A drug-drug interaction study of ibrutinib with moderate/strong CYP3A inhibitors in patients with B-cell malignancies

Autor:	Carlos Panizo, Jan de Jong, James Jiao, Daniel Patricia, Peter Hellemans, Raul Cordoba, Juthamas Sukbuntherng, Daniele Ouellet, Severijn De Wilde, Vijay Chauhan, Alexander Myasnikov, Loeckie de Zwart, Dzhelil Osmanov, Georgii Manikhas, Jan Snoeys, Tara Masterson
Rok vydání:	2018
Předmět:	0301 basic medicine Diarrhea Male Cancer Research Neutropenia CYP3A Erythromycin Administration Oral Pharmacology Polymorphism Single Nucleotide Drug Administration Schedule 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Pharmacokinetics Piperidines Antineoplastic Combined Chemotherapy Protocols medicine Cytochrome P-450 CYP3A Humans In patient Drug Interactions B cell Aged Voriconazole Aged 80 and over B-Lymphocytes Dose-Response Relationship Drug business.industry Adenine Hematology Drug interaction Middle Aged Cytochrome P-450 CYP2C19 030104 developmental biology medicine.anatomical_structure Pyrimidines Oncology chemistry 030220 oncology & carcinogenesis Ibrutinib Hematologic Neoplasms Cytochrome P-450 CYP3A Inhibitors Pyrazoles Female business medicine.drug
Zdroj:	Leukemialymphoma. 59(12)
ISSN:	1029-2403
Popis:	This was an open-label, multicenter, phase-1 study to evaluate the drug interaction between steady-state ibrutinib and moderate (erythromycin) and strong (voriconazole) CYP3A inhibitors in patients with B-cell malignancies and to confirm dosing recommendations. During cycle 1, patients received oral ibrutinib 560 mg qd alone (Days 1-4 and 14-18), and ibrutinib 140 mg (Days 5-13; 19-27) plus erythromycin 500 mg tid (Days 5-11) and voriconazole 200 mg bid (Days 19-25). Twenty-six patients (median [range] age: 64.5 [50-88] years) were enrolled. Geometric mean ratio (90% confidence intervals) after co-administration of ibrutinib 140 mg with erythromycin and voriconazole was 74.7 (53.97-103.51) and 143.3 (107.77-190.42), respectively, versus ibrutinib 560 mg alone. The most common (≥20%) adverse events were diarrhea (27%) and neutropenia (23%). The results demonstrate that ibrutinib 140 mg with voriconazole or erythromycin provides exposure within the clinical range for patients with B-cell malignancies.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4cb27f8dc6d9faee6f909785cb93ac11 https://pubmed.ncbi.nlm.nih.gov/29846137 Zobrazit plný text záznamu Plný text ve formátu PDF Plný text ve formátu HTML
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