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

Launched by MERCK SHARP & DOHME LLC · Aug 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called MK-8527 to understand how it moves through the body of healthy breastfeeding women and how much of it gets into their breast milk. The researchers want to see what happens over time after the medication is given, specifically looking at how it might affect a baby who is breastfeeding.

To participate, women need to be at least six weeks postpartum (after giving birth) and willing to stop breastfeeding for six weeks after receiving the medication. They should be able to express breast milk at least twice a day during the study period and have alternative feeding options, like previously stored breast milk or formula, for their baby. The study is currently recruiting women aged 6574 and is focused on ensuring that participants have no significant health issues that could interfere with the study. Participants can expect to provide breast milk samples and will be monitored closely throughout the trial.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• 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
• Exclusion Criteria:
• • The key exclusion criteria include but are not limited to the following
• • 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
• • 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