A Study of Extending Relugolix Dosing Intervals Through Addition of Itraconazole or Ritonavir in Prostate Cancer Patients

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT05679388
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Relugolix Pill — DRUG
    A medication used to treat prostate cancer. Relugolix comes as a tablet to take by mouth. It is usually taken with or without food once daily.
  • Ritonavir — DRUG
    HIV antiviral It can treat HIV infection, which causes AIDS. It does not cure HIV or AIDS, but combinations of drugs may slow the progress of the disease and prolong life.
  • Itraconazole — DRUG
    A drug used to treat fungal infections.

Study Details

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.

Key Dates

Start date
Feb 13, 2023
Status verified
Oct 2023
Primary completion
Aug 5, 2024
Completion
Aug 5, 2024

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Study Group 1
    All study participants will receive a starting dose of relugolix (360 mg in the form of three 120 mg tablets) on Day 1 of the 29-day drug administration period. After Day 1, you will receive relugolix on its own or relugolix combined with another medication called itraconazole or ritonavir. The combination of medications you receive, the dosage for each medication, and when you take each medication will be based on the study group you are enrolled in. Study Group 1 will receive: * Relugolix (360 mg) on Day 1 * Relugolix (120 mg) on Days 2-7
  • Experimental: Study Group 2a
    All study participants will receive a starting dose of relugolix (360 mg in the form of three 120 mg tablets) on Day 1 of the 29-day drug administration period. After Day 1, you will receive relugolix on its own or relugolix combined with another medication called itraconazole or ritonavir. The combination of medications you receive, the dosage for each medication, and when you take each medication will be based on the study group you are enrolled in. Study Group 2a will receive: * Relugolix (360 mg) on Day 1 * Relugolix (120 mg) on Days 2-7 * Itraconazole (200 mg) on Days 1-14
  • Experimental: Study Group 2b
    All study participants will receive a starting dose of relugolix (360 mg in the form of three 120 mg tablets) on Day 1 of the 29-day drug administration period. After Day 1, you will receive relugolix on its own or relugolix combined with another medication called itraconazole or ritonavir. The combination of medications you receive, the dosage for each medication, and when you take each medication will be based on the study group you are enrolled in. Study Group 2b will receive: * Relugolix (360 mg) on Day 1 * Relugolix (120 mg) on Days 2-7 * Ritonavir (100 mg tablets taken by mouth) on Days 1-14
  • Experimental: Study Group 3a
    All study participants will receive a starting dose of relugolix (360 mg in the form of three 120 mg tablets) on Day 1 of the 29-day drug administration period. After Day 1, you will receive relugolix on its own or relugolix combined with another medication called itraconazole or ritonavir. The combination of medications you receive, the dosage for each medication, and when you take each medication will be based on the study group you are enrolled in. Study Group 3a will receive: * Relugolix (360 mg) on Day 1 * Relugolix (120 mg) on Days 2-4 * Itraconazole (200 mg tablets taken by mouth) on Days 1-14
  • Experimental: Study Group 3b
    All study participants will receive a starting dose of relugolix (360 mg in the form of three 120 mg tablets) on Day 1 of the 29-day drug administration period. After Day 1, you will receive relugolix on its own or relugolix combined with another medication called itraconazole or ritonavir. The combination of medications you receive, the dosage for each medication, and when you take each medication will be based on the study group you are enrolled in. Study Group 3b will receive: * Relugolix (360 mg) on Day 1 * Relugolix (120 mg) on Days 2-4 * Ritonavir (100 mg) on Days 1-14

Primary Outcome Measure

Testosterone Suppression of Participants as Assessed by Testosterone Levels [ Time Frame: 1 month post start of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Chicago Comprehensive Cancer CenterChicagoIllinois60453-

Find similar trials in Chicago, IL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of Chicago Comprehensive Cancer Center· Chicago, IL

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