Healthy, HIV Pre-exposure Prophylaxis
Conditions
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.
Interventions
DRUGMK-8527
Oral administration
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed