Clinical trial NCT06580587: A Study of MK-8527 in Healthy Lactating Female Participants (MK-8527-009)
Official title: A Clinical Study to Evaluate the Breast Milk, Plasma and Whole Blood Pharmacokinetics of MK-8527 in Healthy Lactating Female Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
HIV Pre-exposure Prophylaxis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-08-30
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Predose and at designated timepoints up to 120 hours postdose
measure: Maximum Breast Milk Concentration (Cmax) After Administration of a Single Oral Dose of MK-8527
timeFrame: Predose and at designated timepoints up to 21 days postdose
measure: Time to Maximum Breast Milk Concentration (Tmax) After Administration of a Single Oral Dose of MK-8527
timeFrame: Predose and at designated timepoints up to 21 days postdose
Secondary outcomes:
measure: Mean Concentration of MK-8527 in Breast Milk After Administration of a Single Oral Dose
timeFrame: Predose and at designated timepoints up to 120 hours postdose
measure: Amount Excreted in Breast Milk From Time Zero to 120 Hours (Ae0-120hrs) After Administration of a Single Oral Dose of MK-8527
timeFrame: Predose and at designated timepoints up to 120 hours postdose
measure: 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
timeFrame: Predose and at designated timepoints up to 120 hours postdose
measure: 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
timeFrame: Predose and at designated timepoints up to 21 days postdose
measure: Maximum Blood Concentration (Cmax) After Administration of a Single Oral Dose of MK-8527
timeFrame: Predose and at designated timepoints up to 21 days postdose
measure: Time to Maximum Blood Concentration (Tmax) After Administration of a Single Oral Dose of MK-8527
timeFrame: Predose and at designated timepoints up to 21 days postdose
measure: 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
timeFrame: Predose and at designated timepoints up to 120 hours postdose
measure: 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
timeFrame: Predose and at designated timepoints up to 7 days postdose
measure: Maximum Plasma Concentration (Cmax) After Administration of a Single Oral Dose of MK-8527
timeFrame: Predose and at designated timepoints up to 7 days postdose
measure: Time to Maximum Plasma Concentration (Tmax) After Administration of a Single Oral Dose of MK-8527
timeFrame: Predose and at designated timepoints up to 7 days postdose
measure: Ratio of MK-8527 in Breast Milk to Blood After Administration of a Single Dose of MK-8527
timeFrame: At designated timepoints up to 120 hours postdose
measure: Ratio of MK-8527 in Breast Milk to Plasma After Administration of a Single Oral Dose
timeFrame: At designated timepoints up to 120 hours postdose
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Magee-Womens Hospital
state: Pennsylvania
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: