Drug Excretion in Breast Milk

Status Recruiting

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

Lactation

Clinical Trial Details

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

View Details

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