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

Phase 1

Completed

• Conditions: Infection
• Interventions: Drug: Moxidectin

• Registration Number: NCT00751764
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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 available

Study Timeline

• Study First Submitted: 2008-09-11
• Study First Submitted QC: 2008-09-11
• Study First Posted: 2008-09-12
• Study Start: 2008-11
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-15
• Last Update Posted: 2010-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Moxidectin	-

Primary Outcome Measures

Name	Time	Method
Blood samples	4 months

Secondary Outcome Measures

Name	Time	Method
Safety based on adverse event monitoring, vital sign measurements, 12-lead ECGs and routine lab tests.	4 months