"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
|Condition or disease||Intervention/treatment|
|Lactation||Other: No intervention|
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.
- 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.
|Study Type :||Observational|
|Actual Enrollment :||68 participants|
|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|
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.
- 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
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
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G1X8|
|Principal Investigator:||Shinya Ito, MD, FRCPC||The Hospital for Sick Children|