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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: Completed Phase 1 study, sponsored by Corcept Therapeutics.
NCT03512548 is a Phase 1 study that has completed, run by Corcept Therapeutics. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Ratio of population geometric means (GMR) for Reference (following oral administration of relacorilant alone) and Test (following the same dose given to subjects concomitantly with itraconazole) areas under plasma concentration-time curve up to the last quantifiable sample (AUC0-tz)
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 |
What the finished NCT03512548 record still lists
NCT03512548 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 3 interventions - of which Itraconazole is the first listed.
NCT03512548 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03512548's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 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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