Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants (NCT03511118) — Mexico Trial Details

Condition(s) studied

Lactating Women on Select DOIBreastfed Infants of Mothers on Select DOI

Investigational drug(s) / intervention(s)

Tranexamic acid (TXA) →labetalol →metformin →nifedipine →clindamycin →oxycodone →azithromycin →escitalopram →sertraline →ondansetron →Ciprofloxacin →Doxycycline →Levofloxacin →Methylphenidate →Sumatriptan →Citalopram →Cyclobenzaprine →Furosemide →Gabapentin →Hydrochlorothiazide →Hydroxyurea →Rosuvastatin →Topiramate →Trazodone →Valganciclovir →Venlafaxine →Verapamil →Remdesivir →Anakinra →Tocilizumab →Fluvoxamine →Amoxicillin →Bupropion →Duloxetine →HydrocodoneLevetiracetam →Paroxetine →Buprenorphine →

Tranexamic acid (TXA): Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Study 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.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

No

Inclusion Criteria: * Lactating women who are receiving at least one DOI per SOC who are ≤180 days postpartum, and their infants (≤180 days of age) who receive maternal breastmilk. * Informed consent/HIPAA obtained, according to local IRB/REB/IEC guidelines, prior to any study-related procedures. Lactating women who are not legal adults and their breastfed infants may be enrolled if they assent to participate in the study and consent is obtained from their legal guardian according to local IRB/REB/IEC guidelines. Exclusion Criteria: * Any concomitant condition which, in the opinion of the physicians providing patient care or the principal investigator conducting the study, would preclude a subject's participation in the study. * Known pregnancy during PK sampling.

Primary outcome measure(s)

M/P ratio — Until the infant becomes 180 days of age
Characterize the pharmacokinetics using maternal milk/plasma exposure ratio is calculated by dividing the BMS01 drug of interest breastmilk concentration by the BMS01 drug of interest in maternal plasma concentration.
DID — Until the infant becomes 180 days of age
Pharmacokinetics is characterized by estimated daily infant dose-daily infant dose which estimates the quantity of drug delivered to an infant via breastmilk in a given day.
RID — Until the infant becomes 180 days of age
Pharmacokinetics is characterized by relative infant dose is a method of relating the potential dose of the drug delivered to the infant to the typical therapeutic dose given to the mother.
I/M ratio — Until the infant becomes 180 days of age
Pharmacokinetics is characterized using infant maternal/exposure ratio. IM ratio is calculated using the average infant plasma concentration of the BMS01 drug of interest and historical value of clearance in infants.

Trial sites (22)

Facility	City	Region	Status
University of California-San Diego Medical Center	La Jolla	California	Recruiting
Loma Linda University Health	Loma Linda	California	Recruiting
Northwestern University	Chicago	Illinois	Completed
Ann and Robert H. Lurie Childrens Hospital of Chicago	Chicago	Illinois	Recruiting
Indiana University Health	Indianapolis	Indiana	Completed
University of Iowa Hospitals and Clinics	Iowa City	Iowa	Active Not Recruiting
Children's Hospital and Clinics - Minneapolis	Minneapolis	Minnesota	Recruiting
University of New Mexico, Health Sciences Center	Albuquerque	New Mexico	Completed
University of North Carolina Hospital	Chapel Hill	North Carolina	Completed
Duke University Maternal and Fetal Medicine	Durham	North Carolina	Recruiting
Oregon Health & Science University	Portland	Oregon	Recruiting
Hospital of the University of Pennsylvania Department of Maternal Fetal Medicine	Philadelphia	Pennsylvania	Completed
University of Pittsburgh School of Medicine	Pittsburgh	Pennsylvania	Recruiting
Texas Tech University Health Sciences Center School of Medicine.	Amarillo	Texas	Recruiting
University of Texas Medical Branch - Galveston	Galveston	Texas	Recruiting
University of Texas Health Science Center at Houston	Houston	Texas	Recruiting
The Women's Hospital of Texas	Houston	Texas	Recruiting
University of Texas Health Science Center	San Antonio	Texas	Recruiting
University of Utah	Salt Lake City	Utah	Recruiting
University of Washington	Seattle	Washington	Completed
Lawson Health Research Institute	London	Ontario	Completed
Centre Hospitalier Universitaire Sainte-Justine	Montreal	Quebec	Completed

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