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

Phase 1

Completed

• Conditions: Monitored Anesthesia Care
• Interventions: Drug: arm 1; Drug: LUSEDRA; Drug: Propofol (arm 3)

• Registration Number: NCT01308541
• Lead Sponsor: Eisai Inc.

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.

Detailed Description

The study is designed to explore the pharmacokinetics (PK) and the pharmacokinetic/ pharmacodynamic (PK/PD) relationship between PK-Bispectral Index (BIS) and PK-Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores following administration of LUSEDRA, administered as a bolus or by continuous infusion, with that of propofol injectable emulsion administered by continuous infusion, using compartmental modeling. The clinical practice of sedation spans an entire continuum of sedation, only a portion of which is currently addressed by the currently approved dose which is intended to provide a moderate level of sedation. Another goal of the current study is to support potential follow-up indications for fospropofol disodium, such as prolonged sedation in the Intensive Care Unit (ICU) and induction and maintenance of general anesthesia, which require higher doses. If successful, the data from this study would allow a direct comparison of propofol doses, delivered as fospropofol disodium or as propofol injectable emulsion, that provide the same sedation effect and directly compare concentration-effect relations of propofol liberated from fospropofol disodium with that delivered as propofol. The doses and infusion times for fospropofol disodium and propofol in this study were selected based on simulation results using an established PK/PD model developed from historical data. Data collected in the current study will be used to further refine the existing PK/PD model. To enhance the robustness of that model, the study design includes changes in dose over the duration of sedation in the three treatment groups.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-03-02
• Study First Submitted QC: 2011-03-03
• Study First Posted: 2011-03-04
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LUSEDRA (arm 1)	arm 1	-
LUSEDRA (arm 2)	LUSEDRA	-
Propofol (arm 3)	Propofol (arm 3)	-

Primary Outcome Measures

Name	Time	Method
Arterial plasma levels of fospropofol and propofol during each treatment:	up to 480 minutes postdose

Secondary Outcome Measures

Name	Time	Method
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
PD effect during each treatment measured by continuous BIS recordings	up to 480 minutes postdose

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City Utah, Utah, United States