Clinical trial NCT03511118: Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
Official title: Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lactating Women on Select DOI
Breastfed Infants of Mothers on Select DOI
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: The Emmes Company, LLC
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-04-27
Enrollment: 1600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lactating women receiving DOIs per SOC, as prescribed by their healthcare providers, and their breastfed infants.

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.

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.

Eligibility 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.

Primary outcomes:
measure: M/P ratio
timeFrame: Until the infant becomes 180 days of age
measure: DID
timeFrame: Until the infant becomes 180 days of age
measure: RID
timeFrame: Until the infant becomes 180 days of age
measure: I/M ratio
timeFrame: Until the infant becomes 180 days of age
Secondary outcomes:
measure: Safety profile of commonly used drugs in infants exposed to drugs in breastmilk
timeFrame: Until the infant becomes 180 days of age
measure: AE
timeFrame: Up until 180 days of age
measure: SAE
timeFrame: Up until 180 days of age
measure: ESI
timeFrame: Until the infant becomes 180 days of age
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California-San Diego Medical Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Health
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Ann and Robert H. Lurie Childrens Hospital of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Minneapolis
country: United States
facility: Children's Hospital and Clinics - Minneapolis
state: Minnesota
city: Albuquerque
country: United States
facility: University of New Mexico, Health Sciences Center
state: New Mexico
city: Chapel Hill
country: United States
facility: University of North Carolina Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Maternal and Fetal Medicine
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania Department of Maternal Fetal Medicine
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine
state: Pennsylvania
city: Amarillo
country: United States
facility: Texas Tech University Health Sciences Center School of Medicine.
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch - Galveston
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Houston
country: United States
facility: The Women's Hospital of Texas
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: London
country: Canada
facility: Lawson Health Research Institute
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier Universitaire Sainte-Justine
state: Quebec
Study officials:
affiliation: Duke University
name: Kanecia Zimmerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.