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NCT03457597 · ClinicalTrials.gov registry record · Phase 1
Study in Healthy Subjects to Determine the Effect of Relacorilant on Exposure to Probe Substrates for Cytochrome P450s
A Phase 1 study, sponsored by Corcept Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT03457597: Completed Phase 1 study, sponsored by Corcept Therapeutics.
NCT03457597 is a Phase 1 study that has completed, run by Corcept Therapeutics. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03457597, a Phase 1 study, has completed, sponsored by Corcept Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
This is an open-label, single-sequence, 3-period crossover study conducted in healthy subjects. Eligible subjects will participate in a single treatment period, in which they will receive the following treatments: Day 1, single doses of midazolam and metoprolol; Day 2, single doses of pioglitazone, tolbutamide, and omeprazole; Days 5 to 17, daily doses of relacorilant; Day 14, single doses of midazolam and metoprolol (with relacorilant); and, Day 15, single doses of pioglitazone, tolbutamide, and omeprazole (with relacorilant).
Primary Outcome
Ratio of population geometric means (GMR) for Reference Day (following a single dose with each probe substrate given within a cocktail of probe substrates) and Test Day (following the same dose given to subjects after 10 or 11 days of daily dosing with relacorilant) areas under plasma concentration-time curve up to the last quantifiable sample (AUC0-tz)
Interventions
- DRUG Omeprazole
- DRUG Tolbutamide
- DRUG Metoprolol tartrate
- DRUG Pioglitazone hydrochloride
- DRUG Midazolam hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2018-03-06 |
| Est. Completion | 2018-04-28 |
| Phase | Phase 1 |
What the finished NCT03457597 record still lists
NCT03457597 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 5 interventions - of which Omeprazole is the first listed.
NCT03457597 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03457597 about?
NCT03457597 is a clinical study titled "Study in Healthy Subjects to Determine the Effect of Relacorilant on Exposure to Probe Substrates for Cytochrome P450s". This is an open-label, single-sequence, 3-period crossover study conducted in healthy subjects. Eligible subjects will participate in a single treatment period, in which they will receive the following treatments: Day 1, single doses of midazolam and metoprolol; Day 2, single doses of pioglitazone, ...
What is the current status of trial NCT03457597?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2018-03-06. Estimated completion is 2018-04-28.
What interventions are being tested in trial NCT03457597?
The interventions under investigation include: Omeprazole (DRUG), Tolbutamide (DRUG), Metoprolol tartrate (DRUG), Pioglitazone hydrochloride (DRUG), Midazolam hydrochloride (DRUG).
Who is sponsoring clinical trial NCT03457597?
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 NCT03457597's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 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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