Trial Outcomes & Findings for Detection of miRNAs in HPA Axis Function in Healthy Subjects (NCT NCT04066647)

Results Overview

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).

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Baseline and 60 minutes

Results posted on

2020-07-17

Participant Flow

Participant milestones

Participant milestones
Measure	Dexamthesone Single arm study in which all healthy controls will receive 1 mg of dexamethasone intravenous (IV) injection. Dexamethasone 4mg: 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.
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexamethesone n=7 Participants Single arm study in which all healthy controls will receive 1 mg of dexamethasone intravenous (IV) injection. Dexamethasone 4mg: 1 mg IV dexamethasone will be pushed and miRNA levels will be checked at baseline just before injection and then at 60 minutes after injection.
Age, Categorical <=18 years	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=7 Participants
Age, Categorical >=65 years	0 Participants n=7 Participants
Age, Continuous	31 years n=7 Participants
Sex: Female, Male Female	5 Participants n=7 Participants
Sex: Female, Male Male	2 Participants n=7 Participants
Region of Enrollment United States	7 participants n=7 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Dexamethesone n=7 Participants Single arm study in which all healthy controls will receive 1 mg of dexamethasone intravenous (IV) injection. Dexamethasone 4mg: 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.
Change From Baseline (Time of Injection) miRNA Levels and 60 Minutes After Injection	0.939288216 percentage of change Standard Deviation 0.762951729

Adverse Events

Dexamethesone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kacey Haptonstall

Cedars Sinai Medical Center

Phone: 424-315-4489

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place