Trial Outcomes & Findings for A PK/PD Study of Fospropofol Disodium Compared With Propofol Injectable Emulsion (NCT NCT01260142)
NCT ID: NCT01260142
Last Updated: 2017-01-27
Results Overview
AUC(0-inf) is a measure of drug concentration equal to the area under the plasma concentration-time profile from time 0 to infinity. An arterial line (A-line) and venous line (V-line) were placed prior to dosing during each treatment period and used to collect blood samples for plasma concentration measurements at specific time points. Plasma arterial and venous concentrations of fospropofol were quantified by high-performance liquid chromatography with mass spectrometric detection (LC-MS/MS). The AUC(0-inf) was calculated from the sum of AUC from time 0 to time t (AUC(0-t)) and the residual area calculated as Ct/λz, where Ct was the observed concentration at last quantifiable concentration and λz was the terminal elimination rate constant. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
36 participants
Primary outcome timeframe
Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).
Results posted on
2017-01-27
Participant Flow
Each cohort had 2 treatment periods that were separated by a 7 to 14 day washout: fospropofol disodium, followed by propofol injectable emulsion; or propofol injectable emulsion, followed by fospropofol disodium.
Participant milestones
| Measure |
Cohort 1 (Sequence A)
Participants were administered intravenous (IV) bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 0.65 mg/kg propofol injectable emulsion.
|
Cohort 1 (Sequence B)
Participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 6.5 mg/kg of fospropofol disodium.
|
Cohort 2 (Sequence C)
Participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.0 mg/kg propofol injectable emulsion.
|
Cohort 2 (Sequence D)
Participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 10 mg/kg of fospropofol disodium.
|
Cohort 3 (Sequence E)
Participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.5 mg/kg propofol injectable emulsion.
|
Cohort 3 (Sequence F)
Participants were administered an intravenous IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 15 mg/kg of fospropofol disodium.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Treatment Period 1
COMPLETED
|
5
|
5
|
6
|
6
|
4
|
3
|
|
Treatment Period 1
NOT COMPLETED
|
1
|
1
|
0
|
0
|
2
|
3
|
|
Treatment Period 2
STARTED
|
5
|
5
|
6
|
6
|
4
|
3
|
|
Treatment Period 2
COMPLETED
|
5
|
5
|
6
|
6
|
4
|
3
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 (Sequence A)
Participants were administered intravenous (IV) bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 0.65 mg/kg propofol injectable emulsion.
|
Cohort 1 (Sequence B)
Participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 6.5 mg/kg of fospropofol disodium.
|
Cohort 2 (Sequence C)
Participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.0 mg/kg propofol injectable emulsion.
|
Cohort 2 (Sequence D)
Participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 10 mg/kg of fospropofol disodium.
|
Cohort 3 (Sequence E)
Participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.5 mg/kg propofol injectable emulsion.
|
Cohort 3 (Sequence F)
Participants were administered an intravenous IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 15 mg/kg of fospropofol disodium.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1
Study on hold
|
1
|
1
|
0
|
0
|
1
|
2
|
|
Treatment Period 1
Unexplained elevated sys. BP
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Period 1
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A PK/PD Study of Fospropofol Disodium Compared With Propofol Injectable Emulsion
Baseline characteristics by cohort
| Measure |
Cohort 1 (Sequence A)
n=6 Participants
Participants were administered an intravenous (IV) bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 0.65 mg/kg propofol injectable emulsion.
|
Cohort 1 (Sequence B)
n=6 Participants
Participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 6.5 mg/kg of fospropofol disodium.
|
Cohort 2 (Sequence C)
n=6 Participants
Participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.0 mg/kg propofol injectable emulsion.
|
Cohort 2 (Sequence D)
n=6 Participants
Participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 10 mg/kg of fospropofol disodium.
|
Cohort 3 (Sequence E)
n=6 Participants
Participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.5 mg/kg propofol injectable emulsion.
|
Cohort 3 ( Sequence F)
n=6 Participants
Participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 15 mg/kg of fospropofol disodium.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
22.3 Years
STANDARD_DEVIATION 1.51 • n=5 Participants
|
25.5 Years
STANDARD_DEVIATION 3.78 • n=7 Participants
|
25.3 Years
STANDARD_DEVIATION 4.46 • n=5 Participants
|
22.7 Years
STANDARD_DEVIATION 2.88 • n=4 Participants
|
29 Years
STANDARD_DEVIATION 4.34 • n=21 Participants
|
23.8 Years
STANDARD_DEVIATION 3.37 • n=8 Participants
|
24.8 Years
STANDARD_DEVIATION 3.98 • n=8 Participants
|
|
Gender
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
|
Gender
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).Population: Pharmacokinetic (PK) Analysis Set is the group of participants who have sufficient pharmacokinetic data to derive at least one PK parameter.
AUC(0-inf) is a measure of drug concentration equal to the area under the plasma concentration-time profile from time 0 to infinity. An arterial line (A-line) and venous line (V-line) were placed prior to dosing during each treatment period and used to collect blood samples for plasma concentration measurements at specific time points. Plasma arterial and venous concentrations of fospropofol were quantified by high-performance liquid chromatography with mass spectrometric detection (LC-MS/MS). The AUC(0-inf) was calculated from the sum of AUC from time 0 to time t (AUC(0-t)) and the residual area calculated as Ct/λz, where Ct was the observed concentration at last quantifiable concentration and λz was the terminal elimination rate constant. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling.
Outcome measures
| Measure |
Fospropofol 6.5 mg/kg
n=10 Participants
Cohort 1: participants were administered an intravenous (IV) bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
|
Fospropofol 10 mg/kg
n=10 Participants
Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
|
Fospropofol 15 mg/kg
n=7 Participants
Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
|
Propofol 1.0 mg/kg
Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
|
Fospropofol 15 mg/kg
Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
|
Propofol 1.5 mg/kg
Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
|
|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of Fospropofol (AUC(0-inf))
|
16522 ug.h/L
Standard Deviation 3639.1
|
25052 ug.h/L
Standard Deviation 5923.8
|
36629 ug.h/L
Standard Deviation 5903.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).Population: PK Analysis Set
An A-line and V-line were placed prior to dosing during each treatment period and used to collect blood samples for plasma concentration measurements at specific time points. Plasma arterial and venous concentrations of propofol were quantified by high-performance liquid chromatography with mass spectrometric detection (LC-MS/MS). The AUC(0-inf) was calculated from the sum of AUC(0-t) and the residual area calculated as Ct/λz, where Ct was the observed concentration at last quantifiable concentration and λz was the terminal elimination rate constant. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling. In addition, the arterial plasma concentrations of fospropofol, propofol liberated from fospropofol, and propofol delivered from propofol injectable emulsion were used to refine the population PK model developed previously.
Outcome measures
| Measure |
Fospropofol 6.5 mg/kg
n=9 Participants
Cohort 1: participants were administered an intravenous (IV) bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
|
Fospropofol 10 mg/kg
n=5 Participants
Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
|
Fospropofol 15 mg/kg
n=7 Participants
Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
|
Propofol 1.0 mg/kg
n=5 Participants
Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
|
Fospropofol 15 mg/kg
n=4 Participants
Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
|
Propofol 1.5 mg/kg
n=4 Participants
Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
|
|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of Propofol
|
1541 ug.h/L
Standard Deviation 224.7
|
467 ug.h/L
Standard Deviation 88.3
|
2368 ug.h/L
Standard Deviation 435.3
|
661 ug.h/L
Standard Deviation 147.3
|
3807 ug.h/L
Standard Deviation 466.2
|
893 ug.h/L
Standard Deviation 127.7
|
PRIMARY outcome
Timeframe: Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).Population: PK Analysis Set
Arterial and venous blood samples were collected and analyzed for fospropofol concentrations as described previously. AUC(0-t) was calculated using the log-linear trapezoidal rule (linear trapezoidal rule up to maximum observed plasma concentration (Cmax), log trapezoidal rule following Cmax) from time of dosing to the last quantifiable concentration. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling.
Outcome measures
| Measure |
Fospropofol 6.5 mg/kg
n=10 Participants
Cohort 1: participants were administered an intravenous (IV) bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
|
Fospropofol 10 mg/kg
n=10 Participants
Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
|
Fospropofol 15 mg/kg
n=8 Participants
Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
|
Propofol 1.0 mg/kg
Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
|
Fospropofol 15 mg/kg
Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
|
Propofol 1.5 mg/kg
Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
|
|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC(0-t)) of Fospropofol
|
16046 ug.h/L
Standard Deviation 3439.6
|
24473 ug.h/L
Standard Deviation 5729.5
|
36330 ug.h/L
Standard Deviation 5488.7
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).Population: PK Analysis Set
Arterial and venous blood samples were collected and analyzed for propofol concentrations as described previously. AUC(0-t) was calculated using the log-linear trapezoidal rule (linear trapezoidal rule up to Cmax, log trapezoidal rule following Cmax) from time of dosing to the last quantifiable concentration. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling. In addition, the arterial plasma concentrations of fospropofol, propofol liberated from fospropofol, and propofol delivered from propofol injectable emulsion were used to refine the population PK model developed previously.
Outcome measures
| Measure |
Fospropofol 6.5 mg/kg
n=10 Participants
Cohort 1: participants were administered an intravenous (IV) bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
|
Fospropofol 10 mg/kg
n=10 Participants
Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
|
Fospropofol 15 mg/kg
n=10 Participants
Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
|
Propofol 1.0 mg/kg
n=10 Participants
Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
|
Fospropofol 15 mg/kg
n=8 Participants
Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
|
Propofol 1.5 mg/kg
n=8 Participants
Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
|
|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time 0 to Time t of Propofol
|
1343 ug.h/L
Standard Deviation 166.9
|
385 ug.h/L
Standard Deviation 84.5
|
2009 ug.h/L
Standard Deviation 413.9
|
578 ug.h/L
Standard Deviation 107.2
|
3019 ug.h/L
Standard Deviation 468.2
|
801 ug.h/L
Standard Deviation 141.6
|
PRIMARY outcome
Timeframe: Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).Population: PK Analysis Set
Arterial and venous blood samples were collected and analyzed for fospropofol concentrations as described previously. Cmax was the highest plasma drug concentration observed over the entire sampling period, and was obtained directly from the experimental plasma concentration time data without interpolation. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling.
Outcome measures
| Measure |
Fospropofol 6.5 mg/kg
n=10 Participants
Cohort 1: participants were administered an intravenous (IV) bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
|
Fospropofol 10 mg/kg
n=10 Participants
Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
|
Fospropofol 15 mg/kg
n=8 Participants
Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
|
Propofol 1.0 mg/kg
Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
|
Fospropofol 15 mg/kg
Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
|
Propofol 1.5 mg/kg
Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
|
|---|---|---|---|---|---|---|
|
Maximum Drug Plasma Concentration (Cmax) of Fospropofol
|
95.6 ug/mL
Standard Deviation 16.45
|
146.3 ug/mL
Standard Deviation 25.6
|
207.3 ug/mL
Standard Deviation 29.17
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).Population: PK Analysis Set
Arterial and venous blood samples were collected and analyzed for propofol concentrations as described previously. Cmax was the highest plasma drug concentration observed over the entire sampling period, and was obtained directly from the experimental plasma concentration time data without interpolation. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling.
Outcome measures
| Measure |
Fospropofol 6.5 mg/kg
n=10 Participants
Cohort 1: participants were administered an intravenous (IV) bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
|
Fospropofol 10 mg/kg
n=10 Participants
Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
|
Fospropofol 15 mg/kg
n=10 Participants
Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
|
Propofol 1.0 mg/kg
n=10 Participants
Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
|
Fospropofol 15 mg/kg
n=8 Participants
Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
|
Propofol 1.5 mg/kg
n=8 Participants
Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
|
|---|---|---|---|---|---|---|
|
Maximum Drug Plasma Concentration of Propofol
|
1.5 ug/mL
Standard Deviation 0.47
|
8 ug/mL
Standard Deviation 6
|
2.1 ug/mL
Standard Deviation 0.74
|
8.6 ug/mL
Standard Deviation 6.39
|
3.1 ug/mL
Standard Deviation 0.7
|
9.5 ug/mL
Standard Deviation 4.44
|
SECONDARY outcome
Timeframe: Days 1, and 7-14 (BIS measurements were to continue until the subject was fully recovered in the opinion of the investigator or until the PD effect measures returned to baseline measures)Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD assessment.
