A Study of MK-8527 in Healthy Lactating Female Participants (MK-8527-009)
- Registration Number
- NCT06580587
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 12
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
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MK-8527 MK-8527 Participants receive single oral dose of MK-8527 on Day 1
- Primary Outcome Measures
Name Time Method 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 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.
Maximum Breast Milk Concentration (Cmax) After Administration of a Single Oral Dose of MK-8527 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.
Time to Maximum Breast Milk Concentration (Tmax) After Administration of a Single Oral Dose of MK-8527 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 Outcome Measures
Name Time Method 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 Breast milk samples will be collected to determine the mean concentration of MK-8527.
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 Breast milk samples will be collected to determine the Ae0-120hrs after administration of a single oral dose of MK-8527.
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 Blood samples will be collected to determine AUC0-120hrs after administration of a single oral dose of MK-8527.
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 Blood samples will be collected to determine AUC0-inf after administration of a single oral dose of MK-8527.
Maximum Blood Concentration (Cmax) After Administration of a Single Oral Dose of MK-8527 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.
Time to Maximum Blood Concentration (Tmax) After Administration of a Single Oral Dose of MK-8527 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.
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 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.
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 Predose and at designated timepoints up to 7 days postdose Plasma samples will be collected to determine AUC0-inf.
Maximum Plasma Concentration (Cmax) After Administration of a Single Oral Dose of MK-8527 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.
Time to Maximum Plasma Concentration (Tmax) After Administration of a Single Oral Dose of MK-8527 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.
Ratio of MK-8527 in Breast Milk to Blood After Administration of a Single Dose of MK-8527 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.
Ratio of MK-8527 in Breast Milk to Plasma After Administration of a Single Oral Dose 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.
Trial Locations
- Locations (1)
University of Pittsburgh Medical Center Magee-Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States