Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Tranexamic acid (TXA)
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Препарат labetalol
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Препарат metformin
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Препарат nifedipine
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Препарат clindamycin
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Препарат oxycodone
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Препарат azithromycin
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Препарат escitalopram
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Препарат sertraline
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Препарат ondansetron
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Первичные конечные точки

• M/P ratio [Срок оценки: Until the infant becomes 180 days of age]
• DID [Срок оценки: Until the infant becomes 180 days of age]
• RID [Срок оценки: Until the infant becomes 180 days of age]
• I/M ratio [Срок оценки: Until the infant becomes 180 days of age]

Вторичные конечные точки (4)

• Safety profile of commonly used drugs in infants exposed to drugs in breastmilk [Срок оценки: Until the infant becomes 180 days of age]
• AE [Срок оценки: Up until 180 days of age]
• SAE [Срок оценки: Up until 180 days of age]
• ESI [Срок оценки: Until the infant becomes 180 days of age]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

США · 20 центров

• University of California-San Diego Medical Center — La Jolla
• Loma Linda University Health — Loma Linda
• Northwestern University — Chicago
• Ann and Robert H. Lurie Childrens Hospital of Chicago — Chicago
• Indiana University Health — Indianapolis
• University of Iowa Hospitals and Clinics — Iowa City
• Children's Hospital and Clinics - Minneapolis — Minneapolis
• University of New Mexico, Health Sciences Center — Albuquerque
• … и ещё 12 центров

Канада · 2 центра

• Lawson Health Research Institute — London
• Centre Hospitalier Universitaire Sainte-Justine — Montreal

Публикации

• Job KM, Dallmann A, Parry S, Saade G, Haas DM, Hughes B, Berens P, Chen JY, Fu C, Humphrey K, Hornik C, Balevic S, Zimmerman K, Watt K. Development of a Generic Physiologically-Based Pharmacokinetic Model for Lactation and Prediction of Maternal and Infant Exposure to Ondansetron via Breast Milk. Clin Pharmacol Ther. 2022 May;111(5):1111-1120. doi: 10.1002/cpt.2530. Epub 2022 Mar 5. PMID 35076931

Идентификаторы

NCT: NCT03511118 · Pro00088919 · HHSN275201000003I/27500051

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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