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
- 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.
- Presence or history of any disorder that may prevent the successful completion of the
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal,
endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric