Jun Dai, Yang Cheng, Yannan Zhou, Yanli Wang, Zhengzhi Liu, Qing Ren, Zhengjie Su, Qiaohuan Deng, Haimiao Yang, Yingzi Cui
{"title":"TQ05105在中国健康人体内药代动力学及安全性的食效试验。","authors":"Jun Dai, Yang Cheng, Yannan Zhou, Yanli Wang, Zhengzhi Liu, Qing Ren, Zhengjie Su, Qiaohuan Deng, Haimiao Yang, Yingzi Cui","doi":"10.1007/s00280-025-04754-z","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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<sub>max</sub>) and area under the curve (AUC) of both TQ05105 and its metabolite TQ12550. Additionally, both the time to peak concentration (T<sub>max</sub>) and half-life (t<sub>1/2</sub>) of TQ05105 and its metabolite were prolonged under postprandial conditions. No serious adverse events were reported during the study.</p><p><strong>Conclusion: </strong>The findings demonstrate that food intake significantly alters the pharmacokinetic parameters of TQ05105 and its metabolite TQ12550, with a notable decrease in C<sub>max</sub> and AUC, and an increase in T<sub>max</sub> and t<sub>1/2</sub>. The single dose of the drug was well tolerated.</p><p><strong>Registration information: </strong>This trial had registered at the Clinical Trials.gov on August 08, 2023 ( https://clinicaltrials.gov , NCT05982106).</p>","PeriodicalId":9556,"journal":{"name":"Cancer Chemotherapy and Pharmacology","volume":"95 1","pages":"31"},"PeriodicalIF":2.7000,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Food effect trial of the pharmacokinetics and safety of TQ05105 in healthy Chinese subjects.\",\"authors\":\"Jun Dai, Yang Cheng, Yannan Zhou, Yanli Wang, Zhengzhi Liu, Qing Ren, Zhengjie Su, Qiaohuan Deng, Haimiao Yang, Yingzi Cui\",\"doi\":\"10.1007/s00280-025-04754-z\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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<sub>max</sub>) and area under the curve (AUC) of both TQ05105 and its metabolite TQ12550. Additionally, both the time to peak concentration (T<sub>max</sub>) and half-life (t<sub>1/2</sub>) of TQ05105 and its metabolite were prolonged under postprandial conditions. No serious adverse events were reported during the study.</p><p><strong>Conclusion: </strong>The findings demonstrate that food intake significantly alters the pharmacokinetic parameters of TQ05105 and its metabolite TQ12550, with a notable decrease in C<sub>max</sub> and AUC, and an increase in T<sub>max</sub> and t<sub>1/2</sub>. The single dose of the drug was well tolerated.</p><p><strong>Registration information: </strong>This trial had registered at the Clinical Trials.gov on August 08, 2023 ( https://clinicaltrials.gov , NCT05982106).</p>\",\"PeriodicalId\":9556,\"journal\":{\"name\":\"Cancer Chemotherapy and Pharmacology\",\"volume\":\"95 1\",\"pages\":\"31\"},\"PeriodicalIF\":2.7000,\"publicationDate\":\"2025-02-10\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Cancer Chemotherapy and Pharmacology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s00280-025-04754-z\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cancer Chemotherapy and Pharmacology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00280-025-04754-z","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}
Food effect trial of the pharmacokinetics and safety of TQ05105 in healthy Chinese subjects.
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 (Cmax) and area under the curve (AUC) of both TQ05105 and its metabolite TQ12550. Additionally, both the time to peak concentration (Tmax) and half-life (t1/2) 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 Cmax and AUC, and an increase in Tmax and t1/2. 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).
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.
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