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A PK/PD Study of Fospropofol Disodium Compared With Propofol Injectable Emulsion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01260142
First received: December 13, 2010
Last updated: November 30, 2016
Last verified: November 2016
Results First Received: November 30, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Anesthesia
Intervention: Drug: Fospropofol disodium, propofol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow for 2 periods

Period 1:   Treatment Period 1
    Cohort 1 (Sequence A)   Cohort 1 (Sequence B)   Cohort 2 (Sequence C)   Cohort 2 (Sequence D)   Cohort 3 (Sequence E)   Cohort 3 (Sequence F)
STARTED   6   6   6   6   6   6 
COMPLETED   5   5   6   6   4   3 
NOT COMPLETED   1   1   0   0   2   3 
Study on hold                1                1                0                0                1                2 
Unexplained elevated sys. BP                0                0                0                0                1                0 
Withdrawal by Subject                0                0                0                0                0                1 

Period 2:   Treatment Period 2
    Cohort 1 (Sequence A)   Cohort 1 (Sequence B)   Cohort 2 (Sequence C)   Cohort 2 (Sequence D)   Cohort 3 (Sequence E)   Cohort 3 (Sequence F)
STARTED   5   5   6   6   4   3 
COMPLETED   5   5   6   6   4   3 
NOT COMPLETED   0   0   0   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cohort 1 (Sequence A) 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) 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 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 Total of all reporting groups

Baseline Measures
   Cohort 1 (Sequence A)   Cohort 1 (Sequence B)   Cohort 2 (Sequence C)   Cohort 2 (Sequence D)   Cohort 3 (Sequence E)   Cohort 3 ( Sequence F)   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   6   6   6   6   6   36 
Age 
[Units: Years]
Mean (Standard Deviation)
 22.3  (1.51)   25.5  (3.78)   25.3  (4.46)   22.7  (2.88)   29  (4.34)   23.8  (3.37)   24.8  (3.98) 
Gender 
[Units: Participants]
Count of Participants
             
Female      2  33.3%      2  33.3%      3  50.0%      2  33.3%      2  33.3%      4  66.7%      15  41.7% 
Male      4  66.7%      4  66.7%      3  50.0%      4  66.7%      4  66.7%      2  33.3%      21  58.3% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of Fospropofol (AUC(0-inf))   [ Time Frame: 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). ]

2.  Primary:   Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of Propofol   [ Time Frame: 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). ]

3.  Primary:   Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC(0-t)) of Fospropofol   [ Time Frame: 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). ]

4.  Primary:   Area Under the Plasma Concentration-Time Curve From Time 0 to Time t of Propofol   [ Time Frame: 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). ]

5.  Primary:   Maximum Drug Plasma Concentration (Cmax) of Fospropofol   [ Time Frame: 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). ]

6.  Primary:   Maximum Drug Plasma Concentration of Propofol   [ Time Frame: 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). ]

7.  Secondary:   Maximal Sedative Effect Using the Bispectral Index (BIS) Score   [ Time Frame: 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) ]

8.  Secondary:   Maximal Sedative Effect Using the Modified Observer's Assessment of Alertness/Sedation Scale   [ Time Frame: 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). ]

9.  Secondary:   Relative Bioavailability of Fospropofol and Propofol   [ Time Frame: 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). ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Eisai Inc.
Organization: Eisai Call Center
phone: 888-422-4743



Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01260142     History of Changes
Other Study ID Numbers: E2083-A001-410
Study First Received: December 13, 2010
Results First Received: November 30, 2016
Last Updated: November 30, 2016