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

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01260142
• Other study ID #: E2083-A001-410
• Status: Completed
• Phase: Phase 4
• First received: December 13, 2010
• Last updated: July 10, 2014
• Start date: November 2010
• Est. completion date: March 2011

Study information

• Verified date: July 2014
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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		Total duration 28 days	No