Tiered approach to evaluate the CYP3A victim and perpetrator drug-drug interaction potential for vonoprazan using PBPK modeling and clinical data to inform labeling.
Journal
CPT: pharmacometrics & systems pharmacology
ISSN: 2163-8306
Titre abrégé: CPT Pharmacometrics Syst Pharmacol
Pays: United States
ID NLM: 101580011
Informations de publication
Date de publication:
04 2023
04 2023
Historique:
revised:
19
01
2023
received:
16
09
2022
accepted:
23
01
2023
medline:
12
4
2023
pubmed:
11
3
2023
entrez:
10
3
2023
Statut:
ppublish
Résumé
Vonoprazan is metabolized extensively through CYP3A and is an in vitro time-dependent inhibitor of CYP3A. A tiered approach was applied to understand the CYP3A victim and perpetrator drug-drug interaction (DDI) potential for vonoprazan. Mechanistic static modeling suggested vonoprazan is a potential clinically relevant CYP3A inhibitor. Thus, a clinical study was conducted to evaluate the impact of vonoprazan on the exposure of oral midazolam, an index substrate for CYP3A. A physiologically-based pharmacokinetic (PBPK) model for vonoprazan was also developed using in vitro data, drug- and system-specific parameters, and clinical data and observations from a [
Identifiants
pubmed: 36896795
doi: 10.1002/psp4.12939
pmc: PMC10088082
doi:
Substances chimiques
Cytochrome P-450 CYP3A Inhibitors
0
Cytochrome P-450 CYP3A Inducers
0
Midazolam
R60L0SM5BC
Cytochrome P-450 CYP3A
EC 1.14.14.1
1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
532-544Informations de copyright
© 2023 Phathom Pharmaceuticals and The Authors. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.
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