Trial Outcomes & Findings for Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids (NCT NCT03023891)

NCT ID: NCT03023891

Last Updated: 2020-06-04

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

25 participants

Primary outcome timeframe

baseline and within 4 and 8 hours after drug administration

Results posted on

2020-06-04

Participant Flow

25 participants signed consent, 5 did not show up for screening and 2 failed screening. 18 participants started the study.

Participant milestones

Participant milestones
Measure	Prednisone Each participant will received a single dose of oral 60 mg of prednisone Prednisone: Prednisone 60 mg tablet once
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prednisone n=18 Participants Each participant will received a single dose of oral 60 mg of prednisone Prednisone: Prednisone 60 mg tablet once
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Prednisone n=18 Participants Each participant will received a single dose of oral 60 mg of prednisone Prednisone: Prednisone 60 mg tablet once
White Blood Cell Counts Visit 1: baseline	5.26 x10^3 cells/mL Standard Deviation 0.92
White Blood Cell Counts Visit 2: 4 to 8 hours post prednisone	6.99 x10^3 cells/mL Standard Deviation 1.39

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Prednisone n=18 Participants Each participant will received a single dose of oral 60 mg of prednisone Prednisone: Prednisone 60 mg tablet once
Glucose Tolerance Test: Area Under the Curve (AUC) for Plasma Glucose Visit 1: baseline	13530.56 mg*min/dL Standard Deviation 2002.23
Glucose Tolerance Test: Area Under the Curve (AUC) for Plasma Glucose Visit 2: 4-8 hours post prednisone	20273.75 mg*min/dL Standard Deviation 3973.26

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Prednisone n=18 Participants Each participant will received a single dose of oral 60 mg of prednisone Prednisone: Prednisone 60 mg tablet once
Glucose Tolerance Test: Area Under the Curve (AUC) for Insulin Levels Visit 1: baseline	5415.87 μU*min/mL Standard Deviation 2344.63
Glucose Tolerance Test: Area Under the Curve (AUC) for Insulin Levels Visit 2: 4-8 hours post prednisone	5466.55 μU*min/mL Standard Deviation 2382.49

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Prednisone n=18 Participants Each participant will received a single dose of oral 60 mg of prednisone Prednisone: Prednisone 60 mg tablet once
Glucose Tolerance Test: Area Under the Curve (AUC) for C-peptide Levels Visit 1: baseline	493.89 ng*min/mL Standard Deviation 135.77
Glucose Tolerance Test: Area Under the Curve (AUC) for C-peptide Levels Visit 2: 4-8 hours post prednisone	449.41 ng*min/mL Standard Deviation 101.27

Adverse Events

Prednisone

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Prednisone n=18 participants at risk Each participant will received a single dose of oral 60 mg of prednisone Visit 1: Baseline Oral Glucose Tolerance Test (OGTT) and White Blood Count (WBC) count Visit 2: Prednisone 60 mg oral at 7am, OGGT and WBC count at 4 to 8 hours post drug Prednisone: Prednisone 60 mg tablet once
Gastrointestinal disorders Diarrhea	5.6% 1/18 • Number of events 1 • 2 days
General disorders Mild Dizziness	5.6% 1/18 • Number of events 1 • 2 days
General disorders Mild anxiety and hyperactivity	5.6% 1/18 • Number of events 1 • 2 days
General disorders Tiredness, Fatigue	5.6% 1/18 • Number of events 1 • 2 days
General disorders Dehydration	5.6% 1/18 • Number of events 1 • 2 days

Additional Information

Vivian Kawai

Vanderbilt University Medical Center

Phone: (615) 322-3304

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place