Infection
Conditions
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.
Interventions
DRUGMoxidectin
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 45 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood samples | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Safety based on adverse event monitoring, vital sign measurements, 12-lead ECGs and routine lab tests. | 4 months |
Countries
United Kingdom
Outcome results
None listed