A Study of Doravirine/Islatravir in Healthy Lactating Females (MK-8591A-061)
- Conditions
- Healthy
- Interventions
- Drug: DOR/ISL
- Registration Number
- NCT07086079
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 12
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
The main exclusion criteria include but are not limited to the following:
- Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, psychiatric, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Has had mastitis within 30 days prior to administration of study drug
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DOR/ISL DOR/ISL Participants will receive DOR/ISL as an oral fixed-dose combination tablet once daily on Days 1 to 7.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.