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.

Study Overview

• Status: Recruiting
• Conditions: Lactating Women on Select DOI; Breastfed Infants of Mothers on Select DOI
• Intervention / Treatment: Drug: Tranexamic acid (TXA); Drug: labetalol; Drug: metformin; Drug: nifedipine; Drug: clindamycin; Drug: oxycodone; Drug: azithromycin; Drug: escitalopram; Drug: sertraline; Drug: ondansetron; Drug: Ciprofloxacin; Drug: Doxycycline; Drug: Levofloxacin; Drug: Methylphenidate; Drug: Sumatriptan; Drug: Citalopram; Drug: Cyclobenzaprine; Drug: Furosemide; Drug: Gabapentin; Drug: Hydrochlorothiazide; Drug: Hydroxyurea; Drug: Rosuvastatin; Drug: Topiramate; Drug: Trazodone; Drug: Valganciclovir; Drug: Venlafaxine; Drug: Verapamil; Drug: Remdesivir; Drug: Anakinra; Drug: Tocilizumab; Drug: Fluvoxamine; Drug: Amoxicillin; Drug: Bupropion; Drug: Buprenorphine; Drug: Hydrocodone; Drug: Levetiracetam; Drug: Paroxetine; Drug: Duloxetine

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.

• Study Type: Observational
• Enrollment (Estimated): 1600

Contacts and Locations

• Study Contact: Name: Cheryl Alderman; Phone Number: 919-966-8349; Email: cheryl.alderman@duke.edu
• Study Contact Backup: Name: Allyn Damman; Phone Number: 919-259-4414; Email: allyn.meredith@duke.edu

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • Completed
      • Lawson Health Research Institute
  • Quebec
    • Montreal, Quebec, Canada, H3T IC5
      • Completed
      • Centre Hospitalier Universitaire Sainte-Justine
• United States
  • California
    • La Jolla, California, United States, 92093
      • Recruiting
      • University of California-San Diego Medical Center
      • Contact: Kerri Bertrand; Phone Number: 858-246-1713; Email: kdutcher@ucsd.edu
      • Contact: Gretchen Bandoli; Phone Number: 858-246-1733; Email: gbandoli@ucsd.edu
      • Principal Investigator: Christina Chambers, PhD
      • Sub-Investigator: Michelle Leff
    • Loma Linda, California, United States, 92354
      • Recruiting
      • Loma Linda University Health
      • Contact: Jose Navarro; Phone Number: 909-558-5830; Email: jdnavarro@llu.edu
      • Contact: Stephanie Wells; Phone Number: 909-558-5830; Email: scwells@llu.edu
      • Sub-Investigator: Adrian Lavery
      • Principal Investigator: Larry Ngo
  • Illinois
    • Chicago, Illinois, United States, 60614
      • Recruiting
      • Ann and Robert H. Lurie Childrens Hospital of Chicago
      • Contact: Laura Fearn; Phone Number: 312-227-6280; Email: lfearn@luriechildrens.org
      • Contact: Mayra Gomez; Phone Number: 312-227-8274; Email: mmgomez@luriechildrens.org
      • Principal Investigator: William Muller, MD
    • Chicago, Illinois, United States, 60611
      • Completed
      • Northwestern University
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Completed
      • Indiana University Health
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Active, not recruiting
      • University of Iowa Hospitals and Clinics
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Recruiting
      • Children's Hospital and Clinics - Minneapolis
      • Principal Investigator: Andrea Lampland, MD
      • Contact: Quast Emily; Phone Number: 612-813-6864; Email: emily.quast@childrensmn.org
      • Contact: Molly fisher; Phone Number: 612-813-6864; Email: molly.fisher@childrensmn.org
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • Completed
      • University of New Mexico, Health Sciences Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Completed
      • University of North Carolina Hospital
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Duke University Maternal and Fetal Medicine
      • Contact: Thelma Fitzgerald; Phone Number: 919-684-1224; Email: thelma.fitzgerald@duke.edu
      • Principal Investigator: Brenna Hughes, MD
      • Contact: Jordynn Akins; Phone Number: 919-681-0013; Email: jordynn.akins@duke.edu
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University
      • Contact: Monica Rincon; Phone Number: 503-494-8748; Email: rincon@ohsu.edu
      • Principal Investigator: Nicole Marshall
      • Contact: Daniela Cramer; Phone Number: 503-494-8742; Email: cramerda@ohsu.edu
      • Sub-Investigator: Karen Gibbins
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Completed
      • Hospital of the University of Pennsylvania Department of Maternal Fetal Medicine
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh School of Medicine
      • Principal Investigator: Anne-Marie Rick, MD
      • Contact: Leigh Ann Shaver; Email: shaverla2@upmc.edu
  • Texas
    • Amarillo, Texas, United States, 79106
      • Recruiting
      • Texas Tech University Health Sciences Center School of Medicine.
      • Principal Investigator: Kaytlin Krutsch, PharnD
      • Sub-Investigator: Teresa Baker, MD
      • Contact: Katie Boatler; Email: katie.boatler@ttuhsc.edu
    • Galveston, Texas, United States, 77555
      • Recruiting
      • University of Texas Medical Branch - Galveston
      • Contact: Lizzet Aguillon; Phone Number: 409-772-0305; Email: liaguill@utmb.edu
      • Principal Investigator: Gayle Olson, MD
      • Contact: Sashank Komanduri; Email: sakomand@utmb.edu
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas Health Science Center at Houston
      • Principal Investigator: Pamela Berens, MD
      • Contact: Felicia Ortiz; Phone Number: 1-713-500-6467; Email: felecia.ortiz@uth.tmc.edu
    • Houston, Texas, United States, 77054
      • Recruiting
      • The Women's Hospital of Texas
      • Principal Investigator: Olaide Balogun, MD
      • Contact: Olaide Balogun; Email: olaide.ashimibalogun@pediatrix.comare.com
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • University of Texas Health Science Center
      • Principal Investigator: Olaide Balogun, MD
      • Sub-Investigator: Kaashif Ahmad, MD
      • Contact: Janette Rodela, RN; Phone Number: (615) 344-9551; Email: Janette.Rodela@HCAhealthcare.com
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Recruiting
      • University of Utah
      • Principal Investigator: Kathleen Job
      • Sub-Investigator: Lauren Theilen
      • Contact: Kelly Christensen; Phone Number: 801-674-7234; Email: kelly.vorwaller@hsc.utah.edu
  • Washington
    • Seattle, Washington, United States, 98195-7630
      • Completed
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Lactating women receiving DOIs per SOC, as prescribed by their healthcare providers, and their breastfed infants.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

38

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
M/P ratio	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.	Until the infant becomes 180 days of age
DID	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.	Until the infant becomes 180 days of age
RID	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.	Until the infant becomes 180 days of age
I/M ratio	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.	Until the infant becomes 180 days of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety profile of commonly used drugs in infants exposed to drugs in breastmilk	see Cohort 1-31 for listing of drugs	Until the infant becomes 180 days of age
AE	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.	Up until 180 days of age
SAE	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.	Up until 180 days of age
ESI	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	Until the infant becomes 180 days of age

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); The Emmes Company, LLC
• Investigators: Principal Investigator: Samia Aleem, MD, Duke University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2018
• Primary Completion (Estimated): July 23, 2027
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: April 23, 2018
• First Submitted That Met QC Criteria: April 23, 2018
• First Posted (Actual): April 27, 2018

Study Record Updates

• Last Update Posted (Actual): July 29, 2026
• Last Update Submitted That Met QC Criteria: July 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Peptides; Amino Acids, Peptides, and Proteins; Proteins; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Lipids; Azoles; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Biological Factors; Carbohydrates; Acids, Acyclic; Carboxylic Acids; Alkaloids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glycosides; Imidazoles; Amides; Aniline Compounds; Amines; Piperidines; Indoles; Guanine; Hypoxanthines; Purinones; Purines; Amino Acids; Pyrimidines; Nitriles; Alcohols; Macrolides; Lactones; Hydrocarbons, Halogenated; Intercellular Signaling Peptides and Proteins; Naphthacenes; Heterocyclic Compounds, 4 or More Rings; Amino Alcohols; Ethanolamines; Phenethylamines; Ethylamines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Sugars; Pyrrolidines; Tetracyclines; Lincomycin; Lincosamides; Biguanides; Guanidines; Amidines; Acids, Carbocyclic; Penicillin G; beta-Lactams; Lactams; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Ofloxacin; Acetamides; Acetates; Sulfonamides; Sulfanilamides; Sulfones; Thiophenes; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Hydroxylamines; Cytokines; Erythromycin; Polyketides; Morphine Derivatives; Heterocyclic Compounds, 3-Ring; Propylamines; Ketones; Tryptamines; Fluorobenzenes; Hydrocarbons, Fluorinated; Cyclohexanecarboxylic Acids; Ampicillin; Penicillins; Codeine; Piperazines; Phenylacetates; Urea; Ganciclovir; Acyclovir; Cyclohexanols; Hexanols; Fatty Alcohols; Hexoses; Monosaccharides; Carbazoles; Pyridones; Pyrrolidinones; Fructose; Ketoses; Chlorothiazide; Benzothiadiazines; Thiazides; Dihydropyridines; Propiophenones; Benzofurans; 1-Naphthylamine; Oximes; Salicylamides; Duloxetine Hydrochloride; Gabapentin; Rosuvastatin Calcium; Valganciclovir; Venlafaxine Hydrochloride; Levetiracetam; Topiramate; Escitalopram; Tranexamic Acid; Methylphenidate; Metformin; Amoxicillin; Doxycycline; Ondansetron; Furosemide; Interleukin 1 Receptor Antagonist Protein; Buprenorphine; Azithromycin; Bupropion; Sumatriptan; Clindamycin; Hydroxyurea; Nifedipine; Oxycodone; Hydrochlorothiazide; Verapamil; Citalopram; Paroxetine; Levofloxacin; Sertraline; Fluvoxamine; Hydrocodone; Labetalol; Ciprofloxacin; Trazodone; tocilizumab; remdesivir; cyclobenzaprine
• Other Study ID Numbers: Pro00088919; HHSN275201000003I/27500051 (Other Grant/Funding Number: NICHD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No