Status:
RECRUITING
A Study of MK-8527 in Healthy Lactating Female Participants (MK-8527-009)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Healthy
HIV Pre-exposure Prophylaxis
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
The goal of this study is to learn how MK-8527 moves through the healthy person's body over time. Researchers will measure for the amount of MK-8527 in breast milk that the baby will receive at many t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 19 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06580587
Start Date
April 15 2025
End Date
February 19 2026
Last Update
January 6 2026
Active Locations (1)
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1
University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0001)
Pittsburgh, Pennsylvania, United States, 15213