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Recommendations for the Design of Clinical Drug-Drug Interaction Studies With Itraconazole Using a Mechanistic Physiologically-Based Pharmacokinetic Model.

التفاصيل البيبلوغرافية
العنوان: Recommendations for the Design of Clinical Drug-Drug Interaction Studies With Itraconazole Using a Mechanistic Physiologically-Based Pharmacokinetic Model.
المؤلفون: Chen Y; Department of Drug Metabolism and Pharmacokinetics, Genentech Inc., a member of the Roche Group, South San Francisco, California, USA., Cabalu TD; Department of Pharmacokinetics, Pharmacodynamics, and Drug Metabolism, Merck & Co., Inc., Kenilworth, New Jersey, USA., Callegari E; Pharmacokinetics, Dynamics and Metabolism, Pfizer Inc., Groton, Connecticut, USA., Einolf H; Modeling & Simulation, PK Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey, USA., Liu L; Genentech Inc., a member of the Roche Group, South San Francisco, California, USA., Parrott N; Pharmaceutical Sciences, Pharmaceutical Research and Early Development, Roche Innovation Centre, Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland., Peters SA; Translational Quantitative Pharmacology, Merck KGaA, Darmstadt, Germany., Schuck E; Modeling & Simulation, Clinical Pharmacology Science/Medicine Development Center (MDC), Eisai Inc., Woodcliff Lake, New Jersey, USA., Sharma P; Mechanistic Safety and ADME Sciences, Drug Safety and Metabolism, Innovative Medicines (IMED) Biotech Unit , AstraZeneca R&D, Cambridge, UK., Tracey H; Department of Mechanistic Safety and Disposition, GlaxoSmithKline, Hertfordshire, UK., Upreti VV; Clinical Pharmacology Modeling and Simulation, Amgen Inc., South San Francisco, California, USA., Zheng M; Clinical Pharmacology and Pharmacometrics, Bristol-Myers Squibb Company, Princeton, New Jersey, USA., Zhu AZX; Department of Drug Metabolism and Pharmacokinetics, Takeda Pharmaceuticals International Co., Cambridge, Massachusetts, USA., Hall SD; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA.
المصدر: CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2019 Sep; Vol. 8 (9), pp. 685-695. Date of Electronic Publication: 2019 Aug 07.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Wiley Country of Publication: United States NLM ID: 101580011 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2163-8306 (Electronic) Linking ISSN: 21638306 NLM ISO Abbreviation: CPT Pharmacometrics Syst Pharmacol Subsets: MEDLINE
أسماء مطبوعة: Publication: 2015- : Hoboken, NJ : Wiley
Original Publication: New York, NY : Nature Pub. Group
مواضيع طبية MeSH: Cytochrome P-450 CYP3A/*metabolism , Itraconazole/*pharmacokinetics, Area Under Curve ; Drug Dosage Calculations ; Drug Interactions ; Food-Drug Interactions ; Humans ; Itraconazole/pharmacology ; Models, Statistical
مستخلص: Regulatory agencies currently recommend itraconazole (ITZ) as a strong cytochrome P450 3A (CYP3A) inhibitor for clinical drug-drug interaction (DDI) studies. This work by an International Consortium for Innovation and Quality in Pharmaceutical Development working group (WG) is to develop and verify a mechanistic ITZ physiologically-based pharmacokinetic model and provide recommendations for optimal DDI study design based on model simulations. To support model development and verification, in vitro and clinical PK data for ITZ and its metabolites were collected from WG member companies. The model predictions of ITZ DDIs with seven different CYP3A substrates were within the guest criteria for 92% of area under the concentration-time curve ratios and 95% of maximum plasma concentration ratios, thus verifying the model for DDI predictions. The verified model was used to simulate various clinical DDI study scenarios considering formulation, duration of dosing, dose regimen, and food status to recommend the optimal design for maximal inhibitory effect by ITZ.
(© 2019 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics.)
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المشرفين على المادة: 304NUG5GF4 (Itraconazole)
EC 1.14.14.1 (CYP3A protein, human)
EC 1.14.14.1 (Cytochrome P-450 CYP3A)
تواريخ الأحداث: Date Created: 20190620 Date Completed: 20200819 Latest Revision: 20200819
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC6765698
DOI: 10.1002/psp4.12449
PMID: 31215774
قاعدة البيانات: MEDLINE
الوصف
تدمد:2163-8306
DOI:10.1002/psp4.12449