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

NCT00751764

Last updated date
Study Location
Plymouth, , PL6 5HH, United Kingdom
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Infection
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-45 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating The Excretion Of Moxidectin Into The Breast Milk Of Lactating, Non-Breastfeeding Women
Official Title  ICMJE An Open-Label, Single-Dose Study to Evaluate the Excretion of Moxidectin Into the Breast Milk of Lactating, Non-breastfeeding Women.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Infection
Intervention  ICMJE Drug: Moxidectin
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Moxidectin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 11, 2008)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 21 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00751764
Other Study ID Numbers  ICMJE 3110A1-1002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP