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

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

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 Overview

• Status: Completed
• Conditions: Healthy; HIV Pre-exposure Prophylaxis
• Intervention / Treatment: Drug: MK-8527

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Springfield, Missouri, United States, 65802
      • Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0002)
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0001)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MK-8527; Participants receive single oral dose of MK-8527 on Day 1	Drug: MK-8527; Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Predose and at designated timepoints up to 21 days postdose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	Blood samples will be collected to determine AUC0-120hrs after administration of a single oral dose of MK-8527.	Predose and at designated timepoints up to 120 hours postdose
Area Under the Concentration-Time Curve from Time 0 to Time-Infinity (AUC0-Inf) After Administration of a Single Oral Dose of MK-8527 in Blood	Blood samples will be collected to determine AUC0-inf after administration of a single oral dose of MK-8527.	Predose and at designated timepoints up to 21 days postdose
Maximum Blood Concentration (Cmax) After Administration of a Single Oral Dose of MK-8527	Blood samples will be collected to determine the Cmax after administration of a single oral dose of MK-8527.	Predose and at designated timepoints up to 21 days postdose
Time to Maximum Blood Concentration (Tmax) After Administration of a Single Oral Dose of MK-8527	Blood samples will be collected to determine the Tmax after administration of a single oral dose of MK-8527.	Predose and at designated timepoints up to 21 days postdose
Area Under the Concentration-Time Curve from Time 0 to 120hours (AUC0-120hrs) After Administration of a Single Oral Dose of MK-8527 in Plasma	Plasma samples will be collected to determine AUC0-120hrs after administration of a single oral dose of MK-8527.	Predose and at designated timepoints up to 120 hours postdose
Area Under the Concentration-Time Curve from Time 0 to Time-Infinity (AUC0-Inf) After Administration of a Single Oral Dose of MK-8527 in Plasma	Plasma samples will be collected to determine AUC0-inf.	Predose and at designated timepoints up to 7 days postdose
Maximum Plasma Concentration (Cmax) After Administration of a Single Oral Dose of MK-8527	Plasma samples will be collected to determine the Cmax after administration of a single oral dose of MK-8527.	Predose and at designated timepoints up to 7 days postdose
Time to Maximum Plasma Concentration (Tmax) After Administration of a Single Oral Dose of MK-8527	Plasma samples will be collected to determine the Tmax after administration of a single oral dose of MK-8527.	Predose and at designated timepoints up to 7 days postdose
Ratio of MK-8527 in Breast Milk to Blood After Administration of a Single Dose of MK-8527	Ratio of MK-8527 in breast milk to blood will be used to estimate dose of MK-8527.	At designated timepoints up to 120 hours postdose
Ratio of MK-8527 in Breast Milk to Plasma After Administration of a Single Oral Dose	Ratio of MK-8527 in breast milk to plasma will be used to estimate dose of MK-8527.	At designated timepoints up to 120 hours postdose

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Actual): March 27, 2026
• Study Completion (Actual): March 27, 2026

Study Registration Dates

• First Submitted: August 28, 2024
• First Submitted That Met QC Criteria: August 28, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 8527-009; MK-8527-009 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No