Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,600
- 试验地点
- 22
- 主要终点
- M/P ratio
研究概览
简要总结
Over half of women in the US who are breastfeeding their infants take prescription drugs. You are being asked to participate in this study because you are breastfeeding your infant and are currently taking, as part of your medical care, at least one of the drugs we are studying. We are interested in studying drugs commonly prescribed to women who are breastfeeding so we can learn more about the amount of drug that is transferred to breastmilk and estimate how much of drug that is consumed by breastfed infants.
详细描述
The purpose of this study is to understand if the study drugs of interest are found in breastmilk and how much; to estimate the amount of drug that is consumed by breastfed infants and what effect this may have on infants; and to share what we learn with other researchers. The study drugs of interest have Food and Drug Administration (FDA) approval, but there is little or no information about the amount of drug found in the breastmilk of mothers who take them; the amount of drug that may be transferred to their infant's through breastmilk; or the effects this transfer may have on their infants. During this study we will ask to collect breastmilk and blood from mothers, and blood from infants, to measure the amount of study drug of interest in these body fluids. Results from this study will help researchers better understand how much of the study drug of interest is in your blood and breastmilk, and how much of the study drug of interest may be in your infant's blood because of breastfeeding.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lactating women who are receiving at least one DOI per SOC who are ≤180 days postpartum, and their infants (≤180 days of age) who receive maternal breastmilk.
- •Informed consent/HIPAA obtained, according to local IRB/REB/IEC guidelines, prior to any study-related procedures. Lactating women who are not legal adults and their breastfed infants may be enrolled if they assent to participate in the study and consent is obtained from their legal guardian according to local IRB/REB/IEC guidelines.
排除标准
- •Any concomitant condition which, in the opinion of the physicians providing patient care or the principal investigator conducting the study, would preclude a subject's participation in the study.
- •Known pregnancy during PK sampling.
研究组 & 干预措施
labetalol
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: labetalol (Drug)
metformin
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: metformin (Drug)
nifedipine
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: nifedipine (Drug)
oxycodone
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: oxycodone (Drug)
clindamycin
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: clindamycin (Drug)
azithromycin
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: azithromycin (Drug)
escitalopram
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: escitalopram (Drug)
sertraline
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: sertraline (Drug)
Ciprofloxacin
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Ciprofloxacin (Drug)
ondansetron
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: ondansetron (Drug)
Doxycycline
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Doxycycline (Drug)
Levofloxacin
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Levofloxacin (Drug)
Methylphenidate
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Methylphenidate (Drug)
Citalopram
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Citalopram (Drug)
Sumatriptan
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Sumatriptan (Drug)
Cyclobenzaprine
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Cyclobenzaprine (Drug)
Furosemide
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Furosemide (Drug)
Rosuvastatin
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Rosuvastatin (Drug)
Gabapentin
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Gabapentin (Drug)
Hydrochlorothiazide
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Hydrochlorothiazide (Drug)
Hydroxyurea
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Hydroxyurea (Drug)
Topiramate
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Topiramate (Drug)
Trazodone
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Trazodone (Drug)
Valganciclovir
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Valganciclovir (Drug)
Remdesivir
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Remdesivir (Drug)
Venlafaxine
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Venlafaxine (Drug)
Verapamil
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Verapamil (Drug)
Fluvoxamine
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Fluvoxamine (Drug)
Anakinra
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Anakinra (Drug)
Tocilizumab
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Tocilizumab (Drug)
Amoxicillin
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Amoxicillin (Drug)
Bupropion
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Bupropion (Drug)
Buprenorphine
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Buprenorphine (Drug)
Hydrocodone
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Hydrocodone (Drug)
Levetiracetam
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Levetiracetam (Drug)
Paroxetine
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Paroxetine (Drug)
Duloxetine
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Duloxetine (Drug)
Tranexamic acid (TXA)
No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
干预措施: Tranexamic acid (TXA) (Drug)
结局指标
主要结局
M/P ratio
时间窗: Until the infant becomes 180 days of age
Characterize the pharmacokinetics using maternal milk/plasma exposure ratio is calculated by dividing the BMS01 drug of interest breastmilk concentration by the BMS01 drug of interest in maternal plasma concentration.
RID
时间窗: Until the infant becomes 180 days of age
Pharmacokinetics is characterized by relative infant dose is a method of relating the potential dose of the drug delivered to the infant to the typical therapeutic dose given to the mother.
I/M ratio
时间窗: Until the infant becomes 180 days of age
Pharmacokinetics is characterized using infant maternal/exposure ratio. IM ratio is calculated using the average infant plasma concentration of the BMS01 drug of interest and historical value of clearance in infants.
DID
时间窗: Until the infant becomes 180 days of age
Pharmacokinetics is characterized by estimated daily infant dose-daily infant dose which estimates the quantity of drug delivered to an infant via breastmilk in a given day.
次要结局
- AE(Up until 180 days of age)
- ESI(Until the infant becomes 180 days of age)
- Safety profile of commonly used drugs in infants exposed to drugs in breastmilk(Until the infant becomes 180 days of age)
- SAE(Up until 180 days of age)
研究者
Kanecia Obie Zimmerman
Associate Professor of Pediatrics
Duke University