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
- Registration Number
- NCT01309984
- Lead Sponsor
- Eisai Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description arm 1 Lusedra - arm 2 Propofol -
- Primary Outcome Measures
Name Time Method The fraction (%) of the maternal dose transferred to breast milk in 24 hours 24 hours 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
NorthShore University HealthSystem
🇺🇸Evanston, Illinois, United States