Studies how drugs given to children with several conditions act in the body
Measures how standard drugs act in children and young adults receiving them.
Plain-language title generated from the registry record
Registry title: Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Key facts
- Where
- Montreal and Toronto, CanadaSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 0 and 20 years old?
Source: NCT04278404, who can take part
Where in Canada
- CHU Sainte-JustineMontreal, CanadaTaking people
- The Hospital for Sick ChildrenToronto, CanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Duke University
- Trial code
- NCT04278404
- Record updated
- 21 August 2026
- Original description
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.Read full original descriptionShow less
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs
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.
Inclusion: 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.
Exclusion: 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 any condition which would make the participant, in the opinion of the investigator, unsuitable for the study; Has a Ventricular Assist Device.