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

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01260142
First received: December 13, 2010
Last updated: May 16, 2011
Last verified: May 2011
  Purpose

This study is designed to characterize the pharmacokinetic and pharmacodynamic effect of fospropofol disodium in comparison to propofol. In addition, the study will compare the maximum sedative effect, safety and tolerability of fospropofol disodium and propofol.


Condition Intervention Phase
Anesthesia
Drug: Fospropofol disodium, propofol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Single-Bolus, 2-Period, Multi-Dose Level, 3 Cohort Crossover Design, Pharmacokinetic/Pharmacodynamic Study of Lusedra (Fospropofol Disodium) Injection Compared With Propofol Injectable Emulsion

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • • The primary objective of the study is to characterize the PK and PD properties of 3 dose levels of fospropofol disodium in comparison with 3 estimated equivalent dose levels of propofol [ Time Frame: Total duration 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: November 2010
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Fospropofol disodium, propofol
Two Treatment Periods: fospropofol disodium 6.5 mg/kg single intravenous (IV) bolus followed by propofol injectable emulsion 0.65 mg/kg IV bolus, or propofol injectable emulsion 0.65 mg/kg IV bolus followed by fospropofol disodium 6.5 mg/kg IV bolus.
Experimental: Arm 2 Drug: Fospropofol disodium, propofol
Two Treatment Periods: fospropofol disodium 10.0 mg/kg single intravenous (IV) bolus followed by propofol injectable emulsion 1.0 mg/kg IV bolus, or propofol injectable emulsion 1.0 mg/kg IV bolus followed by fospropofol disodium 10.0 mg/kg IV bolus.
Experimental: Arm 3 Drug: Fospropofol disodium, propofol
Two Treatment Periods: fospropofol disodium 15.0 mg/kg single intravenous (IV) bolus followed by propofol injectable emulsion 1.5 mg/kg IV bolus, or propofol injectable emulsion 1.5 mg/kg IV bolus followed by fospropofol disodium 15.0 mg/kg IV bolus.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion

  • Males or females >/= 18 to </= 45 years old
  • Non-smokers for at least 18 months prior to Screening
  • Body Mass Index (BMI) </= 30

Exclusion

  • Subjects having a past or current medical history of any respiratory illness including asthma
  • Subjects currently taking any medications (birth control will be allowed if the subject has been taking it for at least 12 weeks prior to dosing and during the entire study), including over-the-counter (OTC) medication, within 14 days of screening
  • Subjects with a known or suspected history of drug or alcohol misuse within 6 months prior to Screening, or who have a positive urine drug test at Screening and pre-dose at Visit 2 and Visit 3
  • Subjects who are allergic to eggs, egg products, soybeans, or soy products
  • Subjects with a positive pregnancy test at Screening or breastfeeding
  • Subjects who are unwilling or unable to abide by the requirements of the study
  • Subjects who have any condition that would make him/her, in the opinion of the investigator, unsuitable for the study or who, in the opinion of the investigator, are not likely to complete the study for any reason
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01260142

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Randi Fain Eisai Inc.
  More Information

No publications provided

Responsible Party: Elma Manikan, Eisai Inc
ClinicalTrials.gov Identifier: NCT01260142     History of Changes
Other Study ID Numbers: E2083-A001-410
Study First Received: December 13, 2010
Last Updated: May 16, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Propofol
Fospropofol disodium
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on April 21, 2014