通过液相色谱-串联质谱法对人血浆中的TAK-981进行定量分析及其在临床试验中的应用。
Quantitation of TAK-981 in human plasma via LC-MS/MS and its application in clinical trials.
作者信息
Yin Feng, Ye Ran, Pierce Anson, Gibbs John, Baratta Mike
机构信息
Takeda Development Center Americas, Inc, Cambridge, MA, USA.
出版信息
Bioanalysis. 2025 Jun;17(12):795-805. doi: 10.1080/17576180.2025.2518048. Epub 2025 Jun 12.
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-981C, N) 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.
目的
TAK-981是一种高效且具有选择性的小泛素样修饰物（SUMO）激活酶抑制剂，它能促进I型干扰素（IFN-Is）的表达。开发一种灵敏的生物分析方法来定量TAK-981对于肿瘤药物研发的临床研究至关重要。
材料与方法
在该液相色谱-串联质谱（LC-MS/MS）分析中采用TAK-981及其稳定同位素标记化合物（TAK-981C，N）作为内标。
结果
该分析方法在0.1 ng/mL至100 ng/mL范围内成功验证，具有良好的准确度和精密度，并已应用于支持临床研究。
结论
首次在人血浆中验证了一种灵敏且稳健的TAK-981的LC-MS/MS分析方法。
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