Abstract
Aim: Isobutyrylcarnitine (IBC) is a possible biomarker for hepatic OCT1, as IBC plasma concentrations are reduced when OCT1 is inhibited. An accessible, characterized assay is needed to quantitate IBC in human plasma. Materials & methods: A triple quadrupole MS surrogate matrix assay for the quantitation of IBC was characterized to support a first-in-human study. Results: An assay for IBC quantitation was fully characterized for accuracy, precision, selectivity and parallelism. IBC was measured in a clinical study and the data were correlated to the in vitro model prediction. Conclusion: A triple quadrupole-based assay for IBC should broaden the monitoring of IBC for OCT1 inhibition in early clinical trials, generating the data needed to establish IBC as a valid biomarker.
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