Quantitation of TAK-981 in human plasma via LC-MS/MS and its application in clinical trials.

IF 1.8 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS

Bioanalysis Pub Date : 2025-06-12 DOI:10.1080/17576180.2025.2518048

Feng Yin, Ran Ye, Anson Pierce, John Gibbs, Mike Baratta

引用次数: 0

Abstract

Aim: TAK-981 is a highly effective and selective inhibitor of the small ubiquitin-like modifier (SUMO) activating enzyme, and it promotes the expression of type I interferons (IFN-Is). Developing a sensitive bioanalytical assay for quantitating TAK-981 is essential in the clinical investigations for oncology drug development.

Materials & methods: TAK-981 and its stable isotope labeled compound (TAK-981¹³C₄, ¹⁵N₂) as the internal standard were employed in this LC-MS/MS assay.

Results: This assay was successfully validated from 0.1 ng/mL to 100 ng/mL with good accuracy and precision and has been applied to support clinical studies.

Conclusion: A sensitive and robust LC-MS/MS assay was validated for TAK-981 in human plasma for the first time.

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LC-MS/MS法测定人血浆中TAK-981的含量及其在临床试验中的应用

目的：TAK-981是一种高效、选择性的小泛素样修饰物（SUMO）激活酶抑制剂，可促进I型干扰素（IFN-Is）的表达。在肿瘤药物开发的临床研究中，开发一种灵敏的定量TAK-981的生物分析方法是必不可少的。材料与方法：采用TAK-981及其稳定同位素标记物（TAK-98113C4, 15N2）作为内标进行LC-MS/MS分析。结果：该方法在0.1 ng/mL ~ 100 ng/mL范围内验证成功，具有良好的准确度和精密度，可用于支持临床研究。结论：首次建立了测定人血浆中TAK-981的灵敏、可靠的LC-MS/MS方法。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Bioanalysis BIOCHEMICAL RESEARCH METHODS-CHEMISTRY, ANALYTICAL

CiteScore

3.30

自引率

16.70%

发文量

审稿时长

2 months

期刊介绍： Reliable data obtained from selective, sensitive and reproducible analysis of xenobiotics and biotics in biological samples is a fundamental and crucial part of every successful drug development program. The same principles can also apply to many other areas of research such as forensic science, toxicology and sports doping testing. The bioanalytical field incorporates sophisticated techniques linking sample preparation and advanced separations with MS and NMR detection systems, automation and robotics. Standards set by regulatory bodies regarding method development and validation increasingly define the boundaries between speed and quality. Bioanalysis is a progressive discipline for which the future holds many exciting opportunities to further reduce sample volumes, analysis cost and environmental impact, as well as to improve sensitivity, specificity, accuracy, efficiency, assay throughput, data quality, data handling and processing. The journal Bioanalysis focuses on the techniques and methods used for the detection or quantitative study of analytes in human or animal biological samples. Bioanalysis encourages the submission of articles describing forward-looking applications, including biosensors, microfluidics, miniaturized analytical devices, and new hyphenated and multi-dimensional techniques. Bioanalysis delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for the modern bioanalyst.