Validated Biomarker Assay for the Analysis of Coproporphyrin I and Coproporphyrin III in Human Plasma
Coproporphyrin I (CP‐I) and Coproporphyrin III (CP‐III) are potential endogenous biomarkers for hepatic organic anion transporting polypeptide (OATP)1B1/1B3 function. We developed and validated a bioanalytical assay for monitoring these biomarkers to assess OATP1B1/1B3 inhibition in place of a standalone prospective clinical drug-drug interaction (DDI) study. Currently, investigational drugs that alter the pharmacokinetics of other medications are subject to additional testing to understand how to manage a DDI risk safely. By monitoring the effect of an investigation drug on the levels of these endogenous substrates of OATP1B1/1B3 in early clinical development, the potential need for a dedicated clinical DDI study could be avoided.
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