Non-Participant Specific Protocol Devation in Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care - Methadone

Non-Participant Specific Protocol Devation data
Study Description
Aim: Characterize the pharmacokinetics (PK) of methadone administered to children per standard of care to address gap in pediatric labeling. Methods: The PK and safety analyses include methadone data from NICHD-2011-POP01 (“PK 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. This study enrolls participants under multiple drugs of interest (DOI) including methadone, and continues to enroll participants under other DOIs. Data from this study was analyzed as part of NICHD-2013-MTH01 study. Results: There were no AEs related to study drug and all changes in laboratory values were clinically insignificant. Analyses of new diagnoses and clinical laboratory data from POP01 retrospective chart review suggest that methadone was well-tolerated in participants who received methadone indicated for pain. Children <21 years of age who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver