- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01309984
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
November 2, 2015 updated by: Eisai Inc.
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
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
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Evanston, Illinois, United States, 60201
- NorthShore University HealthSystem
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 43 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: arm 1
|
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
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total amount (Ae0-24) of propofol transferred to breast milk in 24 hours.
Time Frame: 24 hours
|
24 hours
|
Total amount (Ae0-24) of fospropofol transferred to breast milk in 24 hours
Time Frame: 24 hours
|
24 hours
|
The fraction (%) of the maternal dose transferred to breast milk in 24 hours
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Christa Nagy, Eisai Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
March 2, 2011
First Submitted That Met QC Criteria
March 4, 2011
First Posted (Estimate)
March 7, 2011
Study Record Updates
Last Update Posted (Estimate)
November 3, 2015
Last Update Submitted That Met QC Criteria
November 2, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E2083-A001-405
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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