NCT03511118 · Duke University
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
What this study is 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.
View original scientific description
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.
Interventions
DRUG
Tranexamic acid (TXA)
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
labetalol
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
metformin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
nifedipine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
clindamycin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
oxycodone
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
azithromycin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
escitalopram
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
sertraline
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
ondansetron
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Ciprofloxacin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Doxycycline
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Levofloxacin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Methylphenidate
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Sumatriptan
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Citalopram
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Cyclobenzaprine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Furosemide
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Gabapentin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Hydrochlorothiazide
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Hydroxyurea
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Rosuvastatin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Topiramate
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Trazodone
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Valganciclovir
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Venlafaxine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Verapamil
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Remdesivir
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Anakinra
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Tocilizumab
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Fluvoxamine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Amoxicillin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Bupropion
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Duloxetine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Hydrocodone
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Levetiracetam
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Paroxetine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUG
Buprenorphine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Primary outcome measures
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.
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.
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- La Jolla, California
- Loma Linda, California
- Chicago, Illinois
- Indianapolis, Indiana
- Iowa City, Iowa
- Minneapolis, Minnesota
- Albuquerque, New Mexico
- Chapel Hill, North Carolina
- Durham, North Carolina
- Portland, Oregon
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
And 6 more locations — see the full list below.
Collaborators
The Emmes Company, LLC, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 29, 2026 · Source of record for eligibility and locations