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

Merck Sharp & Dohme LLC13 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy HIV Pre-exposure Prophylaxis

Interventions

MK-8527DRUG

Oral administration

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0002)

Springfield, Missouri, United States

University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0001)

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Area Under the Concentration-Time Curve from Time 0 to 120 hours (AUC0-120hrs) After Administration of a Single Oral Dose of MK-8527 in Breast Milk

Breast milk samples will be collected to determine the AUC0-120hrs after administration of a single oral dose of MK-8527.

Time frame: Predose and at designated timepoints up to 120 hours postdose

Maximum Breast Milk Concentration (Cmax) After Administration of a Single Oral Dose of MK-8527

Breast milk samples will be collected to determine the Cmax after administration of a single oral dose of MK-8527.

Time frame: Predose and at designated timepoints up to 21 days postdose

Time to Maximum Breast Milk Concentration (Tmax) After Administration of a Single Oral Dose of MK-8527

Breast milk samples will be collected to determine the Tmax after administration of a single oral dose of MK-8527.

Time frame: Predose and at designated timepoints up to 21 days postdose

Secondary Outcomes

Mean Concentration of MK-8527 in Breast Milk After Administration of a Single Oral Dose

Breast milk samples will be collected to determine the mean concentration of MK-8527.

Time frame: Predose and at designated timepoints up to 120 hours postdose

Amount Excreted in Breast Milk From Time Zero to 120 Hours (Ae0-120hrs) After Administration of a Single Oral Dose of MK-8527

Breast milk samples will be collected to determine the Ae0-120hrs after administration of a single oral dose of MK-8527.

Time frame: Predose and at designated timepoints up to 120 hours postdose

Area Under the Concentration-Time Curve from Time 0 to 120 hours (AUC0-120hrs) After Administration of a Single Oral Dose of MK-8527 in Blood

Data from ClinicalTrials.gov

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