Actively Recruiting
Postpartum Activity and Expression of BCRP and OCT1 Drug Transporters in the Mammary Gland
Led by University of Washington · Updated on 2024-08-06
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how the drug transporters OCT1 and BCRP work and are expressed in the breast tissue of healthy lactating women at three different times after giving birth. This phase I study aims to understand how drugs like cimetidine move through breast milk and how these transporters may affect this process. The study collects data at early, middle, and later postpartum periods to observe changes over time. Each participant will take a single oral dose of 200 mg cimetidine on three separate study days: between 3 to 5 weeks, 3 to 4 months, and 6 to 8 months after delivery. Blood, urine, and breast milk samples will be collected over 12 hours following each dose. The study will measure cimetidine levels using specialized lab tests, and breast milk cells will be analyzed to quantify OCT1 and BCRP transporter expression. Each woman acts as her own control to compare results across time points. Participants will provide samples during each study visit, including blood, urine, and breast milk, to assess drug concentrations and transporter activity. Genetic testing will be done to understand individual differences in drug transporter genes. Researchers will monitor how well the breast clears cimetidine and how these transporters are expressed at the cellular level across the postpartum period. The study will help clarify drug safety and behavior in lactating women, with a total participation spanning up to eight months postpartum.
CONDITIONS
Brief Title
Drug Excretion in Breast Milk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy postpartum women
- 18-50 years of age
- Able to provide written informed consent
You will not qualify if you...
- Taking cimetidine within 3 days prior to study days
- Allergic to cimetidine
- Taking medications that interact with cimetidine or affect OCT1, BCRP, or certain liver enzymes
- Taking BCRP or OCT1 inhibitors or inducers
- Known kidney disease with impaired renal function (serum creatinine > 1.2 mg/dL)
- Known significant liver disease (ALT > 2 times upper normal limit)
- Unable to fast for 4 hours before study visits
- Current smoker of tobacco or nicotine products
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 6 months postpartum (3 study days between 3-5 weeks and 6-8 months postpartum)
Participants receive a single oral dose of cimetidine 200 mg on each of 3 study days at 3-5 weeks, 3-4 months, and 6-8 months postpartum. Blood, urine, and breast milk samples are collected over 12 hours following each dose to measure drug concentrations and transporter expression.
3 study days with serial sample collections over 12 hours each day
Trial Site Locations
Total: 1 location
1
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
M
Mary Hebert, PharmD, FCCP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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