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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Tranexamic acid (TXA) — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• labetalol — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• metformin — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• nifedipine — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• clindamycin — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• oxycodone — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• azithromycin — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• escitalopram — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• sertraline — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• ondansetron — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Ciprofloxacin — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Doxycycline — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Levofloxacin — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Methylphenidate — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Sumatriptan — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Citalopram — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Cyclobenzaprine — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Furosemide — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Gabapentin — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Hydrochlorothiazide — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Hydroxyurea — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Rosuvastatin — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Topiramate — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Trazodone — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Valganciclovir — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Venlafaxine — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Verapamil — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Remdesivir — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Anakinra — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Tocilizumab — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Fluvoxamine — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Amoxicillin — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Bupropion — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Duloxetine — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Hydrocodone — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Levetiracetam — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Paroxetine — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
• Buprenorphine — DRUG
  Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

Study Details

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.

Key Dates

Start date

Oct 4, 2018

Status verified

Apr 2026

Primary completion

Jul 23, 2027

Completion

Jul 31, 2028

Study Design

Enrollment

1,600 participants (estimated)

Arms

• Arm: Tranexamic acid (TXA)
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: labetalol
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: metformin
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: nifedipine
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: clindamycin
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: oxycodone
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: azithromycin
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: escitalopram
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: sertraline
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: ondansetron
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Ciprofloxacin
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Doxycycline
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Levofloxacin
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Methylphenidate
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Sumatriptan
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Citalopram
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Cyclobenzaprine
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Furosemide
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Gabapentin
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Hydrochlorothiazide
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Hydroxyurea
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Rosuvastatin
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Topiramate
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Trazodone
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Valganciclovir
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Venlafaxine
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Verapamil
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Remdesivir
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Anakinra
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Tocilizumab
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Fluvoxamine
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Amoxicillin
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Bupropion
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Buprenorphine
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Hydrocodone
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Levetiracetam
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Paroxetine
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.
• Arm: Duloxetine
  No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Primary Outcome Measure

M/P ratio [ Time Frame: Until the infant becomes 180 days of age ]

Central Contacts

• Emily Forgey
  919-660-8720
  [email protected]
• Cheryl Alderman
  919-966-8349
  [email protected]

Locations (20)

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