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Completed

NCT Number: NCT06580587

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

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.

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Key information

Conditions

Healthy HIV Pre-Exposure Prophylaxis

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0002), Springfield, Missouri, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-8527

Drug

Oral administration

Primary outcomes

  1. 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

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

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

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

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

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

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

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

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

Secondary outcomes

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

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

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

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

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

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

  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 Blood

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

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

  4. 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

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

    Blood samples will be collected to determine AUC0-inf after administration of a single oral dose of MK-8527.

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

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

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

  6. Time to Maximum Blood Concentration (Tmax) After Administration of a Single Oral Dose of MK-8527

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

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

  7. 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

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

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

  8. 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

    Time frame: Predose and at designated timepoints up to 7 days postdose

    Plasma samples will be collected to determine AUC0-inf.

  9. Maximum Plasma Concentration (Cmax) After Administration of a Single Oral Dose of MK-8527

    Time frame: Predose and at designated timepoints up to 7 days postdose

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

  10. Time to Maximum Plasma Concentration (Tmax) After Administration of a Single Oral Dose of MK-8527

    Time frame: Predose and at designated timepoints up to 7 days postdose

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

  11. Ratio of MK-8527 in Breast Milk to Blood After Administration of a Single Dose of MK-8527

    Time frame: At designated timepoints up to 120 hours postdose

    Ratio of MK-8527 in breast milk to blood will be used to estimate dose of MK-8527.

  12. Ratio of MK-8527 in Breast Milk to Plasma After Administration of a Single Oral Dose

    Time frame: At designated timepoints up to 120 hours postdose

    Ratio of MK-8527 in breast milk to plasma will be used to estimate dose of MK-8527.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 30, 2024
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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