Actively Recruiting

Phase 4
Age: 14Days - 50Years
All Genders
Healthy Volunteers
NCT06056583

Drug Excretion in Breast Milk

Led by University of Washington · Updated on 2024-08-06

50

Participants Needed

1

Research Sites

251 weeks

Total Duration

On this page

Sponsors

U

University of Washington

Lead Sponsor

E

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Drug Excretion in Breast Milk

Who Can Participate

Age: 14Days - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy postpartum women
  • Aged 18 to 50 years
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Received cimetidine within 3 days before each study day
  • Known allergy or hypersensitivity to cimetidine
  • Taking medications that interact with cimetidine or affect OCT1, BCRP, or key liver enzymes
  • Taking BCRP or OCT1 inhibitors or inducers
  • Known kidney disease with impaired renal function (serum creatinine > 1.2 mg/dL)
  • Known significant liver disease (ALT more than 2 times upper limit of normal)
  • Unable to fast for 4 hours before each study day
  • Tobacco or nicotine product use

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University of Washington

Seattle, Washington, United States, 98195

Actively Recruiting

Loading map...

Research Team

M

Mary Hebert, PharmD, FCCP

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here