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

NCT03511118 | Recruiting DMC FDA Drug

• 2 other identifiers: Pro00088919HHSN275201000003I/27500051
• Study Type: observational
• Target: 1,600
• Locations: 2 countries
• Sites: 22

Brief 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

Outcome Measures

Primary Outcomes (4)

• M/P ratio

  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.

  Until the infant becomes 180 days of age

• DID

  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.

  Until the infant becomes 180 days of age

• RID

  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.

  Until the infant becomes 180 days of age

• I/M ratio

  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.

  Until the infant becomes 180 days of age

Secondary Outcomes (4)

• Safety profile of commonly used drugs in infants exposed to drugs in breastmilk

  Until the infant becomes 180 days of age

• AE

  Up until 180 days of age

• SAE

  Up until 180 days of age

• ESI

  Until the infant becomes 180 days of age

Study Arms (38)

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.

Drug: Tranexamic acid (TXA)

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.

Drug: labetalol

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.

Drug: metformin

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.

Drug: nifedipine

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.

Drug: clindamycin

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.

Drug: oxycodone

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.

Drug: azithromycin

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.

Drug: escitalopram

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.

Drug: sertraline

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.

Drug: ondansetron

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.

Drug: Ciprofloxacin

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.

Drug: Doxycycline

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.

Drug: Levofloxacin

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.

Drug: Methylphenidate

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.

Drug: Sumatriptan

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.

Drug: Citalopram

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.

Drug: Cyclobenzaprine

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.

Drug: Furosemide

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.

Drug: Gabapentin

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.

Drug: Hydrochlorothiazide

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.

Drug: Hydroxyurea

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.

Drug: Rosuvastatin

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.

Drug: Topiramate

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.

Drug: Trazodone

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.

Drug: Valganciclovir

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.

Drug: Venlafaxine

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.

Drug: Verapamil

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.

Drug: Remdesivir

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.

Drug: Anakinra

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.

Drug: Tocilizumab

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.

Drug: Fluvoxamine

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.

Drug: Amoxicillin

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.

Drug: Bupropion

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.

Drug: Buprenorphine

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.

Drug: Hydrocodone

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.

Drug: Levetiracetam

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.

Drug: Paroxetine

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.

Drug: Duloxetine

Interventions

Tranexamic acid (TXA) DRUG

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

Tranexamic acid (TXA)

labetalol DRUG

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

labetalol

metformin DRUG

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

metformin

nifedipine DRUG

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

nifedipine

clindamycin DRUG

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

clindamycin

oxycodone DRUG

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

oxycodone

azithromycin DRUG

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

azithromycin

escitalopram DRUG

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

escitalopram

sertraline DRUG

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

sertraline

ondansetron DRUG

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

ondansetron

Ciprofloxacin DRUG

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

Ciprofloxacin

Doxycycline DRUG

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

Doxycycline

Levofloxacin DRUG

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

Levofloxacin

Methylphenidate DRUG

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

Methylphenidate

Sumatriptan DRUG

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

Sumatriptan

Citalopram DRUG

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

Citalopram

Cyclobenzaprine DRUG

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

Cyclobenzaprine

Furosemide DRUG

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

Furosemide

Gabapentin DRUG

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

Gabapentin

Hydrochlorothiazide DRUG

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

Hydrochlorothiazide

Hydroxyurea DRUG

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

Hydroxyurea

Rosuvastatin DRUG

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

Rosuvastatin

Topiramate DRUG

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

Topiramate

Trazodone DRUG

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

Trazodone

Valganciclovir DRUG

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

Valganciclovir

Venlafaxine DRUG

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

Venlafaxine

Verapamil DRUG

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

Verapamil

Remdesivir DRUG

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

Remdesivir

Anakinra DRUG

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

Anakinra

Tocilizumab DRUG

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

Tocilizumab

Fluvoxamine DRUG

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

Fluvoxamine

Amoxicillin DRUG

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

Amoxicillin

Bupropion DRUG

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

Bupropion

Duloxetine DRUG

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

Duloxetine

Hydrocodone DRUG

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

Hydrocodone

Levetiracetam DRUG

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

Levetiracetam

Paroxetine DRUG

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

Paroxetine

Buprenorphine DRUG

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

Buprenorphine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Lactating women receiving DOIs per SOC, as prescribed by their healthcare providers, and their breastfed infants.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• The Emmes Company, LLC: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (22)

