Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK-8591A-061 | 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 what happens to doravirine (DOR) and islatravir (ISL) in a healthy lactating female's body over time. Researchers want to learn if DOR and ISL are in breast milk.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DOR/ISL | Experimental | Participants will receive DOR/ISL as an oral fixed-dose combination tablet once daily on Days 1 to 7. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DOR/ISL | Drug | Oral tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Amount of DOR Excreted in Breast Milk From 0 to 24 Hours (Ae0-24hrs) | Breast milk samples will be collected to determine the Ae0-24hrs after administration of DOR. | Predose and at designated timepoints up to 24 hours postdose |
| Body Weight Normalized Infant Theoretical Dose of DOR | Breast milk samples will be collected to calculate the theoretical daily (24 hour) infant dose of DOR as normalized by participant-reported infant body weight. | Predose and at designated timepoints up to 24 hours postdose |
| Relative Infant Theoretical Dose of DOR | Breast milk samples will be collected to calculate the theoretical daily (24 hour) infant dose of DOR relative to the maternal dose. | Predose and at designated timepoints up to 24 hours postdose |
| Cumulative Amount of Total ISL Excreted in Breast Milk From 0 to 24 Hours (Ae0-24hrs) | Breast milk samples will be collected to determine the Ae0-24hrs after administration of total ISL. | Predose and at designated timepoints up to 24 hours postdose |
| Body Weight Normalized Infant Theoretical Dose of ISL | Breast milk samples will be collected to calculate the theoretical daily (24 hour) infant dose of ISL as normalized by participant-reported infant body weight. | Predose and at designated timepoints up to 24 hours postdose |
| Relative Infant Theoretical Dose of ISL | Breast milk samples will be collected to calculate the theoretical daily (24 hour) infant dose of ISL relative to the maternal dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve From 0 to 24 Hours (AUC0-24hrs) of DOR in Breast Milk | Breast milk samples will be collected to determine the AUC0-24hrs of DOR. | Predose and at designated timepoints up to 24 hours postdose |
| Maximum Concentration (Cmax) of DOR in Breast Milk |
Not provided
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main 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 |
|---|---|---|---|---|---|---|
| QPS Missouri ( Site 0001) | 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
| Predose and at designated timepoints up to 24 hours postdose |
Breast milk samples will be collected to determine the Cmax of DOR. |
| Predose and at designated timepoints up to 24 hours postdose |
| Time to Maximum Concentration (Tmax) of DOR in Breast Milk | Breast milk samples will be collected to determine the Tmax of DOR | Predose and at designated timepoints up to 24 hours postdose |
| AUC0-24hrs of Total ISL in Breast Milk | Breast milk samples will be collected to determine the AUC0-24hrs of total ISL. | Predose and at designated timepoints up to 24 hours postdose |
| Cmax of Total ISL in Breast Milk | Breast milk samples will be collected to determine the Cmax of total ISL. | Predose and at designated timepoints up to 24 hours postdose |
| Tmax of Total ISL in Breast Milk | Breast milk samples will be collected to determine the Tmax of total ISL. | Predose and at designated timepoints up to 24 hours postdose |
| AUC0-24hrs of DOR in Plasma | Plasma samples will be collected to determine the AUC0-24hrs of DOR. | Predose and at designated timepoints up to 24 hours postdose |
| Cmax of DOR in Plasma | Plasma samples will be collected to determine the Cmax of DOR. | Predose and at designated timepoints up to 24 hours postdose |
| Tmax of DOR in Plasma | Plasma samples will be collected to determine the Tmax of DOR. | Predose and at designated timepoints up to 24 hours postdose |
| Concentration at 24 Hours (C24) of DOR in Plasma | Plasma samples will be collected to determine the C24 of DOR. | Predose and at designated timepoints up to 24 hours postdose |
| AUC0-24hrs of ISL in Plasma | Plasma samples will be collected to determine the AUC0-24hrs of ISL. | Predose and at designated timepoints up to 24 hours postdose |
| Cmax of ISL in Plasma | Plasma samples will be collected to determine the Cmax of ISL. | Predose and at designated timepoints up to 24 hours postdose |
| Tmax of ISL in Plasma | Plasma samples will be collected to determine the Tmax of ISL. | Predose and at designated timepoints up to 24 hours postdose |
| C24 of ISL in Plasma | Plasma samples will be collected to determine the C24 of ISL. | Predose and at designated timepoints up to 24 hours postdose |