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| Name | Class |
|---|---|
| St. Justine's Hospital | OTHER |
| University of Waterloo | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breastfeeding women | Either of the following drugs at steady state (Atenolol, Bupropion, Brivaracetam, Escitalopram, Fluconazole, Lacosamide, Lamotrigine, Levetiracetam, Methotrexate or Ezetimibe). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| either of Atenolol, Bupropion, Brivaracetam, Escitalopram, Fluconazole, Lacosamide, Lamotrigine, Levetiracetam, Methotrexate or Ezetimibe | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| concentrations of target drugs in breast milk | using assays of drug concentrations validated in human milk as a matrix | an average of 1 year |
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Inclusion Criteria for breastfeeding women
Exclusion Criteria for breastfeeding women
Inclusion criteria for their infant
Exclusion criteria for their infant
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Lactating women over the age of 18 who are taking one of the study medications at steady state. Potential participants (breastfeeding women) will be identified by the clinics of collaborators and if interested in participation their verbal consent will be obtained to share their contact information with the study team. Participation of breastfed infants of the mother is optional.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mehzabin Rahman | Toronto | Ontario | M5G 1X8 | Canada |
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breast milk samples, optional DNA samples
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|
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D016642 | Bupropion |
| C482793 | brivaracetam |
| D000089983 | Escitalopram |
| D015725 | Fluconazole |
| D000078334 | Lacosamide |
| D000077213 | Lamotrigine |
| D000077287 | Levetiracetam |
| D008727 | Methotrexate |
| D000069438 | Ezetimibe |
| D003909 | Dexetimide |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D011437 | Propylamines |
| D000588 | Amines |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D000081 | Acetamides |
| D000577 | Amides |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D014227 | Triazines |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D001384 | Azetidines |
| D001385 | Azetines |
| D010881 | Piperidones |
| D010880 | Piperidines |
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