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NCT Number: NCT03511118

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

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.

Recruiting

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Lawson Health Research Institute, London, Ontario, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tranexamic acid (TXA)

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

labetalol

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

metformin

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

nifedipine

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Clindamycin

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Oxycodone

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Azithromycin

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Escitalopram

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Sertraline

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

ondansetron

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Ciprofloxacin

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Doxycycline

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Levofloxacin

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Methylphenidate

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Sumatriptan

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Citalopram

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Cyclobenzaprine

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Furosemide

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Gabapentin

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Hydrochlorothiazide

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Hydroxyurea

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Rosuvastatin

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Topiramate

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Trazodone

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Valganciclovir

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Venlafaxine

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Verapamil

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Remdesivir

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Anakinra

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Tocilizumab

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Fluvoxamine

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Amoxicillin

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

bupropion

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Duloxetine

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Hydrocodone

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Levetiracetam

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

paroxetine

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

buprenorphine

Drug

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Primary outcomes

  1. M/P ratio

    Time frame: 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.

  2. DID

    Time frame: 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.

  3. RID

    Time frame: 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.

  4. I/M ratio

    Time frame: 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.

Secondary outcomes

  1. Safety profile of commonly used drugs in infants exposed to drugs in breastmilk

    Time frame: Until the infant becomes 180 days of age

    see Cohort 1-31 for listing of drugs

  2. AE

    Time frame: Up until 180 days of age

    Safety profile of commonly used drugs in infants exposed to drugs in breastmilk is characterized by Adverse Events(AE) which are collected at each time point when the study-specific procedure occurred and up until 1 hour after.

  3. SAE

    Time frame: Up until 180 days of age

    Safety profile of commonly used drugs in infants exposed to drugs in breastmilk is characterized by Serious Adverse Events which are directly related to study procedures and were recorded from participants (infant or mother) at each time point when the study-specific procedure occurred and up until 1 hour after.

  4. ESI

    Time frame: Until the infant becomes 180 days of age

    Safety profile of commonly used drugs in infants exposed to drugs in breastmilk is characterized by Events of Special Interest(ESI) which include any pre-specified safety event that could be related to BMS01 drug of interest exposure. ESI's are only assessed for infants and only at study visits from the time the BMS01 DOI was initiated in mother and infant began breast milk feeding through the end of the study / infant age ≤ 180 days

Study contacts

Contact information is provided by the study sponsor or research team.

Cheryl Alderman

CONTACT

[email protected]

919-966-8349

Emily Forgey

CONTACT

[email protected]

919-660-8720

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • The Emmes Company, LLC

Registry information

Important dates

Study start
2018
Primary completion
2027
Study completion
2028
First posted
Apr 27, 2018
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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