Dexamethasone Effect on miRNA Profile in Healthy HumansPhase 1/2NCT04066647

Detection of miRNAs in HPA Axis Function in Healthy Subjects

A Phase 1/2 study testing Dexamethasone 4mg in people with Dexamethasone Effect on miRNA Profile in Healthy Humans, run by Cedars-Sinai Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Dexamethasone Effect on miRNA Profile in Healthy Humans
What is being tested?: Dexamethasone 4mg
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: 9 May 2019to 24 Jul 2019
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Adults age ≥ 18

Who cannot join

Pregnancy
Presence of a disease that affects HPA axis function
Current use of medications that affect cortisol secretion, such as opioid pain medication, anti-fungal agents, anti-epileptic agents, and glucocorticoids, including hydrocortisone, prednisone, dexamethasone, steroid-containing inhalers, and steroid injected into the joints
History of adverse event related to use of glucocorticoids

Trial locations and contacts

1 site in 1 country.

United States1 site

Cedars-Sinai Medical Center
Los Angeles, California, 90048

Other trials in United States

About this study

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.

Conditions: Dexamethasone Effect on miRNA Profile in Healthy Humans
Being tested: Dexamethasone 4mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dexamethasone 4mgDrug
1 mg IV dexamethasone will be pushed and miRNA levels will be checked at baseline just before injection and then at 15, 30, 45, and 60 minutes after injection.

Study groups in NCT04066647
Study group	Role	What they receive
Dexamthesone	Experimental	Single arm study in which all healthy controls will receive 1 mg of dexamethasone intravenous (IV) injection. Receives: Drug: Dexamethasone 4mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline (Time of Injection) miRNA Levels and 60 Minutes After Injection
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).
Measured: Baseline and 60 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 May 201924 Jul 2019

First posted26 Aug 2019
Study start9 May 2019
Primary completion24 Jul 2019
Study completion24 Jul 2019

Why it stopped: Interim analysis shows results opposite of hypothesized.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Dexamethasone Effect on miRNA Profile in Healthy HumansStudies of the same condition, open and under way.
More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04066647
Sponsor's protocol ID: Pro57715
Status last verified: Jul 2020
First submitted: 24 Jul 2019
Last updated: 17 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Yamamoto M, Ben-Shlomo A, Kameda H, Fukuoka H, Deng N, Ding Y, Melmed S. Somatostatin receptor subtype 5 modifies hypothalamic-pituitary-adrenal axis stress function. JCI Insight. 2018 Oct 4;3(19):e122932. doi: 10.1172/jci.insight.122932.
PubMed 30282821
Altuvia Y, Landgraf P, Lithwick G, Elefant N, Pfeffer S, Aravin A, Brownstein MJ, Tuschl T, Margalit H. Clustering and conservation patterns of human microRNAs. Nucleic Acids Res. 2005 May 12;33(8):2697-706. doi: 10.1093/nar/gki567. Print 2005.
PubMed 15891114

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Detection of miRNAs in HPA Axis Function in Healthy Subjects
ClinicalTrials.gov ID: NCT04066647
Acronym / sponsor ID: Pro57715
Conditions: Dexamethasone Effect on miRNA Profile in Healthy Humans
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Interim analysis shows results opposite of hypothesized.
Enrolment: 7 participants (actual)
Lead sponsor: Cedars-Sinai Medical CenterUniversity, hospital or other
Study start: 9 May 2019 (actual)
Primary completion: 24 Jul 2019 (actual)
Study completion: 24 Jul 2019 (actual)
First posted: 26 Aug 2019 (actual)
Results: Posted 17 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Dexamthesone	Experimental	Drug: Dexamethasone 4mgSingle arm study in which all healthy controls will receive 1 mg of dexamethasone intravenous (IV) injection.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adults age ≥ 18

Key exclusion criteria (4 listed)

Pregnancy
Presence of a disease that affects HPA axis function
Current use of medications that affect cortisol secretion, such as opioid pain medication, anti-fungal agents, anti-epileptic agents, and glucocorticoids, including hydrocortisone, prednisone, dexamethasone, steroid-containing inhalers, and steroid injected into the joints
History of adverse event related to use of glucocorticoids

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dexamethasone 4mg1 mg IV dexamethasone will be pushed and miRNA levels will be checked at baseline just before injection and then at 15, 30, 45, and 60 minutes after injection.	Drug	Dexamthesone

Primary outcome

Change From Baseline (Time of Injection) miRNA Levels and 60 Minutes After Injection
Time frame: Baseline and 60 minutes
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).

Results and safety

Results posted to the registry on 17 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dexamthesone	7	7

Primary outcome: Change From Baseline (Time of Injection) miRNA Levels and 60 Minutes After Injection

Time frame: Baseline and 60 minutes. Mean (Standard Deviation). Unit: percentage of change

Measure	Dexamethesone n = 7
Value	0.939288216 (0.762951729)

Dexamethesone: Mean Difference (Final Values): 0.93928821, p = 0.9, t-test, 2 sided

Adverse events

Time frame: 2.5 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dexamethesone	0 of 7 (0%)	0 of 7 (0%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30282821Yamamoto M, Ben-Shlomo A, Kameda H, Fukuoka H, Deng N, Ding Y, Melmed S. Somatostatin receptor subtype 5 modifies hypothalamic-pituitary-adrenal axis stress function. JCI Insight. 2018 Oct 4;3(19):e122932. doi: 10.1172/jci.insight.122932.
Background: PubMed 15891114Altuvia Y, Landgraf P, Lithwick G, Elefant N, Pfeffer S, Aravin A, Brownstein MJ, Tuschl T, Margalit H. Clustering and conservation patterns of human microRNAs. Nucleic Acids Res. 2005 May 12;33(8):2697-706. doi: 10.1093/nar/gki567. Print 2005.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anat Benshlomo, MD principal investigator

Cedars-Sinai Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Dexamethasone 4mg in people with Dexamethasone Effect on miRNA Profile in Healthy Humans, run by Cedars-Sinai Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline (Time of Injection) miRNA Levels and 60 Minutes After Injection (time frame: Baseline and 60 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04066647, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.