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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01309984

Enrollment

Registered

2011-03-07

Start date

2010-11-30

Completion date

2012-10-31

Last updated

2015-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lactating Women

Keywords

Monitored anesthesia care

Brief summary

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.

Detailed description

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.

Interventions

DRUGLusedra

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)

DRUGPropofol

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

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).

Design outcomes

Primary

Measure	Time frame
Total amount (Ae0-24) of propofol transferred to breast milk in 24 hours.	24 hours
Total amount (Ae0-24) of fospropofol transferred to breast milk in 24 hours	24 hours
The fraction (%) of the maternal dose transferred to breast milk in 24 hours	24 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026