A Study of MK-8527 in Healthy Lactating Female Participants (MK-8527-009)

Korábbi kezelés

• Had mastitis within 30 days prior to administration of study drug
• Has a positive pregnancy test at the time of screening or prior to treatment allocation

Más betegség

• Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, psychiatric, or major neurological (including stroke and chronic seizures) abnormalities or diseases

Egyéb

• The key exclusion criteria include but are not limited to the following

• The key inclusion criteria include but are not limited to the following:
• Is at least 6 weeks postpartum at the time of administration of study intervention, following the delivery of a healthy singleton neonate
• Is willing and able to express breast milk at least twice daily for at least 120 hours after enrollment
• Is willing to discontinue breastfeeding from the time of administration of study intervention until at least 6 weeks following the administration of study intervention. This includes the avoidance of both directly breastfeeding and the administration of breast milk pumped during the above-specified time frame to the infant. Is willing to confirm with the site that the infant is able to bottle feed (breast milk) prior to Day 1 and that alternative nutrition (i.e., previously stored breast milk or infant formula) is available for feeding the infant through the 6-week post dose period