Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Summary

Over half of women in the US who are breastfeeding their infants take prescription drugs. You are being asked to participate in this study because you are breastfeeding your infant and are currently taking, as part of your medical care, at least one of the drugs we are studying. We are interested in studying drugs commonly prescribed to women who are breastfeeding so we can learn more about the amount of drug that is transferred to breastmilk and estimate how much of drug that is consumed by breastfed infants.

Conditions

• Lactating Women on Select DOI
• Breastfed Infants of Mothers on Select DOI

Interventions

DRUG

Fluvoxamine

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Amoxicillin

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Bupropion

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Duloxetine

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Hydrocodone

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Levetiracetam

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Paroxetine

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Buprenorphine

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Tocilizumab

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Trazodone

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Valganciclovir

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Venlafaxine

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Verapamil

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Remdesivir

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Anakinra

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Tranexamic acid (TXA)

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

labetalol

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

metformin

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

nifedipine

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

clindamycin

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

oxycodone

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

azithromycin

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

escitalopram

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

sertraline

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

ondansetron

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Ciprofloxacin

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Doxycycline

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Levofloxacin

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Methylphenidate

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Sumatriptan

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Citalopram

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Cyclobenzaprine

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Furosemide

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Gabapentin

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Hydrochlorothiazide

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Hydroxyurea

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Rosuvastatin

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

DRUG

Topiramate

Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Sponsors & Collaborators

• The Emmes Company, LLC

  collaborator INDUSTRY

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

  collaborator NIH

• Duke University

  lead OTHER

Principal Investigators

• Samia Aleem, MD · Duke University

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-10-04

Primary Completion

2027-07-23

Completion

2028-07-31

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations