Claims for Patent: 12,208,092

Summary for Patent: 12,208,092

Title:	Compositions and methods for administering paltusotine to patients with hepatic impairment
Abstract:	Provided are compositions and methods for administering paltusotine, or a pharmaceutically acceptable salt thereof, to a patient having hepatic impairment.
Inventor(s):	Lance GOULET, William Humphreys, Ajay Madan, Sha Luo
Assignee:	Crinetics Pharmaceuticals Inc
Application Number:	US18/615,512
Patent Claims:	1. A method comprising administering a therapeutically effective amount of paltusotine, or a pharmaceutically acceptable salt thereof, to a patient, wherein the patient has hepatic impairment, and wherein the therapeutically effective amount of paltusotine, or a pharmaceutically acceptable salt thereof, is the same amount that would be administered to a patient who does not have hepatic impairment, wherein the paltusotine is administered to the patient to treat acromegaly, carcinoid syndrome and/or neuroendocrine tumor. 2. A method comprising: (a) administering to a patient a therapeutically effective amount of paltusotine, or a pharmaceutically acceptable salt thereof; (b) subsequently determining that the patient has hepatic impairment; and (c) administering the same therapeutically effective amount of paltusotine, or a pharmaceutically acceptable salt thereof, to the patient without dose adjustment, wherein the paltusotine is administered to the patient to treat acromegaly, carcinoid syndrome and/or neuroendocrine tumor. 3. The method of claim 1, wherein the patient has mild, moderate, or severe hepatic impairment. 4. The method of claim 3, wherein the patient has mild hepatic impairment. 5. The method of claim 3, wherein the patient has moderate hepatic impairment. 6. The method of claim 3, wherein the patient has severe hepatic impairment. 7. The method of claim 1, wherein the patient has a Child-Pugh Score of 5-6, 7-9, or 10-15. 8. The method of claim 7, wherein the patient has a Child-Pugh Score of 4-5. 9. The method of claim 7, wherein the patient has a Child-Pugh Score of 6-8. 10. The method of claim 7, wherein the patient has a Child-Pugh Score of 10-15. 11. The method of claim 1, wherein the patient has acromegaly. 12. The method of claim 11, wherein the paltusotine, or a pharmaceutically acceptable salt thereof, is administered in an amount equivalent to about 40 mg of paltusotine free base. 13. The method of claim 11, wherein the paltusotine, or a pharmaceutically acceptable salt thereof, is administered in an amount equivalent to about 60 mg of paltusotine free base. 14. The method of claim 2, wherein the paltusotine, or a pharmaceutically acceptable salt thereof, is administered to the patient to treat acromegaly. 15. The method of claim 1, wherein the patient has carcinoid syndrome and/or NETs. 16. The method of claim 15, wherein the paltusotine, or a pharmaceutically acceptable salt thereof, is administered in an amount equivalent to about 40 mg of paltusotine free base. 17. The method of claim 15, wherein the paltusotine, or a pharmaceutically acceptable salt thereof, is administered in an amount equivalent to about 80 mg of paltusotine free base. 18. The method of claim 15, wherein the paltusotine, or a pharmaceutically acceptable salt thereof, is administered in an amount equivalent to about 120 mg of paltusotine free base. 19. The method of claim 2, wherein the paltusotine, or a pharmaceutically acceptable salt thereof, is administered to the patient to treat carcinoid syndrome and/or NETs. 20. The method of claim 1, wherein the paltusotine, or a pharmaceutically acceptable salt thereof, is administered daily. 21. The method of claim 1, wherein the paltusotine, or a pharmaceutically acceptable salt thereof, is administered once daily. 22. The method of claim 1, wherein the paltusotine, or a pharmaceutically acceptable salt thereof, is administered orally. 23. The method of claim 1, wherein the paltusotine, or a pharmaceutically acceptable salt thereof, is administered in one or more oral dosage forms. 24. The method of claim 23, wherein the oral dosage form is a tablet. 25. The method of claim 1, wherein the paltusotine, or a pharmaceutically acceptable salt thereof, is a hydrochloride salt of paltusotine. 26. The method of claim 25, wherein the hydrochloride salt of paltusotine is amorphous. 27. The method of claim 1, wherein the patient with hepatic impairment has equivalent exposure of paltusotine free base as in a patient with normal hepatic function who is administered the same amount of paltusotine, or a pharmaceutically acceptable salt thereof.