Population Pharmacokinetics of Baloxavir Marboxil in Japanese Pediatric Influenza Patients |
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| Affiliation: | 1. Respiratory Technology, Woolcock Institute of Medical Research and Discipline of Pharmacology, Faculty of Medicine and Health, The University of Sydney, 431 Glebe Point Road, Glebe, New South Wales 2037, Australia;2. Department of Life Sciences and Biotechnology, Master Course in Cosmetic Science and Technology (COSMAST), University of Ferrara, Via L. Borsari 46, 44121 Ferrara, Italy;1. Drug Metabolism and Pharmacokinetics-Translational Modeling, AbbVie Inc., North Chicago, Illinois 60064;2. University of Sao Paulo, Sao Paulo, Brazil;1. Pharmacokinetics, Dynamics, and Metabolism, Pfizer Worldwide Research & Development, San Diego, California 92121;1. College of Life Science and Technology, Guangxi University, Nanning 530004, China;2. Medical College, Guangxi University, Nanning 530004, China;3. School of Chemistry and Chemical Engineering, Guangxi University, Nanning 530004, China;4. Guangxi Institute for Food and Drug Control, Nanning 530021, China |
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| Abstract: | Baloxavir marboxil is a prodrug of baloxavir acid, an inhibitor of cap-dependent endonuclease, and suppresses the replication of influenza virus. The aim of this study was to investigate its pharmacokinetic characteristics in Japanese pediatrics. Population pharmacokinetic analysis was conducted for baloxavir acid with 328 plasma concentration data points in a clinical study of 107 Japanese pediatric influenza patients. The plasma baloxavir acid concentration profiles were well captured by a 2-compartment model including first-order absorption and lag time. Body weight was considered to be the most crucial covariate, which affects clearance and volume of distribution. The body weight–based dose regimen (10 mg for 10 kg to less than 20 kg pediatrics, 20 mg for 20 kg to less than 40 kg pediatrics, and 40 mg for at least 40 kg pediatrics) for Japanese pediatrics can provide comparable exposure to baloxavir acid to that for adults. In conclusion, the population pharmacokinetic model would be useful to comprehend the characteristics of baloxavir acid pharmacokinetics in pediatric patients. |
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| Keywords: | baloxavir marboxil cap-dependent endonuclease inhibitor influenza population pharmacokinetics Japanese pediatrics S-033188 |
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