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

Sponsor

The Hospital for Sick Children (Other)

Overall Status

Recruiting

CT.gov ID

NCT05543122

Collaborator

St. Justine's Hospital (Other), University of Waterloo (Other)

304

Enrollment

Location

24.5

Anticipated Duration (Months)

12.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Feeding	Drug: either of Atenolol, Bupropion, Brivaracetam, Escitalopram, Fluconazole, Lacosamide, Lamotrigine, Levetiracetam, Methotrexate or Ezetimibe

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 Design

Study Type:

Observational

Anticipated Enrollment :

304 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Drugs in Breast Milk

Actual Study Start Date :

Mar 9, 2022

Anticipated Primary Completion Date :

Dec 23, 2023

Anticipated Study Completion Date :

Mar 23, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

concentrations of target drugs in breast milk [an average of 1 year]
using assays of drug concentrations validated in human milk as a matrix

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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