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Brief Title: A Study of Extending Relugolix Dosing Intervals Through Addition of Itraconazole or Ritonavir in Prostate Cancer Patients
Official Title: A Phase Ib Study of Extending Relugolix Dosing Intervals Through Addition of the CYP3A4 and Pg-P Inhibitor Itraconazole or Ritonavir in Prostate Cancer Patients
Study ID: NCT05679388
Brief Summary: Researchers leading this study hope to learn about the safety of combining the study drug relugolix with another study drug called itraconazole or ritonavir in prostate cancer. This study is for individuals who have advanced prostate cancer and plans to have medical castration (the use of medications or chemicals to lower hormone production in the testicles). Your participation in this research will last up to 1 month. The purpose of this research is to gather information on the safety and effectiveness of relugolix in combination with ritonavir or itraconazole. The goal of this research is to find out if combining two medications (relugolix and itraconazole or relugolix and ritonavir) could possibly lead to using less relugolix, which is an expensive drug.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Name: Walter Stadler
Affiliation: University of Chicago
Role: PRINCIPAL_INVESTIGATOR