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

Completed · Phase 1

Conditions studied: Healthy, HIV Pre-exposure Prophylaxis

In brief

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 time points.

Key facts

Study ID

NCT06580587

Run by

Merck Sharp & Dohme LLC

People needed

13

Starts

2025-04-15

Expected to finish

2026-03-27

Last updated by the study team

2026-04-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0002) — Springfield, Missouri, United States
• University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0001) — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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