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NCT04543370 · ClinicalTrials.gov registry record · Phase 1
Study of Edasalonexent With Midazolam and Deflazacort in Healthy Subjects
A Phase 1 study, sponsored by Catabasis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT04543370: Completed Phase 1 study, sponsored by Catabasis Pharmaceuticals.
NCT04543370 is a Phase 1 study that has completed, run by Catabasis Pharmaceuticals. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04543370, a Phase 1 study, has completed, sponsored by Catabasis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
Drug-drug interaction (DDI) and Cardiodynamic Evaluation Study To assess the effect of multiple oral doses of edasalonexent on the single-dose pharmacokinetics (PK) of midazolam (a cytochrome P450 \[CYP\]3A4 sensitive substrate) and of deflazacort (a CYP3A4 moderate sensitive substrate) in healthy adult subjects.
Interventions
- DRUG Edasalonexent 2000 mg TID
- DRUG Midazolam 2 MG/ML
- DRUG Deflazacort 36Mg Tab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2020-08-08 |
| Est. Completion | 2020-10-01 |
| Phase | Phase 1 |
What the finished NCT04543370 record still lists
NCT04543370 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 3 interventions - of which Edasalonexent 2000 mg TID is the first listed.
NCT04543370 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04543370 about?
NCT04543370 is a clinical study titled "Study of Edasalonexent With Midazolam and Deflazacort in Healthy Subjects". Drug-drug interaction (DDI) and Cardiodynamic Evaluation Study To assess the effect of multiple oral doses of edasalonexent on the single-dose pharmacokinetics (PK) of midazolam (a cytochrome P450 \[CYP\]3A4 sensitive substrate) and of deflazacort (a CYP3A4 moderate sensitive substrate) in healthy a...
What is the current status of trial NCT04543370?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2020-08-08. Estimated completion is 2020-10-01.
What interventions are being tested in trial NCT04543370?
The interventions under investigation include: Edasalonexent 2000 mg TID (DRUG), Midazolam 2 MG/ML (DRUG), Deflazacort 36Mg Tab (DRUG).
Who is sponsoring clinical trial NCT04543370?
This trial is sponsored by Catabasis Pharmaceuticals, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04543370's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 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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