NCT06580587已完成1 期
A Clinical Study to Evaluate the Breast Milk, Plasma and Whole Blood Pharmacokinetics of MK-8527 in Healthy Lactating Female Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 3
- 主要终点
- 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
研究概览
简要总结
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.
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 key inclusion criteria include but are not limited to the following:
- •Is at least 6 weeks postpartum at the time of administration of study intervention, following the delivery of a healthy singleton neonate
- •Is willing and able to express breast milk at least twice daily for at least 120 hours after enrollment
- •Is willing to discontinue breastfeeding from the time of administration of study intervention until at least 6 weeks following the administration of study intervention. This includes the avoidance of both directly breastfeeding and the administration of breast milk pumped during the above-specified time frame to the infant. Is willing to confirm with the site that the infant is able to bottle feed (breast milk) prior to Day 1 and that alternative nutrition (i.e., previously stored breast milk or infant formula) is available for feeding the infant through the 6-week post dose period
排除标准
- •The key exclusion criteria include but are not limited to the following
- •Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, psychiatric, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- •Had mastitis within 30 days prior to administration of study drug
- •Has a positive pregnancy test at the time of screening or prior to treatment allocation
研究组 & 干预措施
MK-8527
Experimental
Participants receive single oral dose of MK-8527 on Day 1
干预措施: MK-8527 (Drug)
结局指标
主要结局
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
时间窗: Predose and at designated timepoints up to 120 hours postdose
Breast milk samples will be collected to determine the AUC0-120hrs after administration of a single oral dose of MK-8527.
Maximum Breast Milk Concentration (Cmax) After Administration of a Single Oral Dose of MK-8527
时间窗: Predose and at designated timepoints up to 21 days postdose
Breast milk samples will be collected to determine the Cmax after administration of a single oral dose of MK-8527.
Time to Maximum Breast Milk Concentration (Tmax) After Administration of a Single Oral Dose of MK-8527
时间窗: Predose and at designated timepoints up to 21 days postdose
Breast milk samples will be collected to determine the Tmax after administration of a single oral dose of MK-8527.
次要结局
- Mean Concentration of MK-8527 in Breast Milk After Administration of a Single Oral Dose(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(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(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(Predose and at designated timepoints up to 21 days postdose)
- Maximum Blood Concentration (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(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(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(Predose and at designated timepoints up to 7 days postdose)
- Maximum Plasma Concentration (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(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(At designated timepoints up to 120 hours postdose)
- Ratio of MK-8527 in Breast Milk to Plasma After Administration of a Single Oral Dose(At designated timepoints up to 120 hours postdose)
研究者
研究点 (3)
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