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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxidectin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood samples | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety based on adverse event monitoring, vital sign measurements, 12-lead ECGs and routine lab tests. | 4 months |
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Inclusion criteria:
Healthy lactating women aged 21 to 45 years inclusive at screening. Women should:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Plymouth | PL6 5HH | United Kingdom |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| C027837 | moxidectin |
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