NCT06056583

Drug Excretion in Breast Milk

Postpartum Activity and Expression of BCRP and OCT1 Drug Transporters in the Mammary Gland

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 14 Days – 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Postpartum
• Lactation
• Drugs in Breast Milk
• Mammary Drug Transporters
• BCRP
• OCT1

Interventions

Type	Name	Description
DRUG	Cimetidine 200 MG	Cimetidine will serve as the probe drug

Timeline

• Start date: 2023-12-04
• Primary completion: 2028-09-30
• Completion: 2028-09-30
• First posted: 2023-09-28
• Last updated: 2024-08-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study