1. Population pharmacokinetics of naloxegol in paediatric subjects receiving opioids
- Author
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Mary Ann Mascelli, Matthew W Hruska, Sam Liao, Lori Liao, Patrick Davies, Jennifer Kong, and Douglas A Marsteller
- Abstract
Purpose To characterize the pharmacokinetics (PK) of naloxegol in paediatric subjects (≥ 6 months to Methods Subjects in three age groups (≥12 to Results Naloxegol exhibits comparable PK characteristics in paediatric and adult subjects. Neither age nor body weight was identified as a significant covariate in the prior (adult only data), or current model. Naloxegol NCA- and PPK-derived AUC0–∞ values normalized to the adult 12.5 mg or 25 mg dose in the ≥6 to 0–∞ values for the 25 mg adult equivalent dose for all paediatric age groups were comparable to adults. Conclusion The PK of naloxegol was well characterized in paediatric subjects ≥ 6 months of age utilizing both NCA and PPK analysis and was shown to be comparable to adult subjects.
- Published
- 2023
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