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NCT04066647 · ClinicalTrials.gov registry record · Phase 1
Detection of miRNAs in HPA Axis Function in Healthy Subjects
A Phase 1 study, sponsored by Cedars-Sinai Medical Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT04066647 is a Phase 1 study that was terminated before completion, run by Cedars-Sinai Medical Center. The registered enrollment target is 7 participants.
The verdict
NCT04066647, a Phase 1 study, was terminated before completion, sponsored by Cedars-Sinai Medical Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
The proposed study will test dexamethasone effect on miRNA profile in healthy humans. As our data indicate that miRNA levels change over time, the investigators will study the time course of miRNA response to 1 mg IV dexamethasone within 60 minutes after injection. Dexamethasone is used routinely in human subjects for the treatment of inflammatory conditions and as a diagnostic tool in the evaluation of excess cortisol secretion (Cushing's syndrome). For the latter, 1 mg dexamethasone is given orally at midnight. Oral formula absorption in the gut can range from 20 to 60 minutes due to the presence of food and other factors. IV administration will bypass this variability and ensure an accurate and reproducible time-course study. The investigators will compare miRNA expression before and after dexamethasone treatment. The investigators will follow miRNA expression dynamics over a 1-hour time course to identify peak expression levels and to correlate miRNA expression with circulating dexamethasone levels. Dexamethasone and miRNA levels will be checked at baseline just before injection and then at 15, 30, 45, and 60 minutes after injection. Dexamethasone level is taken to verify treatment and to correlate it with miRNA expression.
Interventions
- DRUG Dexamethasone 4mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2019-05-09 |
| Est. Completion | 2019-07-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04066647
The ClinicalTrials.gov registry entry for NCT04066647 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Dexamethasone 4mg is the first listed.
NCT04066647 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04066647 about?
NCT04066647 is a clinical study titled "Detection of miRNAs in HPA Axis Function in Healthy Subjects". The proposed study will test dexamethasone effect on miRNA profile in healthy humans. As our data indicate that miRNA levels change over time, the investigators will study the time course of miRNA response to 1 mg IV dexamethasone within 60 minutes after injection. Dexamethasone is used routinely in...
What is the current status of trial NCT04066647?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2019-05-09. Estimated completion is 2019-07-24.
What interventions are being tested in trial NCT04066647?
The interventions under investigation include: Dexamethasone 4mg (DRUG).
Who is sponsoring clinical trial NCT04066647?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
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