A Clinical Study to Evaluate the Breast Milk and Plasma Pharmacokinetics of MK-8591A in Healthy Lactating Female Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Cumulative Amount of DOR Excreted in Breast Milk From 0 to 24 Hours (Ae0-24hrs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
DOR/ISL
Participants will receive DOR/ISL as an oral fixed-dose combination tablet once daily on Days 1 to 7.
干预措施: DOR/ISL (Drug)
结局指标
主要结局
Cumulative Amount of DOR Excreted in Breast Milk From 0 to 24 Hours (Ae0-24hrs)
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Maximum Concentration (Cmax) of DOR in Breast Milk(Predose and at designated timepoints up to 24 hours postdose)
- Time to Maximum Concentration (Tmax) of DOR in Breast Milk(Predose and at designated timepoints up to 24 hours postdose)
- AUC0-24hrs of Total ISL in Breast Milk(Predose and at designated timepoints up to 24 hours postdose)
- Cmax of Total ISL in Breast Milk(Predose and at designated timepoints up to 24 hours postdose)
- Tmax of Total ISL in Breast Milk(Predose and at designated timepoints up to 24 hours postdose)
- AUC0-24hrs of DOR in Plasma(Predose and at designated timepoints up to 24 hours postdose)
- Cmax of DOR in Plasma(Predose and at designated timepoints up to 24 hours postdose)
- Tmax of DOR in Plasma(Predose and at designated timepoints up to 24 hours postdose)
- Concentration at 24 Hours (C24) of DOR in Plasma(Predose and at designated timepoints up to 24 hours postdose)
- AUC0-24hrs of ISL in Plasma(Predose and at designated timepoints up to 24 hours postdose)
- Cmax of ISL in Plasma(Predose and at designated timepoints up to 24 hours postdose)
- Tmax of ISL in Plasma(Predose and at designated timepoints up to 24 hours postdose)
- C24 of ISL in Plasma(Predose and at designated timepoints up to 24 hours postdose)