NCT03023891

Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids

Completed Phase 1 Results posted Last updated 4 June 2020

What this trial tests

Phase 1 trial testing Prednisone in Glucocorticoids Toxicity in 25 participants. Completed in 31 December 2019.

Timeline

15 February 2017

Primary endpoint
10 January 2019

31 December 2019

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	25
Start date	15 February 2017
Primary completion	10 January 2019
Estimated completion	31 December 2019
Sites	1 location across United States

Drugs / interventions tested

• Prednisone (prednisone) — full drug profile →

Conditions studied

• Glucocorticoids Toxicity — all drugs for Glucocorticoids Toxicity →
• Glucose Intolerance — all drugs for Glucose Intolerance →

Sponsor

Vanderbilt University Medical Center

Who can join

Adults 18 to 45, any sex, with Glucocorticoids Toxicity or Glucose Intolerance. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

White Blood Cell Counts Primary · baseline and within 4 and 8 hours after drug administration

White Blood Count at baseline (Visit 1) and within 4 to 8 hours after drug administration (Visit 2)

Visit 1: baseline

Group	Value	95% CI
Prednisone	5.26	± 0.92

Visit 2: 4 to 8 hours post prednisone

Group	Value	95% CI
Prednisone	6.99	± 1.39

Glucose Tolerance Test: Area Under the Curve (AUC) for Plasma Glucose Primary · baseline and 4-8 hours after drug administration

AUC for plasma glucose during glucose tolerance test at baseline and 4-8 hours after drug administration. Plasma glucose levels were measured at 0, 10, 20, 30, 60, 90 and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration (Visit 2)

Visit 1: baseline

Group	Value	95% CI
Prednisone	13530.56	± 2002.23

Visit 2: 4-8 hours post prednisone

Group	Value	95% CI
Prednisone	20273.75	± 3973.26

Glucose Tolerance Test: Area Under the Curve (AUC) for Insulin Levels Primary · baseline and 4-8 hours after drug administration

AUC for insulin levels during glucose tolerance test at baseline and 4-8 hours after prednisone. Insulin levels were measured at 0, 10, 20, 30, 60, 90 and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration administration (Visit 2).

Visit 1: baseline

Group	Value	95% CI
Prednisone	5415.87	± 2344.63

Visit 2: 4-8 hours post prednisone

Group	Value	95% CI
Prednisone	5466.55	± 2382.49

Glucose Tolerance Test: Area Under the Curve (AUC) for C-peptide Levels Primary · baseline and 4-8 hours after drug administration

AUC for C-peptide during glucose tolerance test at baseline and 4-8 hours after prednisone. C-peptide levels were measured at 0, 10, 20, 30, 60, 90, and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration (Visit 2)

Visit 1: baseline

Group	Value	95% CI
Prednisone	493.89	± 135.77

Visit 2: 4-8 hours post prednisone

Group	Value	95% CI
Prednisone	449.41	± 101.27

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Prednisone

Serious: 0/18 (0%)

Deaths: 0/18

Other adverse events (5 terms — click to expand)

Reaction	System	Prednisone
Diarrhea	Gastrointestinal disorders	—
Mild Dizziness	General disorders	—
Mild anxiety and hyperactivity	General disorders	—
Tiredness, Fatigue	General disorders	—
Dehydration	General disorders	—

Data from ClinicalTrials.gov NCT03023891 adverse events section.

Sponsor's own description

This study evaluates the effect of acute administration of oral prednisone in white blood cells counts and glucose tolerance and the relationship of these measures with changes in gene expression in healthy volunteers. White blood cells counts, glucose tolerance and gene expression will be study before and after prednisone administration.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.