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

See also
Status	Clinical Trial	Phase
Completed	`NCT02542527` - Evaluation of the Functionality of a Fluid Filled Single Breast Pump	N/A
Terminated	`NCT02755194` - "Drugs in Lactation" Analysis Consortium
Terminated	`NCT00851591` - Effect of Fenugreek on Milk Production	N/A
Withdrawn	`NCT00181649` - Recombinant Human Prolactin for Lactation Induction	Phase 2
Completed	`NCT00181610` - Recombinant Human Prolactin for Lactation Induction	Phase 2
Completed	`NCT04024865` - Domperidone and Risk of Serious Cardiac Events in Postpartum Women
Terminated	`NCT02378233` - Iodine Status in Swedish Lactating Women - Effect of Iodine Supplementation in the Thyroid Function of Mother and Infant	N/A
Recruiting	`NCT06203444` - An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating Females	Phase 1
Completed	`NCT01747668` - Lactation Fortification Study	Phase 3
Completed	`NCT02621827` - Vitamin D Half-life in Pregnancy and Lactation	N/A
Completed	`NCT01463202` - Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression	Phase 4
Terminated	`NCT04146909` - The Effect of Lactation on Insulin Sensitivity and Lipolysis in Women	N/A
Completed	`NCT04593719` - Effect of Lactation Management Model on Breastfeeding Process	N/A
Completed	`NCT01548313` - The Role of Human Milk in Development of Breast Fed Child's Intestinal Microbiota
Completed	`NCT02690675` - Iron Supplement Effect on Child Development	N/A
Completed	`NCT05123183` - Nonpharmacological Methods and Lactation	N/A
Completed	`NCT03091985` - Influence of the Brownie Breast Shield on the Dynamics of Milk Removal	N/A
Completed	`NCT02190448` - Randomized, Placebo-Controlled Study of an Herbal Tea to Support Lactation	N/A
Not yet recruiting	`NCT06264349` - Women and Maternity: Development of a Nutritional Education Project	N/A
Recruiting	`NCT02384655` - Effect of Fenugreek Use in Mothers of Preterm on Breast Milk Production and Macronutrient Content	Phase 1/Phase 2