Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
Status
Enrolling
Conditions
Breastfed Infants of Mothers on Select DOI
Lactating Women on Select DOI
Treatments
Drug: Verapamil
Drug: clindamycin
Drug: Levetiracetam
Drug: Rosuvastatin
Drug: Hydroxyurea
Drug: Hydrochlorothiazide
Drug: Remdesivir
Drug: metformin
Drug: sertraline
Drug: labetalol
Drug: Bupropion
Drug: Doxycycline
Drug: Sumatriptan
Drug: Citalopram
Drug: Levofloxacin
Drug: Fluvoxamine
Drug: Tocilizumab
Drug: Cyclobenzaprine
Drug: Valganciclovir
Drug: Topiramate
Drug: oxycodone
Drug: Amoxicillin
Drug: Trazodone
Drug: nifedipine
Drug: Anakinra
Drug: Ciprofloxacin
Drug: Paroxetine
Drug: azithromycin
Drug: escitalopram
Drug: Duloxetine
Drug: Gabapentin
Drug: Venlafaxine
Drug: ondansetron
Drug: Hydrocodone
Drug: Tranexamic acid (TXA)
Drug: Furosemide
Drug: Buprenorphine
Drug: Methylphenidate
Study type
Observational
Funder types
Other
Industry
NIH
Identifiers
Details and patient eligibility
About
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.
Full description
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.
Enrollment
1,600 estimated patients
Sex
All
Volunteers
No Healthy Volunteers
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Trial design
1,600 participants in 38 patient groups
Tranexamic acid (TXA)
Description:
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.
Treatment:
Drug: Tranexamic acid (TXA)
labetalol
Description:
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.
Treatment:
Drug: labetalol
metformin
Description:
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.
Treatment:
Drug: metformin
nifedipine
Description:
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.
Treatment:
Drug: nifedipine
clindamycin
Description:
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.
Treatment:
Drug: clindamycin
oxycodone
Description:
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.
Treatment:
Drug: oxycodone
azithromycin
Description:
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.
Treatment:
Drug: azithromycin
escitalopram
Description:
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.
Treatment:
Drug: escitalopram
sertraline
Description:
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.
Treatment:
Drug: sertraline
ondansetron
Description:
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.
Treatment:
Drug: ondansetron
Ciprofloxacin
Description:
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.
Treatment:
Drug: Ciprofloxacin
Doxycycline
Description:
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.
Treatment:
Drug: Doxycycline
Levofloxacin
Description:
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.
Treatment:
Drug: Levofloxacin
Methylphenidate
Description:
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.
Treatment:
Drug: Methylphenidate
Sumatriptan
Description:
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.
Treatment:
Drug: Sumatriptan
Citalopram
Description:
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.
Treatment:
Drug: Citalopram
Cyclobenzaprine
Description:
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.
Treatment:
Drug: Cyclobenzaprine
Furosemide
Description:
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.
Treatment:
Drug: Furosemide
Gabapentin
Description:
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.
Treatment:
Drug: Gabapentin
Hydrochlorothiazide
Description:
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.
Treatment:
Drug: Hydrochlorothiazide
Hydroxyurea
Description:
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.
Treatment:
Drug: Hydroxyurea
Rosuvastatin
Description:
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.
Treatment:
Drug: Rosuvastatin
Topiramate
Description:
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.
Treatment:
Drug: Topiramate
Trazodone
Description:
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.
Treatment:
Drug: Trazodone
Valganciclovir
Description:
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.
Treatment:
Drug: Valganciclovir
Venlafaxine
Description:
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.
Treatment:
Drug: Venlafaxine
Verapamil
Description:
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.
Treatment:
Drug: Verapamil
Remdesivir
Description:
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.
Treatment:
Drug: Remdesivir
Anakinra
Description:
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.
Treatment:
Drug: Anakinra
Tocilizumab
Description:
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.
Treatment:
Drug: Tocilizumab
Fluvoxamine
Description:
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.
Treatment:
Drug: Fluvoxamine
Amoxicillin
Description:
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.
Treatment:
Drug: Amoxicillin
Bupropion
Description:
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.
Treatment:
Drug: Bupropion
Buprenorphine
Description:
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.
Treatment:
Drug: Buprenorphine
Hydrocodone
Description:
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.
Treatment:
Drug: Hydrocodone
Levetiracetam
Description:
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.
Treatment:
Drug: Levetiracetam
Paroxetine
Description:
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.
Treatment:
Drug: Paroxetine
Duloxetine
Description:
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.
Treatment:
Drug: Duloxetine
Trial contacts and locations
22
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Central trial contact
Emily Forgey; Cheryl Alderman
Data sourced from clinicaltrials.gov
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