Trial Outcomes & Findings for Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics Subjects (NCT NCT00652028)
NCT ID: NCT00652028
Last Updated: 2017-04-13
Results Overview
Area under the concentration-time curve from time zero to the time of the last measurable concentration (AUC0-t) for Dexmedetomidine
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
69 participants
Primary outcome timeframe
≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.
Results posted on
2017-04-13
Participant Flow
Participant milestones
| Measure |
Dose Level 1
Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
|
Dose Level 2
Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
|
Dose Level 3
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
|
Dose Level 4
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
15
|
14
|
|
Overall Study
COMPLETED
|
15
|
13
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Dose Level 1
Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
|
Dose Level 2
Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
|
Dose Level 3
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
|
Dose Level 4
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
|
Overall Study
No Longer Meets Entry Criteria
|
0
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics Subjects
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=16 Participants
Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
|
Dose Level 2
n=14 Participants
Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
|
Dose Level 3
n=15 Participants
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
|
Dose Level 4
n=14 Participants
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
6.358 years
STANDARD_DEVIATION 3.4673 • n=5 Participants
|
7.457 years
STANDARD_DEVIATION 4.5990 • n=7 Participants
|
8.379 years
STANDARD_DEVIATION 4.4962 • n=5 Participants
|
7.462 years
STANDARD_DEVIATION 4.2259 • n=4 Participants
|
7.395 years
STANDARD_DEVIATION 4.1571 • n=21 Participants
|
|
Age, Customized
≥2 through <6 years
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
26 participants
n=21 Participants
|
|
Age, Customized
≥6 through <17 years
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
8 participants
n=4 Participants
|
33 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: ≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.Population: Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for pharmacokinetic (PK) and pharmacodynamic (PD) analyses.
Area under the concentration-time curve from time zero to the time of the last measurable concentration (AUC0-t) for Dexmedetomidine
Outcome measures
| Measure |
Dose Level 1
n=14 Participants
Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
|
Dose Level 2
n=13 Participants
Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
|
Dose Level 3
n=14 Participants
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
|
Dose Level 4
n=14 Participants
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC0-t)
|
2681.332 picograms*hr/mL
Standard Deviation 2353.3418
|
6460.576 picograms*hr/mL
Standard Deviation 3766.4657
|
16992.540 picograms*hr/mL
Standard Deviation 29927.3911
|
28531.864 picograms*hr/mL
Standard Deviation 17496.3985
|
PRIMARY outcome
Timeframe: ≤30 min prior to start of the loading dose (LD); 5 min before finishing the LD; 0.5,1,2&4 to 6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4&10 hrs after end of MI.Population: Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.
Area under the concentration-time curve from time zero to the time infinity (AUC0-∞) for Dexmedetomidine
Outcome measures
| Measure |
Dose Level 1
n=12 Participants
Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
|
Dose Level 2
n=13 Participants
Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
|
Dose Level 3
n=14 Participants
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
|
Dose Level 4
n=14 Participants
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to the Time Infinity (AUC0-∞)
|
3153.518 picograms*hr/mL
Standard Deviation 3343.3451
|
6673.163 picograms*hr/mL
Standard Deviation 3781.2183
|
17300.539 picograms*hr/mL
Standard Deviation 29935.7647
|
28970.541 picograms*hr/mL
Standard Deviation 17936.8970
|
PRIMARY outcome
Timeframe: ≤30 min prior to start of the loading dose (LD); 5 min before finishing the LD; 0.5,1,2&4 to 6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4&10 hrs after end of MI.Population: Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.
Observed peak plasma concentration (Cmax) for Dexmedetomidine
Outcome measures
| Measure |
Dose Level 1
n=14 Participants
Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
|
Dose Level 2
n=13 Participants
Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
|
Dose Level 3
n=14 Participants
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
|
Dose Level 4
n=14 Participants
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
|
|---|---|---|---|---|
|
Observed Peak Plasma Concentration
|
480.437 picograms per milliliter
Standard Deviation 625.9946
|
847.691 picograms per milliliter
Standard Deviation 633.7352
|
3385.569 picograms per milliliter
Standard Deviation 7384.0699
|
3090.939 picograms per milliliter
Standard Deviation 1625.5241
|
PRIMARY outcome
Timeframe: ≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.Population: Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.
Terminal elimination half-life (t1/2) for Dexmedetomidine
Outcome measures
| Measure |
Dose Level 1
n=12 Participants
Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
|
Dose Level 2
n=13 Participants
Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
|
Dose Level 3
n=14 Participants
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
|
Dose Level 4
n=14 Participants
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
|
|---|---|---|---|---|
|
Terminal Elimination Half-life (t1/2)
|
1.546 hour
Standard Deviation 0.3401
|
1.743 hour
Standard Deviation 0.3018
|
2.045 hour
Standard Deviation 0.6582
|
2.145 hour
Standard Deviation 0.6763
|
PRIMARY outcome
Timeframe: ≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.Population: Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.
Plasma concentration at steady state (Css) for Dexmedetomidine
Outcome measures
| Measure |
Dose Level 1
n=12 Participants
Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
|
Dose Level 2
n=13 Participants
Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
|
Dose Level 3
n=14 Participants
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
|
Dose Level 4
n=14 Participants
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
|
|---|---|---|---|---|
|
Plasma Concentration at Steady State (Css)
|
402.026 picograms per milliliter
Standard Deviation 535.1718
|
539.848 picograms per milliliter
Standard Deviation 166.7423
|
1347.284 picograms per milliliter
Standard Deviation 1308.0988
|
2827.144 picograms per milliliter
Standard Deviation 1169.4226
|
PRIMARY outcome
Timeframe: ≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.Population: Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.
Volume of steady state distribution (Vss) for Dexmedetomidine
Outcome measures
| Measure |
Dose Level 1
n=12 Participants
Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
|
Dose Level 2
n=13 Participants
Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
|
Dose Level 3
n=14 Participants
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
|
Dose Level 4
n=14 Participants
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
|
|---|---|---|---|---|
|
Volume of Steady State Distribution (Vss)
|
56.808 Litre
Standard Deviation 44.5127
|
35.246 Litre
Standard Deviation 25.0233
|
32.789 Litre
Standard Deviation 22.5478
|
43.652 Litre
Standard Deviation 30.6577
|
PRIMARY outcome
Timeframe: ≤30 min prior to start of loading dose (LD); 5 min before finishing LD; 0.5,1,2 & 4-6 hrs after start of maintenance infusion (MI); 30 min prior to end of MI (within 24 hrs of start of MI); 10 min after end of MI and 0.5,1,2,4 & 10 hrs after end of MI.Population: Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.
Clearance (CL) for Dexmedetomidine
Outcome measures
| Measure |
Dose Level 1
n=12 Participants
Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
|
Dose Level 2
n=13 Participants
Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
|
Dose Level 3
n=14 Participants
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
|
Dose Level 4
n=14 Participants
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
|
|---|---|---|---|---|
|
Clearance (CL)
|
32.208 Litre/hour
Standard Deviation 40.3982
|
20.268 Litre/hour
Standard Deviation 10.3508
|
18.565 Litre/hour
Standard Deviation 8.6995
|
22.199 Litre/hour
Standard Deviation 14.1623
|
PRIMARY outcome
Timeframe: Prior to loading (Baseline), 5 and 10 min during the load, at start of maintenance infusion and every 15 min for 1 hour, hourly during the maintenance period, before and within 5 min after midazolam or fentanyl dose during the dexmedetomidine infusion.Population: Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.
RSS Score range from 1 to 6: 1. Patient is anxious and agitated or restless, or both. 2. Patient is cooperative, orientated and tranquil. 3. Patient responds to command only. 4. Patient exhibits brisk response to light glabellar (between the eyebrows) tap or loud auditory stimulus. 5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus. 6. Patient exhibits no response to stimulus.
Outcome measures
| Measure |
Dose Level 1
n=15 Participants
Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
|
Dose Level 2
n=13 Participants
Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
|
Dose Level 3
n=14 Participants
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
|
Dose Level 4
n=14 Participants
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
|
|---|---|---|---|---|
|
Level of Sedation Based on Average Ramsay Sedation Scale (RSS) Score
|
2.4 units on a scale
Standard Deviation 0.96
|
2.8 units on a scale
Standard Deviation 0.74
|
2.4 units on a scale
Standard Deviation 0.5
|
4.0 units on a scale
Standard Deviation 1.04
|
PRIMARY outcome
Timeframe: During the treatment period (Approximately 24 hours)Population: Full Evaluable Population: Participants who received study drug infusion for at least 5 hours and had available PK data were included in the full evaluable population. This was the primary population for PK and PD analyses.
Number of subjects who received rescue medication for Sedation (Midazolam) and analgesics (Fentanyl) while intubated during Treatment Period
Outcome measures
| Measure |
Dose Level 1
n=16 Participants
Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
|
Dose Level 2
n=13 Participants
Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
|
Dose Level 3
n=14 Participants
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
|
Dose Level 4
n=14 Participants
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
|
|---|---|---|---|---|
|
Number of Subjects Who Received Rescue Medication for Sedation (Midazolam) and Analgesics (Fentanyl)
Midazolam
|
7 participants
|
7 participants
|
5 participants
|
3 participants
|
|
Number of Subjects Who Received Rescue Medication for Sedation (Midazolam) and Analgesics (Fentanyl)
Fentanyl
|
12 participants
|
10 participants
|
13 participants
|
8 participants
|
Adverse Events
Dose Level 1
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Dose Level 2
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Dose Level 3
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Dose Level 4
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Level 1
n=16 participants at risk
Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
|
Dose Level 2
n=14 participants at risk
Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
|
Dose Level 3
n=15 participants at risk
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
|
Dose Level 4
n=14 participants at risk
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
|
|---|---|---|---|---|
|
Nervous system disorders
Convulsion
|
6.2%
1/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
Other adverse events
| Measure |
Dose Level 1
n=16 participants at risk
Dexmedetomidine: Loading dose (IV) 0.25 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.2 mcg/kg/hour for 6-24 hours
|
Dose Level 2
n=14 participants at risk
Dexmedetomidine: Loading dose (IV) 0.5 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.4 mcg/kg/hour for 6-24 hours
|
Dose Level 3
n=15 participants at risk
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 0.7 mcg/kg/hour for 6-24 hours
|
Dose Level 4
n=14 participants at risk
Dexmedetomidine: Loading dose (IV) 1.0 mcg/kg/hour for 10 minutes; Continuous dose (IV infusion) 2.0 mcg/kg/hour for 6-24 hours
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
7.1%
1/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
13.3%
2/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
7.1%
1/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Cardiac disorders
Nodal rhythm
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
7.1%
1/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
7.1%
1/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
6.7%
1/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
7.1%
1/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
7.1%
1/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Eye disorders
Conjunctival haemorrhage
|
6.2%
1/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
6.7%
1/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
14.3%
2/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
6.7%
1/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
14.3%
2/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
28.6%
4/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
13.3%
2/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
14.3%
2/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
General disorders
Chills
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
6.7%
1/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
General disorders
Pain
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
7.1%
1/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
14.3%
2/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
General disorders
Pyrexia
|
25.0%
4/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
28.6%
4/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
13.3%
2/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
21.4%
3/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Infections and infestations
Serratia infection
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
6.7%
1/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
7.1%
1/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
6.2%
1/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
7.1%
1/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Injury, poisoning and procedural complications
Procedural pain
|
6.2%
1/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
14.3%
2/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
6.2%
1/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
6.7%
1/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
7.1%
1/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
6.7%
1/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Investigations
Blood urea increased
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
7.1%
1/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Investigations
Blood uric acid increased
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
7.1%
1/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Investigations
Cardiac enzymes increased
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
6.7%
1/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Investigations
Central venous pressure decreased
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
6.7%
1/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
6.7%
1/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Investigations
Neutrophil count increased
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
7.1%
1/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Investigations
Oxygen saturation decreased
|
6.2%
1/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Investigations
Urine output decreased
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
7.1%
1/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Investigations
White blood cell count increased
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
7.1%
1/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
7.1%
1/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
7.1%
1/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.2%
1/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
14.3%
2/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.2%
1/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
4/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
21.4%
3/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
6.7%
1/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
21.4%
3/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.2%
1/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
7.1%
1/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
7.1%
1/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
6.7%
1/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Nervous system disorders
Analgesia
|
6.2%
1/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Nervous system disorders
Sedation
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
21.4%
3/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Psychiatric disorders
Withdrawal syndrome
|
6.2%
1/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Renal and urinary disorders
Bladder distension
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
6.7%
1/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
7.1%
1/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Renal and urinary disorders
Ketonuria
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
7.1%
1/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
7.1%
1/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
13.3%
2/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
7.1%
1/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.2%
1/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
14.3%
2/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
6.7%
1/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
7.1%
1/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
6.2%
1/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
6.2%
1/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
14.3%
2/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
7.1%
1/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Vascular disorders
Hypertension
|
12.5%
2/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
14.3%
2/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
20.0%
3/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
21.4%
3/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
|
Vascular disorders
Hypotension
|
0.00%
0/16 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
7.1%
1/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
0.00%
0/15 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
7.1%
1/14 • From the start of study drug administration until 24 hours following discontinuation of study drug
|
Additional Information
Marcelo Garcia de Rocha MD, Global Medical Director
Hospira
Phone: 224-212-4424
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place