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

NCT00751764 | Completed Phase 1

• 1 other identifier: 3110A1-1002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection

Outcome Measures

Primary Outcomes (1)

• Blood samples

  4 months

Secondary Outcomes (1)

• Safety based on adverse event monitoring, vital sign measurements, 12-lead ECGs and routine lab tests.

  4 months

Study Arms (1)

1

EXPERIMENTAL

Drug: Moxidectin

Interventions

Moxidectin DRUG

1

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (1)

Unknown Facility

Plymouth, PL6 5HH, United Kingdom

Location

MeSH Terms

Conditions

Infections

Interventions

moxidectin

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 11, 2008
• First Posted: September 12, 2008
• Study Start: November 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: September 16, 2010

Record last verified: 2010-09

Locations

GB (1)