biostudies-literatureMaglalang PDEunice Kennedy Shriver National Institute of Child Health and Human DevelopmentNICHD NIH HHS885-899https://www.ebi.ac.uk/biostudies/studies/S-EPMC11225543biostudies-literatureUnknown63(6)<h4>Background</h4>Levetiracetam is an antiseizure medication used for several seizure types in adults and children aged 1 month and older; however, due to a lack of data, pharmacokinetic (PK) variability of levetiracetam is not adequately characterized in certain populations, particularly neonates, children younger than 2 years of age, and children older than 2 years of age with obesity.<h4>Objective</h4>This study aimed to address the gap by leveraging PK data from two prospective standard-of-care pediatric trials (n = 88) covering an age range from 1 month to 19 years, including those with obesity (64%), and applying a physiologically based PK (PBPK) modeling framework.<h4>Methods</h4>A published PBPK model of levetiracetam for children aged 2 years and older was extended to pediatric pClinical pharmacokineticsApplication of Physiologically Based Pharmacokinetic Modeling to Characterize the Effects of Age and Obesity on the Disposition of Levetiracetam in the Pediatric Population.PMC11225543HHSN275201000003CR01 HD0964355R01HD096435HHSN275201000003IT32 HD104576R01 HD102949West LMcCann SClark KJefferson GMilleson CSimone GCraven STalbert JParsons AJohn RMourani PCapozzi TDix MTaylor LFearn LShakespear KKennel PTaylor JVitou BJames LPohl DHornik CTuttle AEubanks SKowal KFinkelstein YTiedge HMcMillan HNielsen CGerhardt BGonzalez DOldham MWrenn SRathore MMottes TTaravath SKearns GLDesmarasis DLacaze TKlipner KShankar KHornik CDBlackford MSpeicher DHoward LMalone KLapid AHoward EOdero NAl-Uzri ADeville JBaez AHarper CBerkovitch MDenne SGrzesek KRutebemberwa AKernen KRalston KYogev RPoff SAutmizguine JMassicotte CMyer DAnn DPShiloh-Malawsky YKohn EKonow CMuller WJReed MAdams RWiseheart MBradley GIeradi SKirby CZimmerman KHornik CPAnthony HBaisden NO'Connor KGoldstein SDelmore PPoindexter BVan KLang EKost BSinha JStryjewski GMuller WSierra YLakhotia AMichael ATraisman BSokol GAlger FWatt KSherwin CSargent JMurchison BLaughon MComings JSalman YZemek RMariconti ABeci RGoldenberg NChen LAnand RMeyer MWade KSroka PDixit SDeschenes JTerrell TSund ZMartinez MLitalien CSteinbeiss MChen JYJolly MBernhardt JOpel KBenjamin DKHodge APetersen LToltzis PMaglalang PDPaul IMBlanks TFilar LThoma KSullivan JArnold SPerrin EMArnold PShimizu JAlderman CSimeon TBest Pharmaceuticals for Children Act–Pediatric Trials Network Steering CommitteeHarward MWalker ADrake ADePaoli BJoshi SLemon ERumantir MHart MRosen PTasi CPerry JPerez RGoldblatt EAbdel-Rahman SBurmester JCermak JJoshi CNarus JHalstenson GPayne EHansberry DBorges ABrown KAnderson CDumitrascu MSpigarelli MLague VMoore AEdginton ADiDomenico DfalseApplication of Physiologically Based Pharmacokinetic Modeling to Characterize the Effects of Age and Obesity on the Disposition of Levetiracetam in the Pediatric Population.<h4>Background</h4>Levetiracetam is an antiseizure medication used for several seizure types in adults and children aged 1 month and older; however, due to a lack of data, pharmacokinetic (PK) variability of levetiracetam is not adequately characterized in certain populations, particularly neonates, children younger than 2 years of age, and children older than 2 years of age with obesity.<h4>Objective</h4>This study aimed to address the gap by leveraging PK data from two prospective standard-of-care pediatric trials (n = 88) covering an age range from 1 month to 19 years, including those with obesity (64%), and applying a physiologically based PK (PBPK) modeling framework.<h4>Methods</h4>A published PBPK model of levetiracetam for children aged 2 years and older was extended to pediatric p2024-01-01T00:00:00Z2024 Jun2026-06-02T20:33:30.852Z2026-05-27T03:07:49.342ZS-EPMC112255433881442510.1007/s40262-024-01367-2