Skip to main content
OpenTrials
Completed

NCT Number: NCT05543122

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Feeding Behavior Feeding Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Mehzabin Rahman

Toronto, Ontario, M5G 1X8, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

either of Atenolol, Bupropion, Brivaracetam, Escitalopram, Fluconazole, Lacosamide, Lamotrigine, Levetiracetam, Methotrexate or Ezetimibe

Drug

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • St. Justine's Hospital
  • University of Waterloo

Registry information

Official study title

Drugs in Breast Milk

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Sep 16, 2022
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.