Study Evaluating The Excretion Of Moxidectin Into The Breast Milk Of Lactating, Non-Breastfeeding Women
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|ClinicalTrials.gov Identifier: NCT00751764|
Recruitment Status : Completed
First Posted : September 12, 2008
Last Update Posted : September 16, 2010
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|Condition or disease||Intervention/treatment||Phase|
|Infection||Drug: Moxidectin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Single-Dose Study to Evaluate the Excretion of Moxidectin Into the Breast Milk of Lactating, Non-breastfeeding Women.|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
- Blood samples [ Time Frame: 4 months ]
- Safety based on adverse event monitoring, vital sign measurements, 12-lead ECGs and routine lab tests. [ Time Frame: 4 months ]
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|Ages Eligible for Study:||21 Years to 45 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00751764
|Plymouth, United Kingdom, PL6 5HH|
|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|
|Responsible Party:||Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth|
|Other Study ID Numbers:||
|First Posted:||September 12, 2008 Key Record Dates|
|Last Update Posted:||September 16, 2010|
|Last Verified:||September 2010|