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NCT03512548 · ClinicalTrials.gov registry record · Phase 1
Study in Healthy Subjects to Determine the Effect of an Inhibitor on Exposure to Relacorilant and Its Metabolites
A Phase 1 study, sponsored by Corcept Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT03512548 is a Phase 1 study that has completed, run by Corcept Therapeutics. The registered enrollment target is 52 participants.
The verdict
NCT03512548, a Phase 1 study, has completed, sponsored by Corcept Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
This is an open label, single sequence, crossover study. In Part 1, eligible subjects will participate in 3 treatment periods, in which they will receive the following treatments in turn: 1) In Period 1, a single 350-mg dose of relacorilant administered alone, 2) In Period 2, once daily 200-mg doses of itraconazole administered for 3 days; 3) In Period 3, single 350-mg dose of relacorilant administered with a concomitant 200-mg dose of itraconazole and continued once daily 200-mg doses of itraconazole for three additional days. If Part 2 is conducted, eligible subjects will participate in 2 treatment periods, in which they will receive the following treatments in turn: 1) In Period A, once daily 300-mg doses of relacorilant alone for 10 days; 2) In Period B, once daily 300-mg doses of relacorilant in combination with once daily 200-mg doses of itraconazole for 10 days.
Interventions
- DRUG Itraconazole
- DRUG Relacorilant 350mg
- DRUG Relacorilant 300mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2018-04-10 |
| Est. Completion | 2019-08-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03512548
The ClinicalTrials.gov registry entry for NCT03512548 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Corcept Therapeutics, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Itraconazole is the first listed.
NCT03512548 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03512548 about?
NCT03512548 is a clinical study titled "Study in Healthy Subjects to Determine the Effect of an Inhibitor on Exposure to Relacorilant and Its Metabolites". This is an open label, single sequence, crossover study. In Part 1, eligible subjects will participate in 3 treatment periods, in which they will receive the following treatments in turn: 1) In Period 1, a single 350-mg dose of relacorilant administered alone, 2) In Period 2, once daily 200-mg doses...
What is the current status of trial NCT03512548?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2018-04-10. Estimated completion is 2019-08-23.
What interventions are being tested in trial NCT03512548?
The interventions under investigation include: Itraconazole (DRUG), Relacorilant 350mg (DRUG), Relacorilant 300mg (DRUG).
Who is sponsoring clinical trial NCT03512548?
This trial is sponsored by Corcept Therapeutics, which has 54 total clinical trials registered on ClinicalTrials.gov.
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