Clinical trial

Drugs in Breast Milk

Name

1000062184

Description

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.

Trial arms

Trial start

2022-03-09

Estimated PCD

2023-12-23

Trial end

2024-03-31

Status

Completed

Treatment

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.

Arms:

Breastfeeding women

Other names:

Typical brand names include, but not limited to: Tenoretic, Wellbutrin, Zyban, Briviact, Cipralex, Lexapro, Diflucan, Vimpat, Lamictal, Keppra, Trexall, Xatmep, Ezetrol, Nexlizet

Size

Primary endpoint

concentrations of target drugs in breast milk

an average of 1 year

Eligibility criteria

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'CROSS_SECTIONAL'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'breast milk samples, optional DNA samples'}, 'enrollmentInfo': {'count': 39, 'type': 'ACTUAL'}}

Updated at

2024-04-10

1 organization

1 product

1 indication

Organization

The Hospital for Sick Children

Product

Atenolol

Indication

Breastfeeding