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04-05-2024 | Pharmacokinetics | Original Article

Effect of food on the pharmacokinetics and safety profiles of a new PARP inhibitor fuzuloparib capsules in healthy volunteers

Authors: Pengfei Du, Yao Long, Minhui Wang, Yunzhe Huang, Yaqin Wang, Xinyan Chen, Yuhong Lin, Jianbang Wu, Jie Shen, Yuanwei Jia

Published in: Cancer Chemotherapy and Pharmacology

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Abstract

Purpose

This study assessed effect of food on pharmacokinetics (PK) and safety of fuzuloparib capsules.

Methods

A randomized, open-label, two-cycle, two-sequence, crossover clinical trial was conducted. 20 subjects were randomly assigned to 2 groups at a 1:1 ratio. The first group subjects were orally administered 150 mg fuzuloparib capsules under fasting condition in first dosing cycle. The same dose of fuzuloparib capsules were taken under postprandial state after a 7-day washout period. The second group was reversed. 3 ml whole blood was collected at each blood collection point until 72 h post dose. PK parameters were calculated. Furthermore, safety assessment was performed.

Results

The time to maximum concentration (Tmax) was prolonged to 3 h and maximum concentration (Cmax) decreased by 18.6% on high-fat diets. 90% confidence intervals (CIs) of geometric mean ratios (GMRs) for Cmax, area under the concentration–time curve from time zero to time t (AUC0−t), and area under the concentration–time curve extrapolated to infinity (AUC0−∞) after high-fat meal were 71.6–92.6%, 81.7–102.7% and 81.6–102.5%, respectively. All treatment-emergent adverse events (TEAEs) were grade 1; No serious adverse events (SAEs), serious unexpected suspected adverse reaction (SUSAR) or deaths were reported.

Conclusion

Food decreased the absorption rate and slowed time to peak exposure of fuzuloparib capsules, without impact on absorption extent. Dosing with food was found to be safe for fuzuloparib capsules in this study.

Clinical trial registration.

This study was registered with chinadrugtrials.org.cn (identifier: CTR20221498).
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Literature
Metadata
Title
Effect of food on the pharmacokinetics and safety profiles of a new PARP inhibitor fuzuloparib capsules in healthy volunteers
Authors
Pengfei Du
Yao Long
Minhui Wang
Yunzhe Huang
Yaqin Wang
Xinyan Chen
Yuhong Lin
Jianbang Wu
Jie Shen
Yuanwei Jia
Publication date
04-05-2024
Publisher
Springer Berlin Heidelberg
Published in
Cancer Chemotherapy and Pharmacology
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-024-04672-6
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