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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01309984
First received: March 2, 2011
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Lactating Women
Drug: Lusedra
Drug: Propofol
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Total amount (Ae0-24) of propofol transferred to breast milk in 24 hours. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Total amount (Ae0-24) of fospropofol transferred to breast milk in 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • The fraction (%) of the maternal dose transferred to breast milk in 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: November 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: arm 1 Drug: 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)
Active Comparator: arm 2 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)

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01309984

Locations
United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Christa Nagy Eisai Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01309984     History of Changes
Other Study ID Numbers: E2083-A001-405
Study First Received: March 2, 2011
Last Updated: January 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Monitored anesthesia care

Additional relevant MeSH terms:
Propofol
Fospropofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on August 21, 2014