PK Analysis in Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care - Ondansetron

PK analysis data
Study Description
Aim: Characterize the pharmacokinetics (PK) of ondansetron administered to children per standard of care as prescribed by their treating caregiver. Methods: The PK and safety analyses in this report include ondansetron data from NICHD-2011-POP01 (“Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care”), a multicenter, prospective opportunistic PK study of understudied drugs in children less than 21 years of age who receive drugs per standard of care, as prescribed by a treating caregiver. The NICHD-2011-POP01 study enrolls participants under multiple drugs of interest (DOI) including ondansetron, and continues to enroll participants under other DOIs.
Results: No AEs or SAEs related to study procedures were reported. No serious, unexpected, suspected, adverse reactions to Ondansetron were reported. 109 participants enrolled under ondansetron, 93 (85.3%) were eligible for the PK analysis. One participant enrolled in two 90-day enrollment segments.