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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 is a Phase 1 study that has completed, run by Catabasis Pharmaceuticals. The registered enrollment target is 26 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04543370
The ClinicalTrials.gov registry entry for NCT04543370 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Catabasis Pharmaceuticals, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Edasalonexent 2000 mg TID is the first listed.
NCT04543370 reports 0 study locations.
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.
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