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

CompletedPhase 1

Sponsor: Merck Sharp & Dohme LLC

Conditions: Healthy, HIV Pre-exposure Prophylaxis

Interventions: MK-8527

Countries: United States

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 overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

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 Criteria:

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

Locations (2)

Springfield, Missouri, United States
Pittsburgh, Pennsylvania, United States