A Study of MK-8527 in Healthy Lactating Female Participants (MK-8527-009)
NCT ID: NCT06580587
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
12 participants
INTERVENTIONAL
2025-04-15
2026-02-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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MK-8527
Participants receive single oral dose of MK-8527 on Day 1
MK-8527
Oral administration
Interventions
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MK-8527
Oral administration
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0001)
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
Role: primary
Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-8527-009
Identifier Type: OTHER
Identifier Source: secondary_id
8527-009
Identifier Type: -
Identifier Source: org_study_id