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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Inc.
• Treatments: Fospropofol; Propofol

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).