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

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ClinicalTrials.gov Identifier: NCT03511118
Recruitment Status : Recruiting
First Posted : April 27, 2018
Last Update Posted : October 10, 2018
Sponsor:
Collaborators:
The EMMES Corporation
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Kevin Watt, 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

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
Estimated Enrollment : 500 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 22, 2019
Estimated Study Completion Date : September 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

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.




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 1-10 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.


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
Contact: Leigh Gosnell +1 919 668-1280 leigh.gosnell@duke.edu
Contact: Gary Furda gary.furda@duke.edu

Locations
United States, North Carolina
Duke University Maternal and Fetal Medicine Recruiting
Durham, North Carolina, United States, 27705
Contact: Kristin Weaver    919-613-9630    obresearch@duke.edu   
Principal Investigator: Brenna Hughes, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195-7630
Contact: Maggie Leahy    540-525-0121    maleahy@u.washington.edu   
Principal Investigator: Mary Hébert, Pharm.D         
Sponsors and Collaborators
Kevin Watt
The EMMES Corporation
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Study Chair: Kevin Watt, MD,PhD Duke University

Responsible Party: Kevin Watt, Associate Professor of Pediatrics, Duke University
ClinicalTrials.gov Identifier: NCT03511118     History of Changes
Other Study ID Numbers: Pro00088919
HHSN275201000003I/27500051 ( Other Grant/Funding Number: NICHD )
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Metformin
Tranexamic Acid
Oxycodone
Ondansetron
Dexetimide
Labetalol
Citalopram
Sertraline
Nifedipine
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Neurotransmitter Agents
Serotonin Agents