Trial Outcomes & Findings for Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects (NCT NCT06649409)
NCT ID: NCT06649409
Last Updated: 2025-09-11
Results Overview
Amounts of Na and K were calculated by multiplying the respective concentration by the volume of urine for each collection interval. The considered timepoints were: Day 1: 24-9 h and 9-0 h predose of vamorolone/eplerenone; Day 2: 0-2 h, 2-4 h, 4-6 h, 6-8 h, 8-10 h, 10-12 h, 12-14 h, 14-16 h, 16-24 h postdose vamorolone/eplerenone or corresponding timepoint for negative control arm with fludrocortisone administrations (no treatment) Day 3: 24-32 h, 32-40 h, 40-48 h postdose vamorolone/eplerenone or corresponding timepoint for negative control arm with fludrocortisone administrations (no treatment) The individual Na/K ratio was then calculated for each urine collection interval using the amounts of Na and K. The corresponding logarithm of the Na/K ratio was determined. To avoid negative values, the ratio was multiplied by 10 before transformation, i.e., log10(10\*Na/K).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Day 1, Day 2 and Day 3
Results posted on
2025-09-11
Participant Flow
Participant milestones
| Measure |
Study Arm 1 (Test Arm)Vamorolone
single oral dose of vamorolone 20 mg/kg on day 2
\+ Fludrocortisone Challenge Day 1: 1 mg single dose at 9 h predose vamorolone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone dosing.
Vamorolone: vamorolone 20 mg/kg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 2 (Positive Control Arm): Eplerenone
single oral dose of eplerenone 200 mg on day 2
\+ Fludrocortisone challenge Day 1: 1 mg single dose at 9 h predose eplerenone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose eplerenone dosing.
Eplerenone: Eplerenone 200 mg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 3 (Negative Control Arm): no Treatment
Fludrocortisone challenge only Day 1: 1 mg single dose at 9 h predose vamorolone/eplerenone\* dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone/eplerenone\* dosing.
\*or corresponding timepoint for negative control arm
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Study Arm 1 (Test Arm)Vamorolone
n=10 Participants
single oral dose of vamorolone 20 mg/kg on day 2
\+ Fludrocortisone Challenge Day 1: 1 mg single dose at 9 h predose vamorolone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone dosing.
Vamorolone: vamorolone 20 mg/kg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 2 (Positive Control Arm): Eplerenone
n=10 Participants
single oral dose of eplerenone 200 mg on day 2
\+ Fludrocortisone challenge Day 1: 1 mg single dose at 9 h predose eplerenone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose eplerenone dosing.
Eplerenone: Eplerenone 200 mg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 3 (Negative Control Arm): no Treatment
n=10 Participants
Fludrocortisone challenge only Day 1: 1 mg single dose at 9 h predose vamorolone/eplerenone\* dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone/eplerenone\* dosing.
\*or corresponding timepoint for negative control arm
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.7 years
STANDARD_DEVIATION 9.91 • n=99 Participants
|
45.3 years
STANDARD_DEVIATION 10.60 • n=107 Participants
|
35.6 years
STANDARD_DEVIATION 7.86 • n=206 Participants
|
40.9 years
STANDARD_DEVIATION 10.06 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
Germany
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
10 participants
n=206 Participants
|
30 participants
n=7 Participants
|
|
BMI
|
24.69 kg/m2
STANDARD_DEVIATION 3.211 • n=99 Participants
|
26.73 kg/m2
STANDARD_DEVIATION 2.200 • n=107 Participants
|
24.91 kg/m2
STANDARD_DEVIATION 2.295 • n=206 Participants
|
25.44 kg/m2
STANDARD_DEVIATION 2.683 • n=7 Participants
|
|
Weight
|
80.56 kg
STANDARD_DEVIATION 13.828 • n=99 Participants
|
85.45 kg
STANDARD_DEVIATION 13.115 • n=107 Participants
|
78.95 kg
STANDARD_DEVIATION 10.581 • n=206 Participants
|
81.65 kg
STANDARD_DEVIATION 12.465 • n=7 Participants
|
|
Height
|
180.2 cm
STANDARD_DEVIATION 7.44 • n=99 Participants
|
178.3 cm
STANDARD_DEVIATION 6.84 • n=107 Participants
|
177.9 cm
STANDARD_DEVIATION 7.08 • n=206 Participants
|
178.8 cm
STANDARD_DEVIATION 6.95 • n=7 Participants
|
PRIMARY outcome
Timeframe: Day 1, Day 2 and Day 3Population: This set is a subset of the Safety Set and includes all subjects who completed the study without any findings/events likely affecting Pharmacodynamic (PD).
Amounts of Na and K were calculated by multiplying the respective concentration by the volume of urine for each collection interval. The considered timepoints were: Day 1: 24-9 h and 9-0 h predose of vamorolone/eplerenone; Day 2: 0-2 h, 2-4 h, 4-6 h, 6-8 h, 8-10 h, 10-12 h, 12-14 h, 14-16 h, 16-24 h postdose vamorolone/eplerenone or corresponding timepoint for negative control arm with fludrocortisone administrations (no treatment) Day 3: 24-32 h, 32-40 h, 40-48 h postdose vamorolone/eplerenone or corresponding timepoint for negative control arm with fludrocortisone administrations (no treatment) The individual Na/K ratio was then calculated for each urine collection interval using the amounts of Na and K. The corresponding logarithm of the Na/K ratio was determined. To avoid negative values, the ratio was multiplied by 10 before transformation, i.e., log10(10\*Na/K).
Outcome measures
| Measure |
Study Arm 1 (Test Arm)Vamorolone
n=10 Participants
single oral dose of vamorolone 20 mg/kg on day 2
\+ Fludrocortisone Challenge Day 1: 1 mg single dose at 9 h predose vamorolone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone dosing.
Vamorolone: vamorolone 20 mg/kg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 2 (Positive Control Arm): Eplerenone
n=10 Participants
single oral dose of eplerenone 200 mg on day 2
\+ Fludrocortisone challenge Day 1: 1 mg single dose at 9 h predose eplerenone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose eplerenone dosing.
Eplerenone: Eplerenone 200 mg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 3 (Negative Control Arm): no Treatment
n=10 Participants
Fludrocortisone challenge only Day 1: 1 mg single dose at 9 h predose vamorolone/eplerenone\* dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone/eplerenone\* dosing.
\*or corresponding timepoint for negative control arm
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
|---|---|---|---|
|
Determination of the Ratio of Sodium to Potassium (Na/K) in Urine
Day 1; 24-9h predose (Baseline)
|
1.12929 log10(10*Na/K)
Standard Deviation 1.090602
|
0.98207 log10(10*Na/K)
Standard Deviation 1.290309
|
1.04238 log10(10*Na/K)
Standard Deviation 1.407236
|
|
Determination of the Ratio of Sodium to Potassium (Na/K) in Urine
Day 1; 9-0h predose
|
0.54902 log10(10*Na/K)
Standard Deviation 1.483174
|
0.55352 log10(10*Na/K)
Standard Deviation 1.508765
|
0.45720 log10(10*Na/K)
Standard Deviation 1.788948
|
|
Determination of the Ratio of Sodium to Potassium (Na/K) in Urine
Day 2; 0-2h postdose
|
0.57742 log10(10*Na/K)
Standard Deviation 1.168846
|
0.49927 log10(10*Na/K)
Standard Deviation 1.565160
|
0.53698 log10(10*Na/K)
Standard Deviation 1.351042
|
|
Determination of the Ratio of Sodium to Potassium (Na/K) in Urine
Day 2; 2-4h postdose
|
0.61770 log10(10*Na/K)
Standard Deviation 1.506227
|
0.68844 log10(10*Na/K)
Standard Deviation 1.363715
|
0.47736 log10(10*Na/K)
Standard Deviation 1.297863
|
|
Determination of the Ratio of Sodium to Potassium (Na/K) in Urine
Day 2; 4-6h postdose
|
0.93496 log10(10*Na/K)
Standard Deviation 1.227122
|
0.98531 log10(10*Na/K)
Standard Deviation 1.198851
|
0.20520 log10(10*Na/K)
Standard Deviation 1.715714
|
|
Determination of the Ratio of Sodium to Potassium (Na/K) in Urine
Day 2; 6-8h postdose
|
0.59716 log10(10*Na/K)
Standard Deviation 1.849719
|
1.12174 log10(10*Na/K)
Standard Deviation 1.150301
|
0.31908 log10(10*Na/K)
Standard Deviation 1.543390
|
|
Determination of the Ratio of Sodium to Potassium (Na/K) in Urine
Day 2; 8-10h postdose
|
0.54634 log10(10*Na/K)
Standard Deviation 2.263355
|
1.06596 log10(10*Na/K)
Standard Deviation 1.257710
|
0.23369 log10(10*Na/K)
Standard Deviation 1.627840
|
|
Determination of the Ratio of Sodium to Potassium (Na/K) in Urine
Day 2; 10-12 h postdose
|
0.34996 log10(10*Na/K)
Standard Deviation 2.319486
|
0.57545 log10(10*Na/K)
Standard Deviation 2.918277
|
0.16923 log10(10*Na/K)
Standard Deviation 5.317341
|
|
Determination of the Ratio of Sodium to Potassium (Na/K) in Urine
Day 2; 12-14h postdose
|
0.30144 log10(10*Na/K)
Standard Deviation 3.085968
|
0.61696 log10(10*Na/K)
Standard Deviation 2.726467
|
0.16288 log10(10*Na/K)
Standard Deviation 4.000192
|
|
Determination of the Ratio of Sodium to Potassium (Na/K) in Urine
Day 2; 14-16h postdose
|
0.23802 log10(10*Na/K)
Standard Deviation 1.551328
|
0.63605 log10(10*Na/K)
Standard Deviation 2.092207
|
0.28266 log10(10*Na/K)
Standard Deviation 1.968431
|
|
Determination of the Ratio of Sodium to Potassium (Na/K) in Urine
Day 2; 16-24h postdose
|
0.37176 log10(10*Na/K)
Standard Deviation 1.372678
|
0.34487 log10(10*Na/K)
Standard Deviation 4.249965
|
0.21423 log10(10*Na/K)
Standard Deviation 2.165262
|
|
Determination of the Ratio of Sodium to Potassium (Na/K) in Urine
Day 3; 24-32h postdose
|
0.81275 log10(10*Na/K)
Standard Deviation 1.231294
|
0.46217 log10(10*Na/K)
Standard Deviation 1.617748
|
0.50869 log10(10*Na/K)
Standard Deviation 1.304142
|
|
Determination of the Ratio of Sodium to Potassium (Na/K) in Urine
Day 3; 32-40h postdose
|
0.79158 log10(10*Na/K)
Standard Deviation 1.432755
|
0.81390 log10(10*Na/K)
Standard Deviation 1.370027
|
0.94041 log10(10*Na/K)
Standard Deviation 1.448171
|
|
Determination of the Ratio of Sodium to Potassium (Na/K) in Urine
Day 3; 40-48h postdose
|
0.88696 log10(10*Na/K)
Standard Deviation 1.412253
|
1.03802 log10(10*Na/K)
Standard Deviation 1.282118
|
0.98064 log10(10*Na/K)
Standard Deviation 1.250503
|
SECONDARY outcome
Timeframe: Day 2Population: This set is a subset of the Safety Set and includes all subjects who completed the study without any findings/events likely affecting PK.
The area under the concentration-time curve (AUC) from time zero (= dosing time) to the time of the last quantifiable concentration (tlast). The collection points used to determine the curve were as follows: predose; and 1, 2, 4, 8, 12, 24 h postdose on Day 2
Outcome measures
| Measure |
Study Arm 1 (Test Arm)Vamorolone
n=10 Participants
single oral dose of vamorolone 20 mg/kg on day 2
\+ Fludrocortisone Challenge Day 1: 1 mg single dose at 9 h predose vamorolone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone dosing.
Vamorolone: vamorolone 20 mg/kg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 2 (Positive Control Arm): Eplerenone
single oral dose of eplerenone 200 mg on day 2
\+ Fludrocortisone challenge Day 1: 1 mg single dose at 9 h predose eplerenone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose eplerenone dosing.
Eplerenone: Eplerenone 200 mg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 3 (Negative Control Arm): no Treatment
Fludrocortisone challenge only Day 1: 1 mg single dose at 9 h predose vamorolone/eplerenone\* dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone/eplerenone\* dosing.
\*or corresponding timepoint for negative control arm
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
|---|---|---|---|
|
Vamorolone PK Parameter AUC0-tlast
|
19802.6 h*ng/ml
Standard Deviation 4422.56
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 2Population: This set is a subset of the Safety Set and includes all subjects who completed the study without any findings/events likely affecting PK.
The AUC from time zero (dosing time) extrapolated to infinity estimated. The collection points used to determine the curve were as follows: predose; and 1, 2, 4, 8, 12, 24 h postdose on Day 2
Outcome measures
| Measure |
Study Arm 1 (Test Arm)Vamorolone
n=10 Participants
single oral dose of vamorolone 20 mg/kg on day 2
\+ Fludrocortisone Challenge Day 1: 1 mg single dose at 9 h predose vamorolone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone dosing.
Vamorolone: vamorolone 20 mg/kg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 2 (Positive Control Arm): Eplerenone
single oral dose of eplerenone 200 mg on day 2
\+ Fludrocortisone challenge Day 1: 1 mg single dose at 9 h predose eplerenone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose eplerenone dosing.
Eplerenone: Eplerenone 200 mg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 3 (Negative Control Arm): no Treatment
Fludrocortisone challenge only Day 1: 1 mg single dose at 9 h predose vamorolone/eplerenone\* dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone/eplerenone\* dosing.
\*or corresponding timepoint for negative control arm
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
|---|---|---|---|
|
Vamorolone PK Parameter AUC0-inf
|
19879.8 h*ng/ml
Standard Deviation 4419.77
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 2Population: This set is a subset of the Safety Set and includes all subjects who completed the study without any findings/events likely affecting PK.
Maximum plasma drug concentration after administration of vamorolone. For this PK measure, the following timepoints were considered: predose; and 1, 2, 4, 8, 12, 24 h postdose on Day 2
Outcome measures
| Measure |
Study Arm 1 (Test Arm)Vamorolone
n=10 Participants
single oral dose of vamorolone 20 mg/kg on day 2
\+ Fludrocortisone Challenge Day 1: 1 mg single dose at 9 h predose vamorolone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone dosing.
Vamorolone: vamorolone 20 mg/kg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 2 (Positive Control Arm): Eplerenone
single oral dose of eplerenone 200 mg on day 2
\+ Fludrocortisone challenge Day 1: 1 mg single dose at 9 h predose eplerenone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose eplerenone dosing.
Eplerenone: Eplerenone 200 mg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 3 (Negative Control Arm): no Treatment
Fludrocortisone challenge only Day 1: 1 mg single dose at 9 h predose vamorolone/eplerenone\* dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone/eplerenone\* dosing.
\*or corresponding timepoint for negative control arm
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
|---|---|---|---|
|
Vamorolone PK Parameter Cmax
|
3942 ng/mL
Standard Deviation 1018.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 2Population: This set is a subset of the Safety Set and includes all subjects who completed the study without any findings/events likely affecting PK.
Time to reach maximum concentration following vamorolone administration. For this PK measure, the following timepoints were considered: predose; and 1, 2, 4, 8, 12, 24 h postdose on Day 2
Outcome measures
| Measure |
Study Arm 1 (Test Arm)Vamorolone
n=10 Participants
single oral dose of vamorolone 20 mg/kg on day 2
\+ Fludrocortisone Challenge Day 1: 1 mg single dose at 9 h predose vamorolone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone dosing.
Vamorolone: vamorolone 20 mg/kg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 2 (Positive Control Arm): Eplerenone
single oral dose of eplerenone 200 mg on day 2
\+ Fludrocortisone challenge Day 1: 1 mg single dose at 9 h predose eplerenone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose eplerenone dosing.
Eplerenone: Eplerenone 200 mg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 3 (Negative Control Arm): no Treatment
Fludrocortisone challenge only Day 1: 1 mg single dose at 9 h predose vamorolone/eplerenone\* dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone/eplerenone\* dosing.
\*or corresponding timepoint for negative control arm
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
|---|---|---|---|
|
Vamorolone PK Parameter Tmax
|
1.992 h
Interval 1.0 to 2.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 2Population: This set is a subset of the Safety Set and includes all subjects who completed the study without any findings/events likely affecting PK.
Elimination half-life is the amount of time it takes for the concentration of a drug in the body to decrease by half. For this PK measure, the following timepoints were considered: predose; and 1, 2, 4, 8, 12, 24 h postdose on Day 2
Outcome measures
| Measure |
Study Arm 1 (Test Arm)Vamorolone
n=10 Participants
single oral dose of vamorolone 20 mg/kg on day 2
\+ Fludrocortisone Challenge Day 1: 1 mg single dose at 9 h predose vamorolone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone dosing.
Vamorolone: vamorolone 20 mg/kg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 2 (Positive Control Arm): Eplerenone
single oral dose of eplerenone 200 mg on day 2
\+ Fludrocortisone challenge Day 1: 1 mg single dose at 9 h predose eplerenone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose eplerenone dosing.
Eplerenone: Eplerenone 200 mg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 3 (Negative Control Arm): no Treatment
Fludrocortisone challenge only Day 1: 1 mg single dose at 9 h predose vamorolone/eplerenone\* dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone/eplerenone\* dosing.
\*or corresponding timepoint for negative control arm
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
|---|---|---|---|
|
Vamorolone PK Parameter t1/2
|
3.170 h
Standard Deviation 0.6253
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 2Population: This set is a subset of the Safety Set and includes all subjects who completed the study without any findings/events likely affecting PK.
The area under the concentration-time curve (AUC) from time zero (= dosing time) to the time of the last quantifiable concentration (tlast).The collection points used to determine the curve were as follows: predose; and 1, 2, 4, 8, 12, 24 h postdose on Day 2
Outcome measures
| Measure |
Study Arm 1 (Test Arm)Vamorolone
n=10 Participants
single oral dose of vamorolone 20 mg/kg on day 2
\+ Fludrocortisone Challenge Day 1: 1 mg single dose at 9 h predose vamorolone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone dosing.
Vamorolone: vamorolone 20 mg/kg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 2 (Positive Control Arm): Eplerenone
single oral dose of eplerenone 200 mg on day 2
\+ Fludrocortisone challenge Day 1: 1 mg single dose at 9 h predose eplerenone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose eplerenone dosing.
Eplerenone: Eplerenone 200 mg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 3 (Negative Control Arm): no Treatment
Fludrocortisone challenge only Day 1: 1 mg single dose at 9 h predose vamorolone/eplerenone\* dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone/eplerenone\* dosing.
\*or corresponding timepoint for negative control arm
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
|---|---|---|---|
|
Eplerenone PK Parameters AUC0-tlast
|
18631.4 h*ng/ml
Standard Deviation 9242.04
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 2Population: This set is a subset of the Safety Set and includes all subjects who completed the study without any findings/events likely affecting PK.
The AUC from time zero (dosing time) extrapolated to infinity. The collection points used to determine the curve were as follows: predose; and 1, 2, 4, 8, 12, 24 h postdose on Day 2
Outcome measures
| Measure |
Study Arm 1 (Test Arm)Vamorolone
n=10 Participants
single oral dose of vamorolone 20 mg/kg on day 2
\+ Fludrocortisone Challenge Day 1: 1 mg single dose at 9 h predose vamorolone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone dosing.
Vamorolone: vamorolone 20 mg/kg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 2 (Positive Control Arm): Eplerenone
single oral dose of eplerenone 200 mg on day 2
\+ Fludrocortisone challenge Day 1: 1 mg single dose at 9 h predose eplerenone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose eplerenone dosing.
Eplerenone: Eplerenone 200 mg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 3 (Negative Control Arm): no Treatment
Fludrocortisone challenge only Day 1: 1 mg single dose at 9 h predose vamorolone/eplerenone\* dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone/eplerenone\* dosing.
\*or corresponding timepoint for negative control arm
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
|---|---|---|---|
|
Eplerenone PK Parameter AUC0-inf
|
19899.9 h*ng/ml
Standard Deviation 11361.57
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 2Population: This set is a subset of the Safety Set and includes all subjects who completed the study without any findings/events likely affecting PK.
Maximum plasma drug concentration after administration of eplerenone. For this PK measure, the following timepoints were considered: predose; and 1, 2, 4, 8, 12, 24 h postdose on Day 2
Outcome measures
| Measure |
Study Arm 1 (Test Arm)Vamorolone
n=10 Participants
single oral dose of vamorolone 20 mg/kg on day 2
\+ Fludrocortisone Challenge Day 1: 1 mg single dose at 9 h predose vamorolone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone dosing.
Vamorolone: vamorolone 20 mg/kg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 2 (Positive Control Arm): Eplerenone
single oral dose of eplerenone 200 mg on day 2
\+ Fludrocortisone challenge Day 1: 1 mg single dose at 9 h predose eplerenone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose eplerenone dosing.
Eplerenone: Eplerenone 200 mg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 3 (Negative Control Arm): no Treatment
Fludrocortisone challenge only Day 1: 1 mg single dose at 9 h predose vamorolone/eplerenone\* dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone/eplerenone\* dosing.
\*or corresponding timepoint for negative control arm
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
|---|---|---|---|
|
Eplerenone PK Parameter Cmax
|
2362 ng/ml
Standard Deviation 551.42
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 2Time to reach to the maximum concentration after eplerenone. For this PK measure, the following timepoints were considered: predose; and 1, 2, 4, 8, 12, 24 h postdose on Day 2
Outcome measures
| Measure |
Study Arm 1 (Test Arm)Vamorolone
n=10 Participants
single oral dose of vamorolone 20 mg/kg on day 2
\+ Fludrocortisone Challenge Day 1: 1 mg single dose at 9 h predose vamorolone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone dosing.
Vamorolone: vamorolone 20 mg/kg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 2 (Positive Control Arm): Eplerenone
single oral dose of eplerenone 200 mg on day 2
\+ Fludrocortisone challenge Day 1: 1 mg single dose at 9 h predose eplerenone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose eplerenone dosing.
Eplerenone: Eplerenone 200 mg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 3 (Negative Control Arm): no Treatment
Fludrocortisone challenge only Day 1: 1 mg single dose at 9 h predose vamorolone/eplerenone\* dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone/eplerenone\* dosing.
\*or corresponding timepoint for negative control arm
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
|---|---|---|---|
|
Eplerenone PK Parameter Tmax
|
2.000 h
Interval 0.97 to 2.02
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 2Population: This set is a subset of the Safety Set and includes all subjects who completed the study without any findings/events likely affecting PK.
Elimination half-life is the amount of time it takes for the concentration of a drug in the body to decrease by half. For this PK measure, the following timepoints were considered: predose; and 1, 2, 4, 8, 12, 24 h postdose on Day 2
Outcome measures
| Measure |
Study Arm 1 (Test Arm)Vamorolone
n=10 Participants
single oral dose of vamorolone 20 mg/kg on day 2
\+ Fludrocortisone Challenge Day 1: 1 mg single dose at 9 h predose vamorolone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone dosing.
Vamorolone: vamorolone 20 mg/kg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 2 (Positive Control Arm): Eplerenone
single oral dose of eplerenone 200 mg on day 2
\+ Fludrocortisone challenge Day 1: 1 mg single dose at 9 h predose eplerenone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose eplerenone dosing.
Eplerenone: Eplerenone 200 mg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 3 (Negative Control Arm): no Treatment
Fludrocortisone challenge only Day 1: 1 mg single dose at 9 h predose vamorolone/eplerenone\* dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone/eplerenone\* dosing.
\*or corresponding timepoint for negative control arm
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
|---|---|---|---|
|
Eplerenone PK Parameter t1/2
|
4.453 h
Standard Deviation 2.2996
|
—
|
—
|
Adverse Events
Study Arm 1 (Test Arm)Vamorolone
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Study Arm 2 (Positive Control Arm): Eplerenone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Study Arm 3 (Negative Control Arm): no Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Study Arm 1 (Test Arm)Vamorolone
n=10 participants at risk
single oral dose of vamorolone 20 mg/kg on day 2
\+ Fludrocortisone Challenge Day 1: 1 mg single dose at 9 h predose vamorolone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone dosing.
Vamorolone: vamorolone 20 mg/kg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 2 (Positive Control Arm): Eplerenone
n=10 participants at risk
single oral dose of eplerenone 200 mg on day 2
\+ Fludrocortisone challenge Day 1: 1 mg single dose at 9 h predose eplerenone dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose eplerenone dosing.
Eplerenone: Eplerenone 200 mg single dose on Day 2
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
Study Arm 3 (Negative Control Arm): no Treatment
n=10 participants at risk
Fludrocortisone challenge only Day 1: 1 mg single dose at 9 h predose vamorolone/eplerenone\* dosing. Day 2: 0.1 mg and 0.5 mg multiple doses. For detailed timepoints, see protocol Section 4.1. Day 3: 0.1 mg single dose at 24 h postdose vamorolone/eplerenone\* dosing.
\*or corresponding timepoint for negative control arm
Fludrocortisone: Fludrocortisone challenge on Days 1 to 3 (for all subjects):
Day 1:
-Fludrocortisone 1 mg at 9 h predose vamorolone /eplerenone administration/corresponding timepoint for negative control arm
Day 2:
* Fludrocortisone 0.5 mg at the same time of vamorolone/eplerenone administration in the morning (0 h) /corresponding timepoint for negative control arm.
* Fludrocortisone 0.1 mg at 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 14 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
* Fludrocortisone 0.5 mg at 16 h vamorolone/eplerenone postdose administration/corresponding timepoint for negative control arm.
Day 3:
-Fludrocortisone 0.1 mg at 24 h vamorolone/eplerenone postdose administration on Day 2/corresponding timepoint for negative control arm.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • All adverse events AEs)and serious AE(SAEs) were collected from the signing of the informed consent until the safety follow-up phone call on Day11. All SAEs were to be recorded & reported to the sponsor within 24hours of awareness,filing in the safety form provided. Investigators were not obligated to actively seek AEs or SAEs after conclusion of the study participation. If the investigator learned of any SADR (SAE considered related to the IMP) at any time it had to be reported to the sponsor
|
0.00%
0/10 • All adverse events AEs)and serious AE(SAEs) were collected from the signing of the informed consent until the safety follow-up phone call on Day11. All SAEs were to be recorded & reported to the sponsor within 24hours of awareness,filing in the safety form provided. Investigators were not obligated to actively seek AEs or SAEs after conclusion of the study participation. If the investigator learned of any SADR (SAE considered related to the IMP) at any time it had to be reported to the sponsor
|
0.00%
0/10 • All adverse events AEs)and serious AE(SAEs) were collected from the signing of the informed consent until the safety follow-up phone call on Day11. All SAEs were to be recorded & reported to the sponsor within 24hours of awareness,filing in the safety form provided. Investigators were not obligated to actively seek AEs or SAEs after conclusion of the study participation. If the investigator learned of any SADR (SAE considered related to the IMP) at any time it had to be reported to the sponsor
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10 • All adverse events AEs)and serious AE(SAEs) were collected from the signing of the informed consent until the safety follow-up phone call on Day11. All SAEs were to be recorded & reported to the sponsor within 24hours of awareness,filing in the safety form provided. Investigators were not obligated to actively seek AEs or SAEs after conclusion of the study participation. If the investigator learned of any SADR (SAE considered related to the IMP) at any time it had to be reported to the sponsor
|
20.0%
2/10 • Number of events 2 • All adverse events AEs)and serious AE(SAEs) were collected from the signing of the informed consent until the safety follow-up phone call on Day11. All SAEs were to be recorded & reported to the sponsor within 24hours of awareness,filing in the safety form provided. Investigators were not obligated to actively seek AEs or SAEs after conclusion of the study participation. If the investigator learned of any SADR (SAE considered related to the IMP) at any time it had to be reported to the sponsor
|
0.00%
0/10 • All adverse events AEs)and serious AE(SAEs) were collected from the signing of the informed consent until the safety follow-up phone call on Day11. All SAEs were to be recorded & reported to the sponsor within 24hours of awareness,filing in the safety form provided. Investigators were not obligated to actively seek AEs or SAEs after conclusion of the study participation. If the investigator learned of any SADR (SAE considered related to the IMP) at any time it had to be reported to the sponsor
|
|
Vascular disorders
Circulatory collaspse
|
0.00%
0/10 • All adverse events AEs)and serious AE(SAEs) were collected from the signing of the informed consent until the safety follow-up phone call on Day11. All SAEs were to be recorded & reported to the sponsor within 24hours of awareness,filing in the safety form provided. Investigators were not obligated to actively seek AEs or SAEs after conclusion of the study participation. If the investigator learned of any SADR (SAE considered related to the IMP) at any time it had to be reported to the sponsor
|
10.0%
1/10 • Number of events 1 • All adverse events AEs)and serious AE(SAEs) were collected from the signing of the informed consent until the safety follow-up phone call on Day11. All SAEs were to be recorded & reported to the sponsor within 24hours of awareness,filing in the safety form provided. Investigators were not obligated to actively seek AEs or SAEs after conclusion of the study participation. If the investigator learned of any SADR (SAE considered related to the IMP) at any time it had to be reported to the sponsor
|
0.00%
0/10 • All adverse events AEs)and serious AE(SAEs) were collected from the signing of the informed consent until the safety follow-up phone call on Day11. All SAEs were to be recorded & reported to the sponsor within 24hours of awareness,filing in the safety form provided. Investigators were not obligated to actively seek AEs or SAEs after conclusion of the study participation. If the investigator learned of any SADR (SAE considered related to the IMP) at any time it had to be reported to the sponsor
|
Additional Information
Shabir Hasham MD, Chief Medical Officer
Santhera Pharmaceuticals LTD
Phone: +41 79 520 95 18
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place