Understanding Drug Excretion in Breast Milk

This study is looking at how the drug cimetidine (used to treat heartburn and ulcers) gets into breast milk. Researchers want to understand how certain proteins (OCT1 and BCRP) in the breast gland affect this process. You might be able to join if you are a healthy woman between 18 and 50 years old who has recently given birth and is breastfeeding. The study will measure how much cimetidine is in your breast milk at different times after you take it. This will help us understand how drugs are passed to infants through breast milk. The study plans to enroll 50 participants, but its current status is unclear.

Study design
This is an interventional study that is not randomized and does not specify a phase. It plans to enroll 50 participants.
What's involved
You will receive a single dose of cimetidine on three separate study days (3-5 weeks, 3-4 months, and 6-8 months postpartum). On each of these days, you will provide blood, urine, and breast milk samples over 12 hours.
Compensation
Not stated in the trial record.
Follow-up
You will be followed at 3-5 weeks, 3-4 months, and 6-8 months postpartum.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06056583

Drug Excretion in Breast Milk

Recruiting
PHASE4Ages 14–50InterventionalBasic science
University of Washington
~50 participants
Updated 2024-08-06 on ClinicalTrials.gov
What's tested:Cimetidine 200 MG

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mammary clearance of cimetidine
Measured over 3-5 weeks, 3-4 months and 6-8 months postpartum
+2 more outcomes measured
Postpartum
Lactation
Drugs in Breast Milk
Mammary Drug Transporters
BCRP
OCT1
1 sites across 1 states
Washington1
  • Mary Hebert, PharmD, FCCP · PRINCIPAL_INVESTIGATOR · University of Washington

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  • Mammary clearance of cimetidine3-5 weeks, 3-4 months and 6-8 months postpartum

    Cimetidine excretion into breast milk at three postpartum stages

  • Mammary epithelial cell expression of BCRP3-5 weeks, 3-4 months and 6-8 months postpartum

    BCRP protein expression in MECs at three postpartum stages

  • Mammary epithelial cell expression of OCT13-5 weeks, 3-4 months and 6-8 months postpartum

    OCT1 protein expression in MECs at three postpartum stages