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AssigneeCorcept Therapeutics, Inc.
InventorsHazel Hunt, Joseph Custodio
Estimating the term…
Relacorilant is useful in the treatment of hypercortisolism and cancer. Many drugs useful in treating hypercortisolism or cancer are metabolized by CYP2C9 enzymes. The effects of concomitant administration of relacorilant and a CYP2C9 substrate are disclosed herein. Relacorilant potently inhibited CYP2C9 in an in vitro test, indicating that co-administration of relacorilant and a CYP2C9 substrate would be expected to increase the CYP2C9 substrate plasma exposure more than five-fold in vivo. Significant reductions in CYP2C9 substrate doses would be expected to be required when administered with relacorilant. Surprisingly, no such increase in plasma exposure was seen in human studies. Applicant discloses that relacorilant may be safely co-administered with unmodified doses of a CYP2C9 substrate such as, e.g., tolbutamide, glimepiride, and glipizide. Relacorilant and unmodified doses of CYP2C9 substrate such as tolbutamide, glimepiride, and glipizide may be co-administered to treat hypercortisolism, or may be co-administered to a cancer patient.
A method of treating a disorder selected from the group consisting of i) hypercortisolism, ii) a symptom associated with hypercortisolism in a patient suffering from hypercortisolism, iii) cancer, and iv) a symptom associated with cancer in a cancer patient, said treatment comprising combined administration of tolbutamide and relacorilant to a patient in need of treatment for said disorder, the method comprising administering to said patient in need of treatment for said disorder, without increased tolbutamide plasma exposure to said patient:
The concomitant use of relacorilant and the CYP2C9 substrate tolbutamide in a concomitant treatment, said concomitant treatment comprising concomitant administration of 350 milligrams (mg) of relacorilant and 500 mg of tolbutamide to a patient suffering from and in need of treatment for a disorder, for the treatment of said disorder without increased tolbutamide plasma exposure to said patient, wherein the disorder is selected from the group consisting of hypercortisolism, a symptom associated with hypercortisolism, cancer, and a symptom associated with cancer, wherein said concomitant administration of relacorilant and tolbutamide does not increase the tolbutamide AUCinf as compared to the tolbutamide AUCinf when administered in the absence of relacorilant, and reduces the tolbutamide Cmax by an amount that is about 31% of the tolbutamide Cmax when it is administered in the absence of relacorilant, whereby the patient is treated for the disorder.
Dependencies are inferred from the claim text.