Drug Excretion in Breast Milk

Phase 4

Recruiting

• Conditions: OCT1; Lactation; BCRP; Drugs in Breast Milk; Postpartum; Mammary Drug Transporters
• Interventions: Drug: Cimetidine 200 MG

• Registration Number: NCT06056583
• Lead Sponsor: University of Washington

Brief 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.

Study Timeline

• Study First Submitted: 2023-09-14
• Study First Submitted QC: 2023-09-20
• Study First Posted: 2023-09-28
• Study Start: 2023-12-04
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-06
• Primary Completion: 2028-09-30
• Study Completion: 2028-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Healthy Lactating Women	Cimetidine 200 MG	Healthy Lactating Women will be studied on 3 study days and serve as their own control.

Primary Outcome Measures

Name	Time	Method
Mammary epithelial cell expression of BCRP	3-5 weeks, 3-4 months and 6-8 months postpartum	BCRP protein expression in MECs at three postpartum stages
Mammary clearance of cimetidine	3-5 weeks, 3-4 months and 6-8 months postpartum	Cimetidine excretion into breast milk at three postpartum stages
Mammary epithelial cell expression of OCT1	3-5 weeks, 3-4 months and 6-8 months postpartum	OCT1 protein expression in MECs at three postpartum stages

Secondary Outcome Measures

Name	Time	Method
Cimetidine relative infant dose and infant concentration	3-5 weeks, 3-4 months and 6-8 months postpartum	cimetidine relative infant dose (RID) and infant concentration
Maternal cimetidine PK	3-5 weeks, 3-4 months and 6-8 months postpartum	Effects of time postpartum on cimetidine elimination rate constant
Relationship between BCRP expression and activity	3-5 weeks, 3-4 months and 6-8 months postpartum	Effect of time postpartum on BCRP protein expression in MECs and correlation with cimetidine mammary CL
Relationship between OCT1 expression and activity	3-5 weeks, 3-4 months and 6-8 months postpartum	Effect of time postpartum on OCT1 protein expression in MECs and correlation with cimetidine mammary CL

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States