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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: Clinical Trial Phase 1 study, sponsored by Cedars-Sinai Medical Center.
NCT04066647 is a Phase 1 study that was terminated before completion, run by Cedars-Sinai Medical Center. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The change of miRNA levels in blood between time of injection (baseline) and 60 minutes after injection. Expressed as miRx ratio: miR expression level normalized to miR7-2-1 expression level and divided by miRx expression at baseline (T0).
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 |
Why NCT04066647 stopped before completion
NCT04066647 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Dexamethasone 4mg is the first listed.
NCT04066647 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04066647's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 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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