Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs
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 Criteria:
Exclusion Criteria:
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
chi.hornik@duke.edu(919) 260-7626
melissa.james@duke.edu(704) 502-6491
Los Angeles, California 90095, United States
Jacksonville, Florida 32209, United States
Chicago, Illinois 60611, United States
Chicago, Illinois 60614, United States
Indianapolis, Indiana 46202, United States
Kansas City, Kansas 66160, United States
Louisville, Kentucky 40202, United States
Chapel Hill, North Carolina 27599, United States
Hershey, Pennsylvania 17033, United States
Charleston, South Carolina 29425, United States
Sioux Falls, South Dakota 57108, United States
Nashville, Tennessee 37232, United States
Houston, Texas 77030, United States
yasinour@stanford.edu650-724-4548
shelbyb@stanford.edu650-704-2186
melissa.harward@dm.duke.edu919-668-3910
bethany.kistler@duke.edu919-681-2554
kelli.krallman@cchmc.org513-636-4837
michaela.collins@cchmc.org513-803-7340
michael.box@ascension-external.org512-820-2136
jeremy.kulwin@ascension-external.org
clotilde.gravel.hsj@ssss.gouv.qc.ca514-345-4931
vincent.lague.hsj@ssss.gouv.qc.ca514-345-4931