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

NCT01308541 | Completed Phase 1

• 1 other identifier: E2083-A001-006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Monitored Anesthesia Care

Outcome Measures

Primary Outcomes (1)

• Arterial plasma levels of fospropofol and propofol during each treatment:

  up to 480 minutes postdose

Secondary Outcomes (3)

• PD effect during each treatment measured by continuous BIS recordings

  up to 480 minutes postdose

• PD effect during each treatment measured by sedation (MOAA/S) assessments

  up to 480 minutes postdose

• Relationships between PK and PD of fospropofol and propofol will be explored using PK/PD modeling.

  up to 480 minutes postdose

Study Arms (3)

LUSEDRA (arm 1)

ACTIVE COMPARATOR

Drug: arm 1

LUSEDRA (arm 2)

ACTIVE COMPARATOR

Drug: LUSEDRA

Propofol (arm 3)

ACTIVE COMPARATOR

Drug: Propofol (arm 3)

Interventions

arm 1 DRUG

Bolus Dose: two bolus doses of 15.0 mg/kg (first dose) and 8.0 mg/kg (second dose), 40 minutes apart. Continuous Infusion Dose: Total dose of 42.0 mg/kg administered over 3 hours at an infusion rate of 0.40 mg/kg/min for 1 hour, followed by 0.20 mg/kg/min for 1 hour, followed by 0.10 mg/kg/min for 1 hour.

LUSEDRA (arm 1)

LUSEDRA DRUG

Mode of administration: intravenous (IV).Continuous Infusion Dose: Total dose of 42.0 mg/kg administered over 3 hours at an infusion rate of 0.40 mg/kg/min for 1 hour, followed by 0.20 mg/kg/min for 1 hour, followed by 0.10 mg/kg/min for 1 hour.

LUSEDRA (arm 2)

Propofol (arm 3) DRUG

Mode of administration: intravenous (IV). A loading dose administered at a constant infusion rate of 0.20 mg/kg/min (0.50 mL/kg/min) for 10 minutes, followed by a constant-rate 2-hour infusion at 0.10 mg/kg/min; total dose infused over 130 minutes is 14.0 mg/kg.

Propofol (arm 3)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Nonsmoking male and female subjects, age \>/= 18 to \</= 45 years old at Screening.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

University of Utah

Salt Lake City Utah, Utah, 84132Ut, United States

Location

MeSH Terms

Interventions

fospropofol; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Talmage Egan

  Eisai Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2011
• First Posted: March 4, 2011
• Study Start: January 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: November 3, 2015

Record last verified: 2015-11

Locations

US (1)