University of California-San Diego Medical Center

La Jolla, California, 92093, United States

RECRUITING

Loma Linda University Health

Loma Linda, California, 92354, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

COMPLETED

Ann and Robert H. Lurie Childrens Hospital of Chicago

Chicago, Illinois, 60614, United States

RECRUITING

Indiana University Health

Indianapolis, Indiana, 46202, United States

COMPLETED

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

ACTIVE NOT RECRUITING

Children's Hospital and Clinics - Minneapolis

Minneapolis, Minnesota, 55404, United States

RECRUITING

University of New Mexico, Health Sciences Center

Albuquerque, New Mexico, 87131, United States

COMPLETED

University of North Carolina Hospital

Chapel Hill, North Carolina, 27599, United States

COMPLETED

Duke University Maternal and Fetal Medicine

Durham, North Carolina, 27705, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

Hospital of the University of Pennsylvania Department of Maternal Fetal Medicine

Philadelphia, Pennsylvania, 19104, United States

COMPLETED

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Texas Tech University Health Sciences Center School of Medicine.

Amarillo, Texas, 79106, United States

RECRUITING

University of Texas Medical Branch - Galveston

Galveston, Texas, 77555, United States

RECRUITING

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

The Women's Hospital of Texas

Houston, Texas, 77054, United States

RECRUITING

University of Texas Health Science Center

San Antonio, Texas, 78229, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84132, United States

RECRUITING

University of Washington

Seattle, Washington, 98195-7630, United States

COMPLETED

Lawson Health Research Institute

London, Ontario, N6A 5W9, Canada

COMPLETED

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, H3T IC5, Canada

COMPLETED

Related Publications (1)

• Job KM, Dallmann A, Parry S, Saade G, Haas DM, Hughes B, Berens P, Chen JY, Fu C, Humphrey K, Hornik C, Balevic S, Zimmerman K, Watt K. Development of a Generic Physiologically-Based Pharmacokinetic Model for Lactation and Prediction of Maternal and Infant Exposure to Ondansetron via Breast Milk. Clin Pharmacol Ther. 2022 May;111(5):1111-1120. doi: 10.1002/cpt.2530. Epub 2022 Mar 5.

  PMID: 35076931 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Leftover specimens will be sent to NICHD repository for unknown future use

MeSH Terms

Interventions

Tranexamic Acid; Labetalol; Metformin; Nifedipine; Clindamycin; Oxycodone; Azithromycin; Escitalopram; Sertraline; Ondansetron; Ciprofloxacin; Doxycycline; Levofloxacin; Methylphenidate; Sumatriptan; Citalopram; cyclobenzaprine; Furosemide; Gabapentin; Hydrochlorothiazide; Hydroxyurea; Rosuvastatin Calcium; Topiramate; Trazodone; Valganciclovir; Venlafaxine Hydrochloride; Verapamil; remdesivir; Interleukin 1 Receptor Antagonist Protein; tocilizumab; Fluvoxamine; Amoxicillin; Bupropion; Duloxetine Hydrochloride; Hydrocodone; Levetiracetam; Paroxetine; Buprenorphine

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Ethanolamines; Amino Alcohols; Alcohols; Salicylamides; Amides; Amines; Biguanides; Guanidines; Amidines; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Lincomycin; Lincosamides; Pyrrolidines; Glycosides; Carbohydrates; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Propylamines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; 1-Naphthylamine; Naphthalenes; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Tetracyclines; Naphthacenes; Ofloxacin; Phenylacetates; Piperidines; Sulfonamides; Sulfones; Sulfur Compounds; Tryptamines; Sulfanilamides; Aniline Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Chlorothiazide; Benzothiadiazines; Thiazides; Urea; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Pyrimidines; Fructose; Hexoses; Monosaccharides; Sugars; Ketoses; Piperazines; Pyridones; Ganciclovir; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Cyclohexanols; Hexanols; Fatty Alcohols; Phenethylamines; Ethylamines; Lipids; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Proteins; Biological Factors; Oximes; Hydroxylamines; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Propiophenones; Ketones; Thiophenes; Acetamides; Acetates; Pyrrolidinones

Study Officials

• Samia Aleem, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Forgey

CONTACT

919-660-8720; emily.forgey@duke.edu

Cheryl Alderman

CONTACT

919-966-8349; cheryl.alderman@duke.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: April 27, 2018
• Study Start: October 4, 2018
• Primary Completion (Estimated): July 23, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (20)