Completed

NCT Number: NCT01309984

A Study to Assess the Transfer of Fospropofol and Its Active Metabolite, Propofol, to Breast Milk Following Administration of LUSEDRA to Lactating Women Undergoing a Needed Procedure

The purpose of this study is to assess the transfer of fospropofol and its active metabolite, propofol, to breast milk following administration of LUSEDRA® to lactating women undergoing a needed procedure.

Completed

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Key information

Conditions

Lactating Women

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

About this study

E2083, or LUSEDRA® (fospropofol disodium) Injection, is an intravenous (IV) sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.1 It is a water-soluble, phosphono-O-methyl prodrug of propofol. Upon IV injection, the inactive fospropofol undergoes metabolism, most notably by alkaline phosphatase enzymes, to yield the active metabolite (propofol), phosphate, and formaldehyde. Formaldehyde is quickly converted to formate in vivo, and formate is further metabolized by a folate-dependent mechanism.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusions:

Lactating women undergoing a needed procedure expected to last between approximately 10 to 45 minutes
Subjects should be between 6 weeks and 8 months postpartum
Lactation must be well-established in subjects
Subject's infants must be full term and able to bottle-feed
Infants should be predominantly breast milk fed and should not receive more than one bottle of formula per day

Exclusions:

Subjects who are pregnant
Subjects undergoing a breast procedure (eg, biopsy, abscess drainage, etc.)
Subjects who are not willing to temporarily refrain from nursing their children during the 0-24 hour breast milk collection interval.

(Subjects may resume nursing following this interval).

Treatment and study plan

Lusedra

Drug

Pretreatment Phase - approximately 3 hours (Baseline) • Treatment Phase - approximately 8 days (includes Treatment, Discharge [up to 24 hours], and Follow-up Telephone Call on Day 8 post-dose after Discharge)

Propofol

Drug

Primary outcomes

Total amount (Ae0-24) of propofol transferred to breast milk in 24 hours.

Time frame: 24 hours
Total amount (Ae0-24) of fospropofol transferred to breast milk in 24 hours

Time frame: 24 hours
The fraction (%) of the maternal dose transferred to breast milk in 24 hours

Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study title

An Open-label, Single Initial-dose, Multi-center Study to Assess the Transfer of Fospropofol and Its Active Metabolite, Propofol, to Breast Milk Following Administration of LUSEDRA to Lactating Women Undergoing a Needed Procedure

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Mar 7, 2011
Registry last updated: Nov 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.