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Published on: November 8, 2015
Quantitation of TAK-981 in human plasma via LC-MS/MS and its application in clinical trials
Feng Yin1, Ran Ye1, Anson Pierce1
1Takeda Development Center Americas, Inc, Cambridge, MA, USA.
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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