Drug Excretion in Breast Milk

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT06056583
Phase
PHASE4
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
14 Days - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Cimetidine 200 MG — DRUG
    Cimetidine will serve as the probe drug

Study Details

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.

Key Dates

Start date
Dec 4, 2023
Status verified
Aug 2024
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Other: Healthy Lactating Women
    Healthy Lactating Women will be studied on 3 study days and serve as their own control.

Primary Outcome Measure

Mammary clearance of cimetidine [ Time Frame: 3-5 weeks, 3-4 months and 6-8 months postpartum ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WashingtonSeattleWashington98195
Mary F Hebert, PharmD
[email protected]
206-616-5016

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By research site
University of Washington· Seattle, WA

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