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Study Evaluating The Excretion Of Moxidectin Into The Breast Milk Of Lactating, Non-Breastfeeding Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00751764
Recruitment Status : Completed
First Posted : September 12, 2008
Last Update Posted : September 16, 2010
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Study Description
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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 lactating women.

Condition or disease Intervention/treatment Phase
Infection Drug: Moxidectin Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine

Drug Information available for: Moxidectin

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: Moxidectin


Outcome Measures
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Primary Outcome Measures :
  1. Blood samples [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Safety based on adverse event monitoring, vital sign measurements, 12-lead ECGs and routine lab tests. [ Time Frame: 4 months ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United Kingdom
Plymouth, United Kingdom, PL6 5HH
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
More Information
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Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00751764    
Other Study ID Numbers: 3110A1-1002
First Posted: September 12, 2008    Key Record Dates
Last Update Posted: September 16, 2010
Last Verified: September 2010
Additional relevant MeSH terms:
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Moxidectin
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Antinematodal Agents