- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02755194
"Drugs in Lactation" Analysis Consortium (DLAC)
"Drugs in Lactation" Analysis Consortium (DLAC)
Study Overview
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G1X8
- The Hospital for Sick Children
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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)
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This is an observational study.
The exposure of interest includes taking specific prescribed medications during breastfeeding.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Drug levels in breast milk
Time Frame: Through the study completion, an average of 4 years
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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.
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Through the study completion, an average of 4 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shinya Ito, MD, FRCPC, The Hospital for Sick Children
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1000036538
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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