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NCT03540836 · ClinicalTrials.gov registry record · Phase 1
A Study to Determine the Relative Bioavailability of Two New Relacorilant Capsule Variants
A Phase 1 study, sponsored by Corcept Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT03540836: Completed Phase 1 study, sponsored by Corcept Therapeutics.
NCT03540836 is a Phase 1 study that has completed, run by Corcept Therapeutics. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03540836, a Phase 1 study, has completed, sponsored by Corcept Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is an open-label, randomized, 3 treatment, 3-period, 6-sequence, crossover study conducted at a single study center to characterize the relative bioavailability of relacorilant administered as 3×100-mg softgel capsules (Treatment A), 3×100 mg hard-shell capsules (Treatment B), and 6×50-mg hard shell capsules (Treatment C/reference) in healthy, fasted, adult subjects. Eligible subjects will participate in 3 treatment periods. During each treatment period, subjects will receive a single 300-mg relacorilant dose. An equal number of subjects will be randomized to each of 6 sequences.
Primary Outcome
Ratio of population geometric means (GMR) of AUC0-tz for Test 1 (relacorilant 3×100-mg softgel capsules) and Reference (relacorilant 6×50-mg hard-shell capsules) and for Test 2 (relacorilant 3×100-mg hard-shell capsules) and Reference (relacorilant 6×50-mg hard-shell capsules)
Interventions
- DRUG Relacorilant (3x100 mg softgel capsules)
- DRUG Relacorilant (3x100 mg hard-shell capsules)
- DRUG Relacorilant (6x50mg hard-shell capsules)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-05-24 |
| Est. Completion | 2018-07-25 |
| Phase | Phase 1 |
What the finished NCT03540836 record still lists
NCT03540836 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 3 interventions - of which Relacorilant (3x100 mg softgel capsules) is the first listed.
NCT03540836 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03540836 about?
NCT03540836 is a clinical study titled "A Study to Determine the Relative Bioavailability of Two New Relacorilant Capsule Variants". This is an open-label, randomized, 3 treatment, 3-period, 6-sequence, crossover study conducted at a single study center to characterize the relative bioavailability of relacorilant administered as 3×100-mg softgel capsules (Treatment A), 3×100 mg hard-shell capsules (Treatment B), and 6×50-mg hard ...
What is the current status of trial NCT03540836?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2018-05-24. Estimated completion is 2018-07-25.
What interventions are being tested in trial NCT03540836?
The interventions under investigation include: Relacorilant (3x100 mg softgel capsules) (DRUG), Relacorilant (3x100 mg hard-shell capsules) (DRUG), Relacorilant (6x50mg hard-shell capsules) (DRUG).
Who is sponsoring clinical trial NCT03540836?
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 NCT03540836's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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