NCT06580587CompletedPhase 1
A Study of MK-8527 in Healthy Lactating Female Participants (MK-8527-009)
A Clinical Study to Evaluate the Breast Milk, Plasma and Whole Blood Pharmacokinetics of MK-8527 in Healthy Lactating Female Participants
Source: ClinicalTrials.gov · Last updated 16 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 13 (actual)
- First submitted
- 28 Aug 2024
- Start date
- Apr 2025
- Primary completion date
- Mar 2026
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- HIV
- NCT number
- NCT06580587
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 13
- From Apr 2025 to the primary completion date, Mar 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- The key exclusion criteria include but are not limited to the following
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0001) Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0002) Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.