University of Texas Medical Branch

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

Purpose

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.

Conditions

Lactating Women on Select DOI
Breastfed Infants of Mothers on Select DOI

Eligibility

Eligible Ages: All ages
Eligible Genders: All
Accepts Healthy Volunteers: No

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.

Study Design

Phase
Study Type: Observational
Observational Model: Other
Time Perspective: Prospective

Arm Groups

Arm	Description	Assigned Intervention
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.	Drug: Tranexamic acid (TXA) Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: labetalol Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: metformin Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: nifedipine Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: clindamycin Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: oxycodone Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: azithromycin Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: escitalopram Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: sertraline Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: ondansetron Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Ciprofloxacin Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Doxycycline Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Levofloxacin Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Methylphenidate Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Sumatriptan Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Citalopram Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Cyclobenzaprine Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Furosemide Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Gabapentin Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Hydrochlorothiazide Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Hydroxyurea Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Rosuvastatin Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Topiramate Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Trazodone Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Valganciclovir Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Venlafaxine Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Verapamil Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Remdesivir Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Anakinra Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Tocilizumab Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Fluvoxamine Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Amoxicillin Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Bupropion Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Buprenorphine Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Hydrocodone Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Levetiracetam Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Paroxetine Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
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.	Drug: Duloxetine Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Recruiting Locations

University of Texas Medical Branch - Galveston
Galveston, Texas 77555

Contact:
Leah McCoy
409-747-1761
lemccoy@utmb.edu

More Details

Status: Recruiting
Sponsor: Duke University

Study Contact

Emily Forgey
919-660-8720
emily.forgey@duke.edu

Detailed 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.