A Study to Characterize Pharmacokinetics (PK) and Pharmacodynamics (PD) of LUSEDRA® Administered as Continuous Infusion or Bolus Compared With Continuous Infusion of Propofol Injectable Emulsion

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to explore the pharmacokinetics (PK) and pharmacodynamics (PD) of LUSEDRA® administered as a continuous infusion or bolus compared with continuous infusion of propofol injectable emulsion.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eisai Inc.
• Treatments: Fospropofol; Propofol

Criteria

Inclusion:

• Nonsmoking male and female subjects, age >/= 18 to Exclusion:

• Body mass index (BMI) >/= 30

• Subjects who smoke or have used nicotine or nicotine-containing products within 18 months of Screening and throughout the study

• Subjects with a known history of clinically significant drug or food allergies, including allergies to any ingredients in either medication (fospropofol disodium or propofol injectable emulsion) or presently experiencing significant seasonal allergy

• Subjects who are allergic to eggs, egg products, soybeans, or soy products

• Subjects having a past or current medical history of any respiratory illness including asthma or sleep apnea

• Subjects with disorders of fat metabolism, or who are predisposed to fat embolism, or who have other conditions in which lipid emulsions must be used carefully

• Subjects currently taking any medications including over-the-counter (OTC) medication (within 14 days prior to Baseline Period 1) with the exceptions of hormonal contraceptives and hormone replacement therapy, as long as the subject was on a stable dose of the same product for at least 12 weeks prior to dosing.

• Use of 1.0% lidocaine <1.0 mL for placement of all arterial lines is allowed.