Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Recruiting now NCT04278404
Run by Duke University · for 0 to 20 · All sexes · accepts healthy volunteers
What this study is about
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.
Who can join (things the study team will check)
✅ You may be able to join if…
- Participant is < 21 years of age
- Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA:
- (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment
🚫 You may not be able to join if…
- Participant has a known pregnancy Below exclusion criteria apply only to: Participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria)
- Has had intermittent dialysis within previous 24 hours
- Has had a kidney transplant within previous 30 days
- Has had a liver transplant within previous 1 year
- Has had a stem cell transplant within previous 1 year
- Has had therapeutic hypothermia within previous 24 hours
- Has had plasmapheresis within the previous 24 hours
- Has a Ventricular Assist Device
- Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Where this trial is running
- Phoenix Children's Hospital, Phoenix, Arizona, United States
- Arkansas Children's Hospital Research Institute, Little Rock, Arkansas, United States
- University of California, Los Angeles Medical Center, Los Angeles, California, United States
- Lucile Packard Children's Hospital, Palo Alto, California, United States
- Colorado University Denver, Aurora, Colorado, United States
- The Children's Hospital Colorado, Aurora, Colorado, United States
- Alfred I. DuPont Hospital for Children, Wilmington, Delaware, United States
- University of Florida Jacksonville Shands Medical Center, Jacksonville, Florida, United States
- Kapiolani Womens and Childrens Medical Center, Honolulu, Hawaii, United States
- Ann and Robert H. Lurie Childrens Hospital of Chicago, Chicago, Illinois, United States
- Ann and Robert H. Lurie Childrens Hospital of Chicago, Chicago, Illinois, United States
- Riley Hospital for Children at Indiana University, Indianapolis, Indiana, United States
+ 39 more sites.
Who to contact
Chi Hornik · (919) 260-7626 · chi.hornik@duke.edu
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT04278404.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.