Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
NCT ID: NCT03511118
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1600 participants
OBSERVATIONAL
2018-10-04
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Duloxetine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Interventions
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Tranexamic acid (TXA)
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
labetalol
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
metformin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
nifedipine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
clindamycin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
oxycodone
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
azithromycin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
escitalopram
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
sertraline
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
ondansetron
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Ciprofloxacin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Doxycycline
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Levofloxacin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Methylphenidate
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Sumatriptan
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Citalopram
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Cyclobenzaprine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Furosemide
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Gabapentin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Hydrochlorothiazide
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Hydroxyurea
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Rosuvastatin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Topiramate
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Trazodone
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Valganciclovir
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Venlafaxine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Verapamil
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Remdesivir
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Anakinra
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Tocilizumab
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Fluvoxamine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Amoxicillin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Bupropion
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Duloxetine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Hydrocodone
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Levetiracetam
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Paroxetine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Buprenorphine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Eligibility Criteria
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Inclusion Criteria
* 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
* Known pregnancy during PK sampling.
ALL
No
Sponsors
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The Emmes Company, LLC
INDUSTRY
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Duke University
OTHER
Responsible Party
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Kanecia Obie Zimmerman
Associate Professor of Pediatrics
Principal Investigators
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Kanecia Zimmerman, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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University of California-San Diego Medical Center
La Jolla, California, United States
Loma Linda University Health
Loma Linda, California, United States
Northwestern University
Chicago, Illinois, United States
Ann and Robert H. Lurie Childrens Hospital of Chicago
Chicago, Illinois, United States
Indiana University Health
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Children's Hospital and Clinics - Minneapolis
Minneapolis, Minnesota, United States
University of New Mexico, Health Sciences Center
Albuquerque, New Mexico, United States
University of North Carolina Hospital
Chapel Hill, North Carolina, United States
Duke University Maternal and Fetal Medicine
Durham, North Carolina, United States
Oregon Health & Science University
Portland, Oregon, United States
Hospital of the University of Pennsylvania Department of Maternal Fetal Medicine
Philadelphia, Pennsylvania, United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States
Texas Tech University Health Sciences Center School of Medicine.
Amarillo, Texas, United States
University of Texas Medical Branch - Galveston
Galveston, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
The Women's Hospital of Texas
Houston, Texas, United States
University of Texas Health Science Center
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Washington
Seattle, Washington, United States
Lawson Health Research Institute
London, Ontario, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Kerri Bertrand
Role: primary
Gretchen Bandoli
Role: backup
Jose Navarro
Role: primary
Stephanie Wells
Role: backup
Laura Fearn
Role: primary
Mayra Gomez
Role: backup
Beverly Vermace
Role: primary
Maureen Austin
Role: backup
Quast Emily
Role: primary
Molly fisher
Role: backup
Thelma Fitzgerald
Role: primary
Jordynn Akins
Role: backup
Monica Rincon
Role: primary
Daniela Cramer
Role: backup
Matthew Butoryak
Role: primary
Nichole Campbell, APRN, NP-C
Role: primary
Leah McCoy
Role: primary
Lizzet Aguillon
Role: backup
Josephine Turner
Role: primary
Olaide Balogun, MD
Role: primary
Ashley Lozano
Role: backup
Janette Rodela, RN
Role: primary
Kelly Christensen
Role: primary
References
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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.
Other Identifiers
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HHSN275201000003I/27500051
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Pro00088919
Identifier Type: -
Identifier Source: org_study_id