Pharmacodynamic (PD) effects were obtained from continuous BIS score recordings obtained throughout the study and from clinical assessment of sedation using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale. The BIS measurements continued until the participant was fully recovered in the opinion of the investigator or until the PD effect measure returned to baseline. The BIS score varied between 100 (associated with being fully awake) and 0 (associated with a flat line on the electroencephalogram (EEG)). The BIS Index was described by the maximal effect (Emax) model.
Outcome measures
| Measure |
Fospropofol 6.5 mg/kg
n=11 Participants
Cohort 1: participants were administered an intravenous (IV) bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
|
Fospropofol 10 mg/kg
n=11 Participants
Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
|
Fospropofol 15 mg/kg
n=12 Participants
Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
|
Propofol 1.0 mg/kg
n=12 Participants
Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
|
Fospropofol 15 mg/kg
n=9 Participants
Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
|
Propofol 1.5 mg/kg
n=10 Participants
Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
|
|---|---|---|---|---|---|---|
|
Maximal Sedative Effect Using the Bispectral Index (BIS) Score
|
70.2 Scores on a scale
Standard Deviation 10.3
|
81.5 Scores on a scale
Standard Deviation 8.12
|
55.4 Scores on a scale
Standard Deviation 11.35
|
65.8 Scores on a scale
Standard Deviation 15.17
|
38.6 Scores on a scale
Standard Deviation 7.78
|
49 Scores on a scale
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: Days 1, and 7-14 (2 minutes prior to study drug administration and every 2 minutes thereafter for 20 minutes or until the subject reached Fully Alert status, whichever was later).Population: PD Analysis Set
PD effects were determined from continuous BIS score recordings and from clinical assessment of sedation using the MOAA/S scale. The MOAA/S scale was used to rate the level of alertness/sedation from a score of 0 (does not respond to painful stimulus) to 5 (alert) in the category of responsiveness, with 5 being the MOAA/S value for a fully awake adult. Time to sedation was defined as the time from the first dose of study medication to the first two consecutive MOAA/S scores less than or equal to 4. Fully awake status was reached at the first of 3 consecutive MOAA/S scores of 5 measured every 2 minutes after study drug administration. The MOAA/S scale was described by the Emax model.
Outcome measures
| Measure |
Fospropofol 6.5 mg/kg
n=11 Participants
Cohort 1: participants were administered an intravenous (IV) bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
|
Fospropofol 10 mg/kg
n=11 Participants
Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
|
Fospropofol 15 mg/kg
n=12 Participants
Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
|
Propofol 1.0 mg/kg
n=12 Participants
Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
|
Fospropofol 15 mg/kg
n=9 Participants
Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
|
Propofol 1.5 mg/kg
n=10 Participants
Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
|
|---|---|---|---|---|---|---|
|
Maximal Sedative Effect Using the Modified Observer's Assessment of Alertness/Sedation Scale
|
4.1 Scores on a scale
Standard Deviation 1.58
|
4.7 Scores on a scale
Standard Deviation 0.65
|
2.8 Scores on a scale
Standard Deviation 1.64
|
3.9 Scores on a scale
Standard Deviation 1.44
|
0.3 Scores on a scale
Standard Deviation 0.71
|
1.7 Scores on a scale
Standard Deviation 1.57
|
SECONDARY outcome
Timeframe: Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).Population: PK Analysis Set
The PK parameters for propofol from propofol injectable emulsion were used as the reference formulation. Because propofol is a metabolite of fospropofol, all calculations were conducted after correcting for the different molecular weights of these formulations. Molecular weights of 332.24 (288.24 for free base) and 178.27 were used for fospropofol disodium and propofol injectable emulsion, respectively. The propofol parameters were adjusted as appropriate as discussed above and natural log transformed prior to comparison. Relative bioavailability of propofol from fospropofol disodium (E2083) to propofol from propofol injectable emulsion is calculated as (AUC(FP) x Total Dose of Propofol/AUC(P) x Total Dose of E2083) x Molecular fraction, where AUC(FP) is AUC(0-t) or AUC(0-inf) of propofol from E2083, AUC(P) is AUC(0-t) or AUC(0-inf) of propofol from propofol injectable emulsion and molecular fraction is molecular weight of propofol (178.27)/E2083 (332.24).
