Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care



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Therapuetic Areas:Cardiology / Vascular Diseases, Dermatology / Plastic Surgery, Endocrinology, Gastroenterology, Hematology, Immunology / Infectious Diseases, Musculoskeletal, Nephrology / Urology, Neurology, Ophthalmology, Otolaryngology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:Any - 21
Updated:4/6/2019
Start Date:November 2011
End Date:February 2020
Contact:Barrie Harper, MT (ASCP), PMP
Email:barrie.harper@duke.edu
Phone:919-668-8291

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Understudied drugs will be administered to children per standard of care as prescribed by
their treating caregiver and only biological sample collection during the time of drug
administration will be involved. A total of approximately 7000 children aged <21 years who
are receiving these drugs for standard of care will be enrolled and will be followed for up a
maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of
understudied drugs for which specific dosing recommendations and safety data are lacking. The
prescribing of drugs to children will not be part of this protocol. Taking advantage of
procedures done as part of routine medical care (i.e. blood draws) this study will serve as a
tool to better understand drug exposure in children receiving these drugs per standard of
care. The data collected through this initiative will also provide valuable pharmacokinetic
and dosing information of drugs in different pediatric age groups as well as special
pediatric populations (i.e. obese).

The purpose of this study is to characterize the PK ( Pharmacokinetics) of understudied drugs
administered to children per standard of care as prescribed by their treating caregiver. This
will be accomplished by the collection of biological samples during the time of drug
administration per standard of care as prescribed by the caregiver. The prescribing of drugs
to children will not be part of this protocol.

Aim #1: Evaluate the PK of understudied drugs currently being administered to children.

Hypothesis #1: The PK of understudied drugs in children will differ from adults and within
children according to pediatric age groups or special population.

Aim #2: Explore the pharmacodynamics (PD) of understudied drugs currently being administered
to children.

Hypothesis #2: The PD of targeted drugs in children will differ from adults.

Aim #3: Evaluate the influence of genetic factors, metabolic and protein profiles on
therapeutic exposure.

Hypothesis #3: Genetic polymorphisms in drug metabolizing enzymes and metabolic and proteomic
profiles will impact drug exposure in children.

Inclusion Criteria:

- 1) Children (< 21 years of age) who are receiving understudied drugs of interest per
standard of care as prescribed by their treating caregiver

Exclusion Criteria:

- 1) Failure to obtain consent/assent (as indicated)

- 2) Known pregnancy as determined via interview or testing if available.
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Principal Investigator: Mobeen Rathore, MD
Phone: 904-244-2266
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
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11100 Euclid Avenue
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(216) 844-1000
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Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Jospeh Majure
Phone: 601-815-4517
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Amira Al-Uzri, MD
Phone: 503-418-8112
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Margaret Scheffler
Phone: 401-444-2884
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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1600 Rockland Road
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Phone: 302-651-7521
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Anchorage, Alaska
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13123 E 16th Ave
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Chapel Hill, North Carolina 27599
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Phone: 984-974-7865
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171 Ashley Avenue
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843-792-1414
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Phone: 843-792-5309
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Charlottesville, Virginia 22908
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Chicago, Illinois 60614
Principal Investigator: William Muller, MD
Phone: 312-227-6285
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Cleveland, Ohio 44313
Principal Investigator: Martha Blackford, PharmD
Phone: 330-543-0731
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Columbia, South Carolina 29208
Principal Investigator: Lisa Knight
Phone: 803-434-4986
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3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
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Durham, North Carolina 27710
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Principal Investigator: Pahud Barbara, MD
Phone: 816-960-3007
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1319 Punahou Street
Honolulu, Hawaii 96826
Principal Investigator: Annette Amiotte
Phone: 808-369-1247
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Indianapolis, Indiana 46202
Principal Investigator: Gregory Sokol, MD,
Phone: 317-274-4708
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Kansas City, Kansas 66160
Principal Investigator: Pahud Barbara, MD
Phone: 816-960-3007
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Kansas City, Missouri 64108
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La Jolla, California 92093
Principal Investigator: Adriana Tremoulet, MD
Phone: 858-246-0012
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1 Medical Center Dr
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 (603) 650-5000
Principal Investigator: Paul Palumbo
Phone: 603-653-9064
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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1 Children's Way
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(501) 364-1100
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8701 W Watertown Plank Rd
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Morgantown, West Virginia
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Nashville, Tennessee 37232
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New Haven, Connecticut 06511
Principal Investigator: Matthew Bizzarro, MD
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New Orleans, Louisiana 70112
Principal Investigator: Stacy Drury
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Principal Investigator: Amanda England, MD
Phone: 504-894-2861
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New York, New York 10029
Principal Investigator: George Ofori-Amanfo, MD
Phone: 212-241-6489
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Oklahoma City, Oklahoma 73104
Principal Investigator: Christine Allen, MD
Phone: 405-271-4407
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Emile St
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Phone: 011-02-9845-0364
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Principal Investigator: Catherine Sherwin, MD
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