Biomarker to measure drug efficacy in enteropathic disease

Details Biomarker to measure drug efficacy in enteropathic disease Biomarker to measure drug efficacy in enteropathic disease

G - Physics

01

N

G01N 33/48 (2006.01) A61K 49/00 (2006.01)

Patent

CA 2698359

The response of a patient with an enteropathic disease to therapy, particularly a candidate therapy in a clinical trial setting, is assessed by detecting the ability of the patient to metabolize an orally administered CYP3A substrate. The CYP3A metabolism may be monitored in a variety of ways. Conveniently, the appearance of a metabolite of the CYP3A substrate is detected in a patient sample over a period of time following oral administration, e.g. in urine, plasma, breath, saliva, etc. The CYP3A substrate is optionally labeled, e.g. with an isotopic, fluorescent, etc. label.

Selon la présente invention, la réponse thérapeutique d'un patient souffrant d'une entéropathie, en particulier à une thérapie candidate lors de la mise au point d'un essai clinique, est évaluée par la détection de la capacité du patient de métaboliser un substrat de CYP3A administré par voie orale. Le métabolisme du CYP3A peut être suivi de plusieurs manières. De façon pratique, l'apparition d'un métabolite du substrat de CYP3A est détecté dans un échantillon de patient durant une période de temps qui suit l'administration orale, notamment dans l'urine, le plasma, les gaz respiratoires, la salive, entre autres. Le substrat de CYP3A est éventuellement marqué,notamment avec un marqueur isotopique, fluorescent, entre autres.

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