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

Merck Sharp & Dohme (MSD)

Status and phase

Enrolling

Phase 1

Conditions

Healthy

HIV Pre-exposure Prophylaxis

Treatments

Drug: MK-8527

Study type

Interventional

Funder types

Industry

Identifiers

NCT06580587

8527-009

MK-8527-009 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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