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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lactating Women

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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arm 1

Group Type ACTIVE_COMPARATOR

Lusedra

Intervention Type 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)

arm 2

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type 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)

Interventions

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Lusedra

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)

Intervention Type DRUG

Propofol

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)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No