ArticleCancer chemotherapy and pharmacology2023
Itraconazole interferes in the pharmacokinetics of fuzuloparib in healthy volunteers.
Article in Cancer chemotherapy and pharmacology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
2 citing papers in PubMed, 4 citations in OpenAlex.
- Effect of food on the pharmacokinetics and safety profiles of a new PARP inhibitor fuzuloparib capsules in healthy volunteers.Cancer chemotherapy and pharmacology · 2024Trial
- Evaluation of Olaparib Tablet Safety and Pharmacokinetics in Healthy Chinese Male Subjects.Drug design, development and therapy · 2024Trial
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Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveFuzuloparib is an orally administered poly [ADP-ribose] polymerase 1 (PARP1) inhibitor and has potential anti-tumor effect on ovarian cancer (such as fallopian tube cancer and primary peritoneal cancer) in China. As fuzuloparib is metabolized mainly by CYP3A4, we explored the effect of itraconazole, a strong CYP3A4 inhibitor, on a single oral dose of fuzuloparib in healthy male subjects.
methodsAn open-label, single-arm, fixed sequence study was conducted. Twenty healthy adult males received one single dose of fuzuloparib (20 mg) with one dose administered alone and the other dose coadministered with itraconazole. Subjects received 200 mg QD itraconazole for 6 days during the study. Serials of blood samples were collected pre-dose of each fuzuloparib capsule administration and 48 h post-dose, and were used to analyze the PK parameters of fuzuloparib.
resultsCoadministration of repeated 200 mg QD oral doses of itraconazole for 6 days increased fuzuloparib exposure by 1.51-fold and 4.81-fold for peak plasma concentration and area under the plasma concentration-time curve (AUC), respectively. Oral administration of 20 mg fuzuloparib alone or together with itraconazole was safe and tolerable in healthy male subjects.
conclusionThe CYP3A4 inhibitor itraconazole has a significant influence on the PK behavior of fuzuloparib, suggesting to avoid using strong CYP3A4 inhibitors simultaneously with fuzuloparib. If it is necessary to use a strong CYP3A4 inhibitor, fuzuloparib would be discontinued and be restored to the original dose and frequency of administration after 5-7 half lives of CYP3A4 inhibitor stopped.
trial registrationhttp://www.chinadrugtrials.org.cn/index.html , CTR20191271.
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