A Study of MK-8527 in Healthy Lactating Female Participants (MK-8527-009)
NCT Number: NCT06580587
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy|HIV Pre-exposure Prophylaxis
Interventions: DRUG: MK-8527
Sponsor: Merck Sharp & Dohme LLC
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-10-23
Completion Date: 2025-12-19

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.

Primary Outcome Measures: 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: 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