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

NCT01309984 | Completed Phase 1

• 1 other identifier: E2083-A001-405
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Lactating Women

Keywords

Monitored anesthesia care

Outcome Measures

Primary Outcomes (3)

• 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

• The fraction (%) of the maternal dose transferred to breast milk in 24 hours

  24 hours

Study Arms (2)

arm 1

ACTIVE COMPARATOR

Drug: Lusedra

arm 2

ACTIVE COMPARATOR

Drug: Propofol

Interventions

Lusedra DRUG

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)

arm 1

Propofol DRUG

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)

arm 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Interventions

fospropofol; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Christa Nagy

  Eisai Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2011
• First Posted: March 7, 2011
• Study Start: November 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 3, 2015

Record last verified: 2015-11

Locations

US (1)