Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK-8527-009 | Other Identifier | MSD |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-8527 | Experimental | Participants receive single oral dose of MK-8527 on Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-8527 | Drug | Oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following
Healthy Lactating Female Participants
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0002) | Springfield | Missouri | 65802 | United States | ||
Not provided
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0001) |
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |