Hydoxyurea Exposure in Lactation A Pharmacokinetics Study (HELPS) (HELPS)
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Hydroxyurea Concentration [ Time Frame: 31-Dec-2019 ]
Hydroxyurea concentration for each collected specimen will be analyzed and summarized.
Biospecimen Retention: Samples Without DNA
1. To obtain blood, urine, and breastmilk samples for pharmacokinetics calculations using a scheduled collection and analysis strategy. 2. To calculate distribution ratios for hydroxyurea across compartments, especially plasma to milk; and 3. To create population PK profiles for hydroxyurea to help calculate potential infant drug exposure
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 99 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy Controls and Women taking Hydroxyurea prescribed by treating physician and lactating
Lactating females, ≥ 18.0 years of age, at the time of enrollment
Willingness to limit the baby's exposure to hydroxyurea through breastmilk, such as healthy volunteers using the "pump and dump" technique or avoiding direct breastfeeding or collection of pumped milk for at least 8 hours after taking the hydroxyurea dose. This applies only to healthy controls or women with sickle cell who are not already taking hydroxyurea. Women with sickle cell already taking hydroxyurea may continue to breastfeed their infants.
Persons with known allergies to hydroxyurea
Failure to sign informed consent, or inability to undergo informed consent process
Persons for whom it is not feasible or medically advisable to obtain the specimens necessary for this study