2,000
Participants
Start Date
October 5, 2021
Primary Completion Date
October 30, 2025
Study Completion Date
October 30, 2026
The OPTIC study is collecting PK data on children prescribed understudied drugs of interest per standard of care.
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.
RECRUITING
Duke University Medical Center, Durham
Lead Sponsor
Food and Drug Administration (FDA)
FED
Duke University
OTHER