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NCT05679388 · ClinicalTrials.gov registry record · Phase 1
A Study of Extending Relugolix Dosing Intervals Through Addition of Itraconazole or Ritonavir in Prostate Cancer Patients
A Phase 1 study, sponsored by University of Chicago.
- Terminated
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT05679388: Clinical Trial Phase 1 study, sponsored by University of Chicago.
NCT05679388 is a Phase 1 study that was terminated before completion, run by University of Chicago. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05679388, a Phase 1 study, was terminated before completion, sponsored by University of Chicago.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study 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.
Primary Outcome
To determine whether the addition of itraconazole and ritonavir to relugolix sustains testosterone suppression as assessed by participant testosterone levels.
Interventions
- DRUG Itraconazole
- DRUG Ritonavir
- DRUG Relugolix Pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-02-13 |
| Est. Completion | 2024-08-05 |
| Phase | Phase 1 |
Why NCT05679388 stopped before completion
NCT05679388 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Itraconazole is the first listed.
NCT05679388 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05679388 about?
NCT05679388 is a clinical study titled "A Study of Extending Relugolix Dosing Intervals Through Addition of Itraconazole or Ritonavir in Prostate Cancer Patients". 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 medication...
What is the current status of trial NCT05679388?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2023-02-13. Estimated completion is 2024-08-05.
What interventions are being tested in trial NCT05679388?
The interventions under investigation include: Itraconazole (DRUG), Ritonavir (DRUG), Relugolix Pill (DRUG).
Who is sponsoring clinical trial NCT05679388?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05679388's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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