Healthy
Conditions
Brief summary
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.
Interventions
DRUGDOR/ISL
Oral tablet
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 main inclusion criteria include but are not limited to the following: * Is at least 6-weeks postpartum at the time of administration of study drug, following the delivery of a healthy singleton neonate * Is willing and able to express breast milk using an electric pump prior to study drug administration and is expected to be able to express at least 4 times over a 24-hour period after study drug administration
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Amount of DOR Excreted in Breast Milk From 0 to 24 Hours (Ae0-24hrs) | Predose and at designated timepoints up to 24 hours postdose | Breast milk samples will be collected to determine the Ae0-24hrs after administration of DOR. |
| Body Weight Normalized Infant Theoretical Dose of DOR | Predose and at designated timepoints up to 24 hours postdose | 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. |
| Relative Infant Theoretical Dose of DOR | Predose and at designated timepoints up to 24 hours postdose | Breast milk samples will be collected to calculate the theoretical daily (24 hour) infant dose of DOR relative to the maternal dose. |
| Cumulative Amount of Total ISL Excreted in Breast Milk From 0 to 24 Hours (Ae0-24hrs) | Predose and at designated timepoints up to 24 hours postdose | Breast milk samples will be collected to determine the Ae0-24hrs after administration of total ISL. |
| Body Weight Normalized Infant Theoretical Dose of ISL | Predose and at designated timepoints up to 24 hours postdose | 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. |
| Relative Infant Theoretical Dose of ISL | Predose and at designated timepoints up to 24 hours postdose | Breast milk samples will be collected to calculate the theoretical daily (24 hour) infant dose of ISL relative to the maternal dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve From 0 to 24 Hours (AUC0-24hrs) of DOR in Breast Milk | Predose and at designated timepoints up to 24 hours postdose | Breast milk samples will be collected to determine the AUC0-24hrs of DOR. |
| Maximum Concentration (Cmax) of DOR in Breast Milk | Predose and at designated timepoints up to 24 hours postdose | Breast milk samples will be collected to determine the Cmax of DOR. |
| Time to Maximum Concentration (Tmax) of DOR in Breast Milk | Predose and at designated timepoints up to 24 hours postdose | Breast milk samples will be collected to determine the Tmax of DOR |
| AUC0-24hrs of Total ISL in Breast Milk | Predose and at designated timepoints up to 24 hours postdose | Breast milk samples will be collected to determine the AUC0-24hrs of total ISL. |
| Cmax of Total ISL in Breast Milk | Predose and at designated timepoints up to 24 hours postdose | Breast milk samples will be collected to determine the Cmax of total ISL. |
| Tmax of Total ISL in Breast Milk | Predose and at designated timepoints up to 24 hours postdose | Breast milk samples will be collected to determine the Tmax of total ISL. |
| AUC0-24hrs of DOR in Plasma | Predose and at designated timepoints up to 24 hours postdose | Plasma samples will be collected to determine the AUC0-24hrs of DOR. |
| Cmax of DOR in Plasma | Predose and at designated timepoints up to 24 hours postdose | Plasma samples will be collected to determine the Cmax of DOR. |
| Tmax of DOR in Plasma | Predose and at designated timepoints up to 24 hours postdose | Plasma samples will be collected to determine the Tmax of DOR. |
| Concentration at 24 Hours (C24) of DOR in Plasma | Predose and at designated timepoints up to 24 hours postdose | Plasma samples will be collected to determine the C24 of DOR. |
| AUC0-24hrs of ISL in Plasma | Predose and at designated timepoints up to 24 hours postdose | Plasma samples will be collected to determine the AUC0-24hrs of ISL. |
| Cmax of ISL in Plasma | Predose and at designated timepoints up to 24 hours postdose | Plasma samples will be collected to determine the Cmax of ISL. |
| Tmax of ISL in Plasma | Predose and at designated timepoints up to 24 hours postdose | Plasma samples will be collected to determine the Tmax of ISL. |
| C24 of ISL in Plasma | Predose and at designated timepoints up to 24 hours postdose | Plasma samples will be collected to determine the C24 of ISL. |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed