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

Last updated: December 12, 2024
Sponsor: Duke University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

oxycodone

Sumatriptan

metformin

Clinical Study ID

NCT03511118
Pro00088919
HHSN275201000003I/27500051
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Lactating women who are receiving at least one DOI per SOC who are ≤180 dayspostpartum, and their infants (≤180 days of age) who receive maternal breastmilk.

  • Informed consent/HIPAA obtained, according to local IRB/REB/IEC guidelines, prior toany study-related procedures. Lactating women who are not legal adults and theirbreastfed infants may be enrolled if they assent to participate in the study andconsent is obtained from their legal guardian according to local IRB/REB/IECguidelines.

Exclusion

Exclusion Criteria:

  • Any concomitant condition which, in the opinion of the physicians providing patientcare or the principal investigator conducting the study, would preclude a subject'sparticipation in the study.

  • Known pregnancy during PK sampling.

Study Design

Total Participants: 1600
Treatment Group(s): 76
Primary Treatment: oxycodone
Phase:
Study Start date:
October 04, 2018
Estimated Completion Date:
July 31, 2027

Study 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.

Connect with a study center

  • BC Women's Hospital + Health Centre

    Vancouver, British Columbia V6H 3N1
    Canada

    Site Not Available

  • Lawson Health Research Institute

    London, Ontario N6A 5W9
    Canada

    Completed

  • The Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • Centre Hospitalier Universitaire Sainte-Justine

    Montréal, Quebec H3T IC5
    Canada

    Completed

  • University of California-San Diego Medical Center

    La Jolla, California 92093
    United States

    Active - Recruiting

  • Loma Linda University Health

    Loma Linda, California 92354
    United States

    Active - Recruiting

  • Ann and Robert H. Lurie Childrens Hospital of Chicago

    Chicago, Illinois 60614
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Completed

  • Indiana University Health

    Indianapolis, Indiana 46202
    United States

    Completed

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Children's Hospital and Clinics - Minneapolis

    Minneapolis, Minnesota 55404
    United States

    Active - Recruiting

  • University of New Mexico, Health Sciences Center

    Albuquerque, New Mexico 87131
    United States

    Completed

  • University of North Carolina Hospital

    Chapel Hill, North Carolina 27599
    United States

    Completed

  • Duke University Maternal and Fetal Medicine

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Hospital of the University of Pennsylvania Department of Maternal Fetal Medicine

    Philadelphia, Pennsylvania 19104
    United States

    Completed

  • University of Pittsburgh School of Medicine

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Texas Tech University Health Sciences Center School of Medicine.

    Amarillo, Texas 79106
    United States

    Active - Recruiting

  • University of Texas Medical Branch - Galveston

    Galveston, Texas 77555
    United States

    Active - Recruiting

  • The Women's Hospital of Texas

    Houston, Texas 77054
    United States

    Site Not Available

  • University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Texas Health Science Center

    San Antonio, Texas 78229
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Active - Recruiting

  • University of Washington

    Seattle, Washington 98195-7630
    United States

    Completed

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