Outcome measures
| Measure |
Fospropofol 6.5 mg/kg
n=10 Participants
Cohort 1: participants were administered an intravenous (IV) bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
|
Fospropofol 10 mg/kg
n=10 Participants
Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
|
Fospropofol 15 mg/kg
n=7 Participants
Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
|
Propofol 1.0 mg/kg
Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
|
Fospropofol 15 mg/kg
Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
|
Propofol 1.5 mg/kg
Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
|
|---|---|---|---|---|---|---|
|
Relative Bioavailability of Fospropofol and Propofol
AUC(0-t)
|
0.684 ng x hr/mL
Standard Deviation 0.1505
|
0.661 ng x hr/mL
Standard Deviation 0.0987
|
0.713 ng x hr/mL
Standard Deviation 0.0671
|
—
|
—
|
—
|
|
Relative Bioavailability of Fospropofol and Propofol
AUC(0-inf)
|
0.694 ng x hr/mL
Standard Deviation 0.0882
|
0.68 ng x hr/mL
Standard Deviation 0.0495
|
0.836 ng x hr/mL
Standard Deviation 0.0198
|
—
|
—
|
—
|
Adverse Events
Fospropofol 6.5 mg/kg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Propofol 0.65 mg/kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Fospropofol 10 mg/kg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Propofol 1.0 mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Fospropofol 15 mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Propofol 1.5 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fospropofol 6.5 mg/kg
n=11 participants at risk
Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
|
Propofol 0.65 mg/kg
n=11 participants at risk
Cohort 1: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group B) or Treatment Period 2 (Sequence Group A).
|
Fospropofol 10 mg/kg
n=12 participants at risk
Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
|
Propofol 1.0 mg/kg
n=12 participants at risk
Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
|
Fospropofol 15 mg/kg
n=9 participants at risk
Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
|
Propofol 1.5 mg/kg
n=10 participants at risk
Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
|
|---|---|---|---|---|---|---|
|
General disorders
Feeling hot
|
0.00%
0/11 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/11 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
8.3%
1/12 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
8.3%
1/12 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/9 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/10 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
|
Nervous system disorders
Burning sensation
|
18.2%
2/11 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
9.1%
1/11 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/12 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
8.3%
1/12 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
11.1%
1/9 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/10 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
9.1%
1/11 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
8.3%
1/12 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
8.3%
1/12 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/9 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/10 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/11 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/11 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
8.3%
1/12 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/12 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/9 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/10 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
|
Nervous system disorders
Paraesthesia
|
9.1%
1/11 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/11 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
25.0%
3/12 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
8.3%
1/12 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
33.3%
3/9 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/10 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
|
Reproductive system and breast disorders
Genital burning sensation
|
0.00%
0/11 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/11 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
8.3%
1/12 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/12 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
11.1%
1/9 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/10 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
|
Reproductive system and breast disorders
Pruritus genital
|
9.1%
1/11 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/11 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/12 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/12 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
11.1%
1/9 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/10 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
18.2%
2/11 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/11 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
16.7%
2/12 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/12 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
11.1%
1/9 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
20.0%
2/10 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/11 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/11 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/12 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
8.3%
1/12 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/9 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/10 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
27.3%
3/11 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
27.3%
3/11 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
25.0%
3/12 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/12 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
11.1%
1/9 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/10 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/11 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/11 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
25.0%
3/12 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/12 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/9 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
0.00%
0/10 • An adverse event in Treatment Period 1 was counted up to 3 days after the first treatment; an adverse event in Treatment Period 2 was counted up to 3 days after the second treatment. Up to approximately 32 days.
A subject with 2 or more adverse events in the same System Organ Class was counted only once for that System Organ Class (or Preferred Term).
|
Additional Information
Eisai Inc.
Eisai Call Center
Phone: 888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER