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

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00751764
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 10
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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

• Study Type: Interventional
• Anticipated 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: Nov 1, 2008
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Moxidectin

Outcome Measures

Primary Outcome Measures

1. Blood samples [4 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1		Plymouth		United Kingdom	PL6 5HH

Sponsors and Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

• Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00751764
• Other Study ID Numbers: 3110A1-1002
• First Posted: Sep 12, 2008
• Last Update Posted: Sep 16, 2010
• Last Verified: Sep 1, 2010

• Additional relevant MeSH terms: Moxidectin

Study Results

No Results Posted as of Sep 16, 2010