Methadone Pharmacokinetics and Cardiac Effects in Newborns
Status:
Completed
Trial end date:
2017-02-10
Target enrollment:
Participant gender:
Summary
The Primary objectives of this proposal are to determine the population kinetics for
methadone and its enantiomers in preterm newborns and infants at 29 weeks to 48 weeks post
menstrual age (PMA) who are 1 week old and older and establish any correlations of the
kinetics with PMA to determine the bioavailability for enterally administered methadone in
these newborns and young infants.
The secondary objectives of this proposal are to explore possible genotypic changes in
CYP3A4-3A7-3A5, CYP2B6, CYP2C8, CYP2C19, and CYP2D6 and PGO on the kinetics of methadone in
neonates and young infants and to test the safety of methadone in this population by
correlating the plasma concentrations of the methadone enantiomers, S-methadone and
R-methadone, with changes in cardiac repolarization by measurement of corrected QT, heart
rate, and blood pressure.
Phase:
Phase 1
Details
Lead Sponsor:
University of Utah
Collaborators:
Case Western Reserve University Children's Mercy Hospital Kansas City Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)