval 50.2 to 77.1
|
60.6 ug/mL
Interval 49.0 to 75.1
|
66.1 ug/mL
Interval 53.3 to 81.8
|
PRIMARY outcome
Timeframe: For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)Population: Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.
Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. AUC%extrap represents the percentage of the AUC0-∞ obtained by extrapolation, calculated as (1 - \[AUC0-last/AUC0-∞\]) multiplied by 100.
Outcome measures
| Measure |
Severe Renal Insufficiency Participants: Part 1
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Moderate Renal Insufficiency Participants: Part 1
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Healthy Control Participants: Part 1
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Severe Renal Insufficiency Participants: Part 2
n=6 Participants
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Moderate Renal Insufficiency Participants: Part 2
n=6 Participants
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Healthy Control Participants: Part 2
n=6 Participants
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Percent of AUC0-∞ That Was Extrapolated (AUC%Extrap) Following a Single IV Dose of Sugammadex
|
—
|
—
|
—
|
0.850 Percent extrapolated
Geometric Coefficient of Variation 43.5
|
2.14 Percent extrapolated
Geometric Coefficient of Variation 29.2
|
2.10 Percent extrapolated
Geometric Coefficient of Variation 45.3
|
PRIMARY outcome
Timeframe: For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)Population: Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.
Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. CL is a quantitative measure of the rate at which a drug substance is removed from the body, calculated as Dose/AUC0-∞.
Outcome measures
| Measure |
Severe Renal Insufficiency Participants: Part 1
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Moderate Renal Insufficiency Participants: Part 1
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Healthy Control Participants: Part 1
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Severe Renal Insufficiency Participants: Part 2
n=6 Participants
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Moderate Renal Insufficiency Participants: Part 2
n=6 Participants
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Healthy Control Participants: Part 2
n=6 Participants
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Total Clearance (CL) Following a Single IV Dose of Sugammadex
|
—
|
—
|
—
|
0.961 L/hr
Geometric Coefficient of Variation 26.8
|
2.27 L/hr
Geometric Coefficient of Variation 39.6
|
5.70 L/hr
Geometric Coefficient of Variation 16.0
|
PRIMARY outcome
Timeframe: For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)Population: Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.
Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Vz was calculated as Dose/(AUC0-∞\*λz).
Outcome measures
| Measure |
Severe Renal Insufficiency Participants: Part 1
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Moderate Renal Insufficiency Participants: Part 1
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Healthy Control Participants: Part 1
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Severe Renal Insufficiency Participants: Part 2
n=6 Participants
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Moderate Renal Insufficiency Participants: Part 2
n=6 Participants
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Healthy Control Participants: Part 2
n=6 Participants
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Volume of Distribution During the Terminal Elimination Phase (Vz) Following a Single IV Dose of Sugammadex
|
—
|
—
|
—
|
18.3 L
Geometric Coefficient of Variation 24.8
|
18.8 L
Geometric Coefficient of Variation 24.2
|
20.4 L
Geometric Coefficient of Variation 25.7
|
PRIMARY outcome
Timeframe: For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)Population: Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.
Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. MRT is defined as the mean duration of time a drug molecule is present in the systemic circulation.
Outcome measures
| Measure |
Severe Renal Insufficiency Participants: Part 1
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Moderate Renal Insufficiency Participants: Part 1
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Healthy Control Participants: Part 1
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Severe Renal Insufficiency Participants: Part 2
n=6 Participants
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Moderate Renal Insufficiency Participants: Part 2
n=6 Participants
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Healthy Control Participants: Part 2
n=6 Participants
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
|---|---|---|---|---|---|---|
|
Geometric Mean of Mean Residence Time (MRT) of Unchanged Drug in the Systemic Circulation Following a Single IV Dose of Sugammadex
|
—
|
—
|
—
|
15.7 hr
Geometric Coefficient of Variation 26.2
|
7.02 hr
Geometric Coefficient of Variation 30.8
|
2.48 hr
Geometric Coefficient of Variation 13.4
|
PRIMARY outcome
Timeframe: For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)Population: Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.
Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Vss is the theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it is in blood plasma at steady state, calculated as CL\*MRT.
Outcome measures
| Measure |
Severe Renal Insufficiency Participants: Part 1
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Moderate Renal Insufficiency Participants: Part 1
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Healthy Control Participants: Part 1
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Severe Renal Insufficiency Participants: Part 2
n=6 Participants
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Moderate Renal Insufficiency Participants: Part 2
n=6 Participants
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Healthy Control Participants: Part 2
n=6 Participants
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Apparent Volume of Distribution Estimated at Steady-state (Vss) Following a Single IV Dose of Sugammadex
|
—
|
—
|
—
|
15.1 L
Geometric Coefficient of Variation 19.7
|
15.9 L
Geometric Coefficient of Variation 21.9
|
14.1 L
Geometric Coefficient of Variation 20.4
|
PRIMARY outcome
Timeframe: For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)Population: Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.
Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Tmax was determined from the observed plasma concentration-time data.
Outcome measures
| Measure |
Severe Renal Insufficiency Participants: Part 1
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Moderate Renal Insufficiency Participants: Part 1
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Healthy Control Participants: Part 1
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Severe Renal Insufficiency Participants: Part 2
n=6 Participants
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Moderate Renal Insufficiency Participants: Part 2
n=6 Participants
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Healthy Control Participants: Part 2
n=6 Participants
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
|---|---|---|---|---|---|---|
|
Median Time to Maximum Observed Plasma Concentration (Tmax) Following a Single IV Dose of Sugammadex
|
—
|
—
|
—
|
0.03 hr
Interval 0.03 to 0.08
|
0.03 hr
Interval 0.02 to 0.08
|
0.03 hr
Interval 0.03 to 0.08
|
PRIMARY outcome
Timeframe: For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)Population: Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.
Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Tlast was determined from the observed plasma concentration-time data.
Outcome measures
| Measure |
Severe Renal Insufficiency Participants: Part 1
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Moderate Renal Insufficiency Participants: Part 1
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Healthy Control Participants: Part 1
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Severe Renal Insufficiency Participants: Part 2
n=6 Participants
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Moderate Renal Insufficiency Participants: Part 2
n=6 Participants
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Healthy Control Participants: Part 2
n=6 Participants
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
|---|---|---|---|---|---|---|
|
Median Time of the Last Measurable Plasma Concentration (Tlast) Following a Single IV Dose of Sugammadex
|
—
|
—
|
—
|
72.00 hr
Interval 71.99 to 143.99
|
24.00 hr
Interval 23.99 to 47.99
|
12.00 hr
Interval 11.99 to 12.0
|
PRIMARY outcome
Timeframe: For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)Population: Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.
Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Elimination t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase, calculated as the natural log of 2 (ln\[2\])/λz.
Outcome measures
| Measure |
Severe Renal Insufficiency Participants: Part 1
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Moderate Renal Insufficiency Participants: Part 1
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Healthy Control Participants: Part 1
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Severe Renal Insufficiency Participants: Part 2
n=6 Participants
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Moderate Renal Insufficiency Participants: Part 2
n=6 Participants
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Healthy Control Participants: Part 2
n=6 Participants
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Apparent First-order Terminal Elimination Half-life (t1/2) Following a Single IV Dose of Sugammadex
|
—
|
—
|
—
|
13.24 hr
Geometric Coefficient of Variation 35.50
|
5.73 hr
Geometric Coefficient of Variation 29.79
|
2.47 hr
Geometric Coefficient of Variation 13.49
|
PRIMARY outcome
Timeframe: For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)Population: Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.
Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. t½eff was calculated as ln(2)\*MRT.
Outcome measures
| Measure |
Severe Renal Insufficiency Participants: Part 1
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Moderate Renal Insufficiency Participants: Part 1
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Healthy Control Participants: Part 1
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Severe Renal Insufficiency Participants: Part 2
n=6 Participants
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Moderate Renal Insufficiency Participants: Part 2
n=6 Participants
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Healthy Control Participants: Part 2
n=6 Participants
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Effective Half-life (t1/2eff) Following a Single IV Dose of Sugammadex
|
—
|
—
|
—
|
10.89 hr
Geometric Coefficient of Variation 26.15
|
4.87 hr
Geometric Coefficient of Variation 30.84
|
1.72 hr
Geometric Coefficient of Variation 13.36
|
PRIMARY outcome
Timeframe: For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)Population: Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.
Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. λz was calculated by regression of the terminal log-linear portion of the plasma concentration-time profile.
Outcome measures
| Measure |
Severe Renal Insufficiency Participants: Part 1
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Moderate Renal Insufficiency Participants: Part 1
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Healthy Control Participants: Part 1
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Severe Renal Insufficiency Participants: Part 2
n=6 Participants
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Moderate Renal Insufficiency Participants: Part 2
n=6 Participants
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Healthy Control Participants: Part 2
n=6 Participants
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Apparent First-order Terminal Elimination Rate Constant (λz) Following a Single IV Dose of Sugammadex
|
—
|
—
|
—
|
0.0524 1/hr
Geometric Coefficient of Variation 35.5
|
0.121 1/hr
Geometric Coefficient of Variation 29.8
|
0.280 1/hr
Geometric Coefficient of Variation 13.5
|
Adverse Events
Severe Renal Insufficiency Participants: Part 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Moderate Renal Insufficiency Participants: Part 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Healthy Control Participants: Part 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Severe Renal Insufficiency Participants: Part 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Moderate Renal Insufficiency Participants: Part 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Healthy Control Participants: Part 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Severe Renal Insufficiency Participants: Part 1
n=8 participants at risk
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Moderate Renal Insufficiency Participants: Part 1
n=8 participants at risk
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Healthy Control Participants: Part 1
n=8 participants at risk
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
|
Severe Renal Insufficiency Participants: Part 2
n=6 participants at risk
Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Moderate Renal Insufficiency Participants: Part 2
n=6 participants at risk
Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
Healthy Control Participants: Part 2
n=6 participants at risk
Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Paraesthesia oral
|
12.5%
1/8 • Number of events 1 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/8 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/8 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/6 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/6 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/6 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
|
General disorders
Injection site extravasation
|
0.00%
0/8 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
12.5%
1/8 • Number of events 1 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/8 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/6 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/6 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/6 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
|
General disorders
Injection site reaction
|
0.00%
0/8 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/8 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
12.5%
1/8 • Number of events 1 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/6 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/6 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/6 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/8 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
12.5%
1/8 • Number of events 1 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/8 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/6 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/6 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/6 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/8 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/8 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
12.5%
1/8 • Number of events 1 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/6 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/6 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/6 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/8 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/8 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/8 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/6 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
16.7%
1/6 • Number of events 1 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/6 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8 • Number of events 1 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/8 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/8 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/6 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/6 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/6 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/8 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/8 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/6 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/6 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/6 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/8 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/8 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
16.7%
1/6 • Number of events 1 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
16.7%
1/6 • Number of events 1 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/6 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
|
Nervous system disorders
Hypoaethesia
|
0.00%
0/8 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
12.5%
1/8 • Number of events 1 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/8 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/6 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/6 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
0.00%
0/6 • Up to Day 35 (Part 1) or Day 14 (Part 2)
33 subjects participated in study. 9 of these participated in both Part 1 and Part 2 and have adverse event data reported for both periods.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER