Drug Concentrations in Breast Milk and Prediction of Blood Levels of the Breastfed Infants

April 9, 2024 updated by: Shinya Ito, The Hospital for Sick Children

Drugs in Breast Milk

There is a significant lack of information on drug secretion into milk and infant exposure. As a first step to address this issue, the investigators examine milk concentrations of selected drugs prescribed to breastfeeding women, which lack milk excretion data. Milk data will be analyzed using population pharmacokinetic approaches, when possible, and acquired data of drug concentration profiles in milk will be combined with infant physiologically-based pharmacokinetic (PBPK) models to predict infant exposure levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study the investigators measure drug concentrations in breast milk (and optional blood) samples collected through sparse and flexible sampling strategy mitigating intense approaches of conventional PK study. Whenever possible, population PK method is used to characterize milk concentration profiles of the selected drugs. The obtained data is further processed through a PBPK model of infant to predict infant drug exposure levels.

The study also includes an optional pharmacogenetic part. This will allow the investigators to understand how variations in genetic composition plays role in breaking down drugs and how it affects the drug transfer into breast milk.

This study is conducted at three sites: Hospital for Sick Children (leading site), CHU Sainte Justine Hospital, Montreal (Study Lab: for drug measurement), and University of Waterloo (Modelling Core: to create computer model).

Study Type

Observational

Enrollment (Actual)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Mehzabin Rahman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Lactating women over the age of 18 who are taking one of the study medications at steady state. Potential participants (breastfeeding women) will be identified by the clinics of collaborators and if interested in participation their verbal consent will be obtained to share their contact information with the study team. Participation of breastfed infants of the mother is optional.

Description

Inclusion Criteria for breastfeeding women

  • Age of 18 years or older
  • Lactating women taking at least one of the study target drugs per Standard of Care
  • Obtained informed consent
  • Ability to communicate in English

Exclusion Criteria for breastfeeding women

  • Any concomitant medication
  • Known pregnancy during PK sampling

Inclusion criteria for their infant

  • Older than 1 week
  • Healthy

Exclusion criteria for their infant

  • Concomitant medical treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breastfeeding women
Either of the following drugs at steady state (Atenolol, Bupropion, Brivaracetam, Escitalopram, Fluconazole, Lacosamide, Lamotrigine, Levetiracetam, Methotrexate or Ezetimibe).
Drug: either of Atenolol, Bupropion, Brivaracetam, Escitalopram, Fluconazole, Lacosamide, Lamotrigine, Levetiracetam, Methotrexate or Ezetimibe
This is a cohort study of pharmacokinetics of drugs in milk. Participants in the group are those breastfeeding women on the listed drugs at steady state, who are prescribed these drugs for clinical reasons outside this study framework.
Other Names:
  • Typical brand names include, but not limited to: Tenoretic, Wellbutrin, Zyban, Briviact, Cipralex, Lexapro, Diflucan, Vimpat, Lamictal, Keppra, Trexall, Xatmep, Ezetrol, Nexlizet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
concentrations of target drugs in breast milk
Time Frame: an average of 1 year
using assays of drug concentrations validated in human milk as a matrix
an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Collaborators

St. Justine's Hospital
University of Waterloo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2022

Primary Completion (Actual)

December 23, 2023

Study Completion (Actual)

March 31, 2024

Study Registration Dates

First Submitted

September 13, 2022

First Submitted That Met QC Criteria

September 15, 2022

First Posted (Actual)

September 16, 2022

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000062184

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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