ArticleCPT: pharmacometrics & systems pharmacology2019
Recommendations for the Design of Clinical Drug-Drug Interaction Studies With Itraconazole Using a Mechanistic Physiologically-Based Pharmacokinetic Model.
Article in CPT: pharmacometrics & systems pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
29 citing papers in PubMed.
- Pharmacokinetics and Safety of Lurbinectedin Administrated with Itraconazole in Cancer Patients: A Drug-Drug Interaction Study.Marine drugs · 2024Trial
- Drug Interactions of Vebreltinib, a Novel Type I c-Met Inhibitor, Coadministration With Rifampin or Itraconazole in Healthy Participants.Clinical and translational science · 2026Article
- Pharmacokinetic Drug Interaction Studies of Limnetrelvir with Midazolam and Itraconazole in Healthy Participants.Clinical drug investigation · 2026Article
- Dynamic regulatory mechanism of cholesterol 25-hydroxylase-mediated antiviral response in RNA virus infections.Frontiers in cellular and infection microbiology · 2026Review
- Application of Physiologically-Based Pharmacokinetic Modeling to Support Drug Labeling: Prediction of CYP3A4-Mediated Pirtobrutinib-Drug Interactions.CPT: pharmacometrics & systems pharmacology · 2025Article
- The Effects of Ritonavir on the Pharmacokinetics of Tofacitinib in Rats.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Physiologically Based Pharmacokinetic Modeling and Simulations in Lieu of Clinical Pharmacology Studies to Support the New Drug Application of Asciminib.Pharmaceutics · 2025Article
- Evaluation of Potential Effects of CYP3A Inhibition and CYP3A Induction on the Pharmacokinetics of Fruquintinib in Healthy Subjects.Clinical pharmacology in drug development · 2025Article
- Sensitivity of Tepotinib to Inhibitors or Inducers of CYP3A4 and P-Gp: Drug Interaction Studies and Physiologically-Based Pharmacokinetic Analysis.Clinical and translational science · 2025Article
- Physiologically Based Pharmacokinetic Modeling to Predict Drug-Drug Interactions of Soticlestat as a Victim of CYP Induction and Inhibition, and as a Perpetrator of CYP and P-Glycoprotein Inhibition.Clinical pharmacology in drug development · 2025Article
- Deconvoluting zavegepant drug-drug interactions: A phase I study to evaluate the effects of rifampin and itraconazole on zavegepant pharmacokinetics.Clinical and translational science · 2024Article
- Evaluation of drug-drug interactions of a novel potent FLT3 inhibitor SKLB1028 in healthy subjects.Clinical and translational science · 2024Article
- An open-label study to explore the optimal design of CYP3A drug-drug interaction clinical trials in healthy Chinese people.Pharmacology research & perspectives · 2024Article
- The effect of itraconazole, a strong CYP3A4 inhibitor, on the pharmacokinetics of the first-in-class ACKR3/CXCR7 antagonist, ACT-1004-1239.Clinical and translational science · 2024Article
- Assessing the relative contribution of CYP3A-and P-gp-mediated pathways to the overall disposition and drug-drug interaction of dabigatran etexilate using a comprehensive mechanistic physiological-based pharmacokinetic model.Frontiers in pharmacology · 2024Article
- Validation of a method for itraconazole and major metabolite hydroxyitraconazole for LC-MS/MS analysis with application in a formulation clinical study.Journal of pharmaceutical and biomedical analysis · 2023Article
- Pharmacokinetics and Drug-Drug Interaction of Ocedurenone (KBP-5074) in vitro and in vivo.European journal of drug metabolism and pharmacokinetics · 2023Article
- Clinical assessment of gepotidacin (GSK2140944) as a victim and perpetrator of drug-drug interactions via CYP3A metabolism and transporters.Clinical and translational science · 2023Article
- Evaluation of the Pharmacokinetic Drug Interaction of Capmatinib With Itraconazole and Rifampicin and Potential Impact on Renal Transporters in Healthy Subjects.Journal of clinical pharmacology · 2023Article
- Physiologically-based pharmacokinetic modeling for primary metabolites of CYP3A and P-glycoprotein inhibitors in drug-drug interactions: Should we assume the free drug hypothesis?CPT: pharmacometrics & systems pharmacology · 2023Article
Corrections and comments
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Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
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