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

NCT ID: NCT00751764

Last Updated: 2010-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-09-30

Brief Summary

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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

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Conditions

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Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Moxidectin

Intervention Type DRUG

Interventions

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Moxidectin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Wyeth

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Plymouth, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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3110A1-1002

Identifier Type: -

Identifier Source: org_study_id