An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating Females

This study is looking at how a medicine called tenapanor and another compound called AZ13792925 behave in the breast milk of moms who are breastfeeding. The study will help us understand how much of these substances pass into breast milk. Moms who participate will take tenapanor for 4 days and their breast milk will be collected and tested at different times on Day 4. After the last dose, the study team will monitor the moms for 24 hours.

Those participating should not feed their babies the breast milk collected during the study to ensure it is not used by the baby. Moms will have a follow-up visit 5 to 7 days after stopping the medicine. Moms joining must be healthy, not pregnant, and already breastfeeding for at least 4 weeks. They should also agree not to give the collected milk to their babies while taking the medicine and for 3 days after the last dose.

• Study lasts about 10 days, including follow-up.
• Moms need to pump milk regularly during the study.
• Participants cannot take certain medicines or have certain health conditions.