Patent ID: 8883410

Claim:
A method of determining the relative metabolic stability profile of a test agent due to semicarbazide-sensitive amine oxidase (SSAO) catalyzed metabolism in recombinant cultured cells expressing full-length SSAO and in a biological sample comprising SSAO, wherein the test agent is a drug candidate and the metabolic stability of the test agent due to SSAO catalyzed metabolism is unknown, the method comprising: a) determining the metabolic stability of the test agent in the presence of recombinant cultured cells expressing full-length SSAO; by: i) adding the test agent to the recombinant cultured cells; ii) incubating the test agent with the recombinant cultured cells for a predetermined period of time; iii) measuring the amount of the test agent remaining in the presence of the recombinant cultured cells at the predetermined period of time; and iv) comparing the amount of the test agent remaining in the presence of the recombinant cultured cells at the predetermined period of time to a control to determine the metabolic stability of the test agent in the presence of recombinant cultured cells expressing full-length SSAO; b) determining the metabolic stability of the test agent in the presence of a biological sample comprising SSAO by: i) adding the test agent to the biological sample; ii) incubating the test agent with the biological sample for a predetermined period of time; iii) measuring the amount of the test agent remaining in the presence of the biological sample at the predetermined period of time; and iv) comparing the amount of the test agent remaining in the presence of the biological sample at the predetermined period of time to a control to determine the metabolic stability of the test agent in the presence of a biological sample comprising SSAO; and c) comparing the metabolic stability of the test agent in the presence of recombinant cultured cells expressing full-length SSAO to the metabolic stability of the test agent in the presence of a biological sample comprising SSAO to determine the relative metabolic stability profile of the test agent.