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 Overview
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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.

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.

Official Title
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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

Conditions
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Lactating Women

Intervention / Treatment
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* Drug: Lusedra
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: arm 1<br> | Drug: Lusedra<br>* 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)<br>|
| Active Comparator: arm 2<br> | Drug: Propofol<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Monitored anesthesia care