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"Drugs in Lactation" Analysis Consortium (DLAC)

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ClinicalTrials.gov Identifier: NCT02755194
Recruitment Status : Terminated (This infrastructure project has been taken over by another study.)
First Posted : April 28, 2016
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Shinya Ito, The Hospital for Sick Children

Brief Summary:
Some medications taken by the breastfeeding women are excreted into milk, posing a potential risk of toxicity to the infant. The first line of evidence required for toxicity risk assessment is prediction of drug levels in milk. However, pharmacokinetic (PK) information of drug excretion into milk is largely lacking, or limited to data from case reports. This makes it difficult to provide population-level prediction of drug levels in milk. The lack of data on this topic jeopardizes not only maternal adherence to drug therapy during breastfeeding but also establishment of breastfeeding, even if the drug is considered safe during nursing. Clearly, this clinical problem in drug safety is an important women's health issue, affecting both mother and infant. "Drugs in Lactation" Analysis Consortium (DLAC) is a "drug-in-milk" monitoring network, which is designed as a platform for efficient collection of patient milk samples in a real world setting to generate population predictions of drug excretion levels into human milk.

Condition or disease Intervention/treatment
Lactation Other: No intervention

Detailed Description:

OVERARCHING GOAL OF DLAC:

To establish a post-marketing "drug-in-milk" monitoring system for nursing women who are prescribed and using medications. Drugs in Lactation Analysis Consortium (DLAC) will provide risk assessment data and tools for toxicity detection in the form of population estimates and variations of drug levels in mother's milk and infant plasma for several common medications in a real world setting.

SPECIFIC OBJECTIVES:

  • To generate data on drug levels in breast milk
  • To develop a population pharmacokinetic model describing drug levels in milk
  • To simulate/predict drug levels in milk in a population, based on the pop PK model
  • To develop a physiologically-based pharmacokinetic (PBPK) model describing drug levels in infant serum
  • To screen the breastfed infants of mothers on the study drugs for general health condition (medical issues, developmental milestones)

SCOPE AND RATIONALE:

Information on the extent of drug excretion into mother's milk is lacking, mainly due to the following two reasons: 1) nursing women are excluded from drug trials; 2) ethical and practical difficulties in conducting intensive-sampling PK studies in the breastfeeding mothers. Even if data exist, they are based on small numbers of patients, and it is difficult to translate the information into population estimates of drug levels in milk. DLAC is developed as a novel drug safety network using population PK (popPK) modeling approach, which allows population-level PK parameter estimation, modeling and simulation based on a scheme of sparse sampling per individual, systematically collected from a large number of nursing women on medication in real world setting. This approach will provide population risk estimates as probability distribution of reaching certain drug level in milk and plasma. Equipped with a versatile drug analysis core and a popPK modeling and simulation unit, DLAC will be able to generate PK estimates of a population in the context of breastfeeding.

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Study Type : Observational
Actual Enrollment : 68 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: "Drugs in Lactation" Analysis Consortium (DLAC)
Actual Study Start Date : September 2014
Actual Primary Completion Date : September 25, 2019
Actual Study Completion Date : September 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Group/Cohort Intervention/treatment
Breastfeeding women on the study medications
The study population consists of lactating/breastfeeding women over the age of 18, who are able to communicate in English and are taking one or more of the study drugs (Infliximab, Adalimumab, Golimumab, Certolizumab, Etanercept, Methotrexate, Ezetimibe, Bupropion, Citalopram, Venlafaxine)
Other: No intervention
This is an observational study. The exposure of interest includes taking specific prescribed medications during breastfeeding.




Primary Outcome Measures :
  1. Drug levels in breast milk [ Time Frame: Through the study completion, an average of 4 years ]
    Robust parameter estimates from pop PK modelling usually require samples from >30-50 individuals. Therefore, an average of 4 years is considered as the time frame, so that the required numbers of samples for each drug can be collected for population PK analysis and modelling.


Biospecimen Retention:   Samples Without DNA
Breast milk samples are collected at different time-points before and after taking the medication.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Lactating women over the age of 18 who are taking one of the drugs of interest of the study
Criteria

Inclusion Criteria:

  • Age over 18 years old Taking one or more drugs of interest of the study, at steady state

Exclusion Criteria:

  • Being unable to communicate in English, Colostrum phase (<1 week postpartum)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02755194


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Shinya Ito, MD, FRCPC The Hospital for Sick Children
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Responsible Party: Shinya Ito, Division Head, Senior Scientist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02755194    
Other Study ID Numbers: 1000036538
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Shinya Ito, The Hospital for Sick Children:
pharmacokinetics
Drug-in-milk
breastfeeding
drug safety
population pharmacokinetics