A Clinical Study to Evaluate the Breast Milk, Plasma and Whole Blood Pharmacokinetics of MK-8527 in Healthy Lactating Female Participants

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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 time points.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
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⁃ 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

Locations
United States
Pennsylvania
University of Pittsburgh Medical Center Magee-Womens Hospital
RECRUITING
Pittsburgh
Time Frame
Start Date: 2025-04-15
Estimated Completion Date: 2025-12-19
Participants
Target number of participants: 12
Treatments
Experimental: MK-8527
Participants receive single oral dose of MK-8527 on Day 1
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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