A Study of Prucalopride in Breastfeeding Women With Constipation

Inclusion Criteria:

Participants cannot be enrolled before all inclusion criteria are confirmed.

• Female participants with an ability to voluntarily provide verbal followed bywritten, signed, and dated (personally or via a legally authorized representative)informed consent as applicable to participate in the study.

• Participants greater than or equal to (>=) 18 years of age at the time of consent.This inclusion criterion will only be assessed at the time of enrollment.

• Participants who are currently breastfeeding a singleton infant who is between 10days and 11 months 0 days. Note that participants pumping breast milk and bottlefeeding their infant breast milk are allowed to participate.

• Participants who are currently exclusively breastfeeding or breastfeeding withsupplemental formula and/or solid food. Infants who are exclusively breastfed and donot eat solid food are preferred.

• Participants who are currently treated as prescribed by their physician withMOTEGRITY or RESOTRAN (generic forms of prucalopride not allowed) for functionalconstipation, including chronic idiopathic constipation (CIC) and irritable bowelsyndrome-constipation (IBS-C), for at least 5 consecutive days at the time of takingthe first breastmilk sample.

• Participants who agree to the conditions and requirements of the study including thesample collection, interview schedule, completion of developmental questionnaires,and release of medical records.

• Participants with an understanding, ability, and willingness to fully comply withstudy procedures and restrictions.

Exclusion Criteria:

The participant will be excluded from the study if any of the following exclusion criteria are met:

• Participants who are breastfeeding an infant who: is hospitalized, has a major birthdefect, or has a history of a disease that could affect absorption or drugdisposition.

• Participants who have used MOTEGRITY or RESOTRAN while breastfeeding for a conditionother than functional constipation.

• Participants who are pregnant at the time of enrollment.

• Participants who have started to wean their child from breast milk.

• Participants with a history of any hematological, hepatic, respiratory,cardiovascular, renal, gall bladder removal, or other current or recurrent diseasethat could affect the action, absorption, or disposition of prucalopride.