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Clinical Trial Summary

This is a prospective, non-randomized, phase I study design evaluating the in vivo activities and expression of OCT1 and BCRP in mammary gland of lactating women at three time points postpartum.


Clinical Trial Description

Each woman will receive a single oral dose of cimetidine 200 mg on each of 3 study days (3-5 weeks, 3-4 months, and 6-8 months postpartum) followed by serial collection of blood, urine and breast milk samples over 12-hours. Cimetidine concentrations will be assay using a validated LC/MS/MS assay. Subjects will be genotyped for OCT1 and BCRP. Mammary epithelial cells will be isolated from breast milk and transporter expression will be quantified. Each woman will serve as her own control. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06056583
Study type Interventional
Source University of Washington
Contact Mary Hebert, PharmD, FCCP
Phone 206-616-5016
Email mhebert@uw.edu
Status Recruiting
Phase Phase 4
Start date December 4, 2023
Completion date September 30, 2028

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