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

Eisai

Status and phase

Completed

Phase 1

Conditions

Lactating Women

Treatments

Drug: Propofol

Drug: Lusedra

Study type

Interventional

Funder types

Industry

Identifiers

NCT01309984

E2083-A001-405

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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).