Status:
COMPLETED
Study Evaluating The Excretion Of Moxidectin Into The Breast Milk Of Lactating, Non-Breastfeeding Women
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Infection
Eligibility:
FEMALE
21-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the extent of moxidectin transfer into the breast milk of lactating women and to provide the initial pharmacokinetic and safety profile of moxidectin in lactat...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy lactating women aged 21 to 45 years inclusive at screening. Women should:
- Be at least 12-weeks postpartum after uncomplicated delivery with a full milk supply established.
- Be willing to discontinue breastfeeding permanently and should be in the process of weaning their infant. Care should be taken to ensure that subjects have not discontinued breastfeeding an infant in order to participate in the study.
- Not plan to breastfeed within 9 months of study drug administration.
- Be willing to fully express breast milk from both breasts during the duration of the milk collection portion of the study. Subjects must be able to express milk from each breast at each pumping session using a breast pump.
- Body mass index in the range of 18 to 35 kg/m2.
- Exclusion criteria:
- Presence or history of any disorder that may prevent the successful completion of the study.
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00751764
Start Date
November 1 2008
End Date
September 1 2009
Last Update
September 16 2010
Active Locations (1)
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1
Plymouth, United Kingdom, PL6 5HH