Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)

ClinicalTrials.gov ID: NCT04278404

Public ClinicalTrials.gov record NCT04278404. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 1, 2026, 2:55 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

Study identification

NCT ID: NCT04278404
Recruitment status: Recruiting
Study type: Observational
Phase: Not listed
Lead sponsor: Duke University; Other
Enrollment: 5,000 participants

Eligibility (public fields only)

Age range: 0 Years to 20 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 4, 2020
Primary completion: Oct 31, 2026
Completion: Nov 30, 2026
Last update posted: Aug 20, 2026

2020 – 2026

United States locations

U.S. sites: 49
U.S. states: 35
U.S. cities: 43

Facility	City	State	ZIP	Site status
Phoenix Children's Hospital	Phoenix	Arizona	85016	Completed
Arkansas Children's Hospital Research Institute	Little Rock	Arkansas	72202	Completed
University of California, Los Angeles Medical Center	Los Angeles	California	90095	Completed
Lucile Packard Children's Hospital	Palo Alto	California	94304	Recruiting
Colorado University Denver	Aurora	Colorado	80045	Completed
The Children's Hospital Colorado	Aurora	Colorado	80045	Completed
Alfred I. DuPont Hospital for Children	Wilmington	Delaware	19803	Completed
University of Florida Jacksonville Shands Medical Center	Jacksonville	Florida	32209	Completed
Kapiolani Womens and Childrens Medical Center	Honolulu	Hawaii	96826	Completed
Ann and Robert H. Lurie Childrens Hospital of Chicago	Chicago	Illinois	60611	Completed
Ann and Robert H. Lurie Childrens Hospital of Chicago	Chicago	Illinois	60614	Completed
Riley Hospital for Children at Indiana University	Indianapolis	Indiana	46202	Completed
University of Iowa Stead Family Children's Hospital	Iowa City	Iowa	52242	Completed
University of Kansas Medical Center-JG Kidney Institute	Kansas City	Kansas	66160	Completed
University of Louisville Norton Childrens Hospital	Louisville	Kentucky	40202	Completed
Tulane University Health Science Center	New Orleans	Louisiana	70112	Completed
Ochsner Baptist Clinical Trials Unit	New Orleans	Louisiana	70115	Completed
University of Maryland Medical Center	Baltimore	Maryland	21201	Completed
Boston Children's Hospital	Boston	Massachusetts	02115	Completed
Massachusetts General Hospital	Lexington	Massachusetts	02421	Completed
University of Minnesota	Minneapolis	Minnesota	55455	Completed
University of Mississippi Medical Center	Jackson	Mississippi	39216	Completed
Mississippi Center for Advanced Medicine	Madison	Mississippi	39110	Completed
Children's Mercy Hospital	Kansas City	Missouri	64108	Completed
University of Nebraska Medical Center	Omaha	Nebraska	68114	Completed
Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	03756	Completed
University of New Mexico Health Science Center	Albuquerque	New Mexico	87131	Completed
University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	27599	Completed
Duke University Health System	Durham	North Carolina	27710	Recruiting
Cincinnati Childrens Hospital Medical Center	Cincinnati	Ohio	45229	Recruiting
Board of Regents of the University of Oklahoma	Oklahoma City	Oklahoma	73104	Completed
Oregon Health and Science University	Portland	Oregon	97239	Completed
Pennsylvania State University--Hershey Children's Hospital	Hershey	Pennsylvania	17033	Completed
Rhode Island Hospital	Providence	Rhode Island	02903	Completed
Medical University of South Carolina Children's Hospital	Charleston	South Carolina	29425	Completed
University of South Carolina	Columbia	South Carolina	29208	Completed
Avera McKennan Hospital & University Medical Center	Sioux Falls	South Dakota	57108	Completed
Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee	37232	Completed
Dell Children's Medical Center of Central Texas	Austin	Texas	78723	Recruiting
University of Texas-Southwestern Medical Center Dallas	Dallas	Texas	75390	Completed
Baylor College of Medicine	Houston	Texas	77030	Completed
University of Texas--Memorial Hermann Texas Medical Center	Houston	Texas	77030	Completed
The Womens Hospital of Texas	Houston	Texas	77054	Completed
University of Utah	Salt Lake City	Utah	84113	Completed
Seattle Children's Hospital	Seattle	Washington	98105	Completed
West Virginia University Hospital	Morgantown	West Virginia	26506	Completed
University of Wisconsin	Madison	Wisconsin	53705	Completed
University Wisconsin Madison	Madison	Wisconsin	53705	Completed
Medical College of Wisconsin	Milwaukee	Wisconsin	53226	Completed

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04278404, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 20, 2026 · Synced Sep 1, 2026

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The complete protocol, eligibility criteria, and contact information for NCT04278404 live on ClinicalTrials.gov.

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