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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03511118
Recruitment Status : Recruiting
First Posted : April 27, 2018
Last Update Posted : June 9, 2022
Sponsor:
Collaborators:
The Emmes Company, LLC
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Kanecia Obie Zimmerman, Duke University

Brief Summary:
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.

Condition or disease Intervention/treatment
Lactating Women on Select DOI Breastfed Infants of Mothers on Select DOI Other: Tranexamic acid (TXA) Other: labetalol Other: metformin Other: nifedipine Other: clindamycin Other: oxycodone Other: azithromycin Other: escitalopram Other: sertraline Other: ondansetron Other: Ciprofloxacin Other: Doxycycline Other: Levofloxacin Other: Methylphenidate Other: Sumatriptan Other: Citalopram Other: Cyclobenzaprine Other: Furosemide Other: Gabapentin Other: Hydrochlorothiazide Other: Hydroxyurea Other: Rosuvastatin Other: Topiramate Other: Trazodone Other: Valganciclovir Other: Venlafaxine Other: Verapamil Other: Remdesivir Other: Anakinra Other: Tocilizumab Other: Fluvoxamine

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.

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Study Type : Observational
Estimated Enrollment : 1600 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : September 23, 2024
Estimated Study Completion Date : September 23, 2024

Resource links provided by the National Library of Medicine


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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

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




Primary Outcome Measures :
  1. Pharmacokinetics of commonly used drugs in the blood and breastmilk of lactating women and in the blood of breastfed infants [ Time Frame: Until the infant becomes 180 days of age. ]
    Characterize the pharmacokinetics and safety profile of understudied drugs administered per standard of care to lactating women and thus their breastfed infants as prescribed by their healthcare provider.


Secondary Outcome Measures :
  1. Safety profile of commonly used drugs in infants exposed to drugs in breastmilk [ Time Frame: Up to 27 months ]
    see Cohort 1-31 for listing of drugs


Biospecimen Retention:   Samples With DNA
Leftover specimens will be sent to NICHD repository for unknown future use


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511118


Contacts
Layout table for location contacts
Contact: Emily Forgey 919-660-8720 emily.forgey@duke.edu
Contact: Cheryl Alderman 919-966-8349 cheryl.alderman@duke.edu

Locations
Show Show 18 study locations
Sponsors and Collaborators
Duke University
The Emmes Company, LLC
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Layout table for investigator information
Principal Investigator: Kanecia Zimmerman, MD Duke University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Kanecia Obie Zimmerman, Associate Professor of Pediatrics, Duke University
ClinicalTrials.gov Identifier: NCT03511118    
Other Study ID Numbers: Pro00088919
HHSN275201000003I/27500051 ( Other Grant/Funding Number: NICHD )
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: June 9, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Remdesivir
Metformin
Topiramate
Azithromycin
Doxycycline
Ciprofloxacin
Levofloxacin
Clindamycin
Valganciclovir
Hydroxyurea
Interleukin 1 Receptor Antagonist Protein
Verapamil
Hydrochlorothiazide
Labetalol
Nifedipine
Furosemide
Sumatriptan
Oxycodone
Gabapentin
Ondansetron
Trazodone
Fluvoxamine
Cyclobenzaprine
Methylphenidate
Citalopram
Sertraline
Venlafaxine Hydrochloride
Tranexamic Acid
Rosuvastatin Calcium
Hypoglycemic Agents