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

Description

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.

Conditions

Healthy, HIV Pre-exposure Prophylaxis

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Healthy
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

University of Pittsburgh Medical Center Magee-Womens Hospital, Pittsburgh, Pennsylvania, United States, 15213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2025-12-19