Food effect trial of the pharmacokinetics and safety of TQ05105 in healthy Chinese subjects.

IF 2.3 4区医学 Q3 ONCOLOGY Cancer Chemotherapy and Pharmacology Pub Date : 2025-02-10 DOI:10.1007/s00280-025-04754-z

Jun Dai, Yang Cheng, Yannan Zhou, Yanli Wang, Zhengzhi Liu, Qing Ren, Zhengjie Su, Qiaohuan Deng, Haimiao Yang, Yingzi Cui

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Abstract

Purpose: This study aims to investigate the effect of food intake on the pharmacokinetics of TQ05105 tablets in healthy Chinese subjects, and to evaluate the safety in these subjects.

Methods: This Phase I clinical trial involved healthy subjects who received a single oral dose of 15 mg TQ05105, with a 2-day washout period between each period. The plasma concentrations of TQ05105 and its metabolite TQ12550 were quantified using a validated liquid chromatography-tandem mass spectrometry method. Safety assessments were conducted throughout the study.

Results: The study enrolled 16 healthy Chinese subjects (10 males and 6 females). Compared with the fasting condition, the postprandial administration of TQ05105 resulted in significant reductions in the maximum concentration (C_max) and area under the curve (AUC) of both TQ05105 and its metabolite TQ12550. Additionally, both the time to peak concentration (T_max) and half-life (t_1/2) of TQ05105 and its metabolite were prolonged under postprandial conditions. No serious adverse events were reported during the study.

Conclusion: The findings demonstrate that food intake significantly alters the pharmacokinetic parameters of TQ05105 and its metabolite TQ12550, with a notable decrease in C_max and AUC, and an increase in T_max and t_1/2. The single dose of the drug was well tolerated.

Registration information: This trial had registered at the Clinical Trials.gov on August 08, 2023 ( https://clinicaltrials.gov , NCT05982106).

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TQ05105在中国健康人体内药代动力学及安全性的食效试验。

目的：研究食物摄取量对TQ05105片在中国健康人体内药代动力学的影响，并评价其安全性。方法：这项I期临床试验涉及健康受试者，他们接受单次口服15mg TQ05105，每期之间有2天的洗脱期。采用经验证的液相色谱-串联质谱法测定TQ05105及其代谢物TQ12550的血浆浓度。在整个研究过程中进行了安全性评估。结果：本研究招募了16名健康的中国受试者（男10名，女6名）。与空腹相比，餐后给药可显著降低TQ05105及其代谢物TQ12550的最大浓度（Cmax）和曲线下面积（AUC）。此外，餐后条件下，TQ05105及其代谢物的峰浓度时间（Tmax）和半衰期（t1/2）均延长。研究期间未见严重不良事件的报道。结论：食物摄入显著改变了TQ05105及其代谢物TQ12550的药动学参数，Cmax和AUC显著降低，Tmax和t1/2显著升高。单剂量的药物耐受性良好。注册信息：该试验已于2023年8月8日在Clinical Trials.gov注册（https://clinicaltrials.gov, NCT05982106）。

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来源期刊

Cancer Chemotherapy and Pharmacology 医学-药学

CiteScore

6.10

自引率

3.30%

发文量

116

审稿时长

2.5 months

期刊介绍： Addressing a wide range of pharmacologic and oncologic concerns on both experimental and clinical levels, Cancer Chemotherapy and Pharmacology is an eminent journal in the field. The primary focus in this rapid publication medium is on new anticancer agents, their experimental screening, preclinical toxicology and pharmacology, single and combined drug administration modalities, and clinical phase I, II and III trials. It is essential reading for pharmacologists and oncologists giving results recorded in the following areas: clinical toxicology, pharmacokinetics, pharmacodynamics, drug interactions, and indications for chemotherapy in cancer treatment strategy.