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

NCT06580587 | Completed Phase 1 FDA Drug

• 2 other identifiers: 8527-009MK-8527-009
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

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

  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

  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

  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

  Predose and at designated timepoints up to 21 days postdose

• Maximum Blood Concentration (Cmax) After Administration of a Single Oral Dose of MK-8527

  Predose and at designated timepoints up to 21 days postdose

Study Arms (1)

MK-8527

EXPERIMENTAL

Participants receive single oral dose of MK-8527 on Day 1

Drug: MK-8527

Interventions

MK-8527 DRUG

Oral administration

MK-8527

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Healthy Lactating Female Participants
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (2)

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

Springfield, Missouri, 65802, United States

Location

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

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Links

• Merck Clinical Trials Information

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: August 30, 2024
• Study Start: April 15, 2025
• Primary Completion: March 27, 2026
• Study Completion: March 27, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (2)