Trial Outcomes & Findings for Pharmacokinetics and Pharmacodynamics of Subcutaneous vs Intravenous Furosemide in Healthy Volunteers (NCT NCT06167707)
NCT ID: NCT06167707
Last Updated: 2026-03-30
Results Overview
Maximum observed plasma concentration of Furosemide
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
21 participants
Primary outcome timeframe
SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.
Results posted on
2026-03-30
Participant Flow
6 participants did not meet inclusion/exclusion criteria after signing informed consent. * 3 not included due to Investigator's opinion * 2 excluded due to concomitant use of drugs known to interact with furosemide within 30 days * 1 excluded due to surgical or medical condition that could interfere with participation/outcome Per protocol, participants that did not meet inclusion/exclusion criteria after signing informed consent were not considered enrolled.
Participant milestones
| Measure |
Treatment Sequence 1 (SC Period 1; IV Period 2)
SCP-111: Furosemide injection 80 mg/mL, 80 mg SC via autoinjector x 1 dose
Furosemide USP: Furosemide injection, USP 10 mg/mL, 40 mg IV over 2 minutes followed by 40 mg 2 hours later
|
Treatment Sequence 2 (IV Period 1; SC Period 2)
SCP-111: Furosemide injection 80 mg/mL, 80 mg SC via autoinjector x 1 dose
Furosemide USP: Furosemide injection, USP 10 mg/mL, 40 mg IV over 2 minutes followed by 40 mg 2 hours later
|
|---|---|---|
|
Period 1
STARTED
|
10
|
11
|
|
Period 1
COMPLETED
|
10
|
11
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
10
|
11
|
|
Period 2
COMPLETED
|
9
|
11
|
|
Period 2
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Treatment Sequence 1 (SC Period 1; IV Period 2)
SCP-111: Furosemide injection 80 mg/mL, 80 mg SC via autoinjector x 1 dose
Furosemide USP: Furosemide injection, USP 10 mg/mL, 40 mg IV over 2 minutes followed by 40 mg 2 hours later
|
Treatment Sequence 2 (IV Period 1; SC Period 2)
SCP-111: Furosemide injection 80 mg/mL, 80 mg SC via autoinjector x 1 dose
Furosemide USP: Furosemide injection, USP 10 mg/mL, 40 mg IV over 2 minutes followed by 40 mg 2 hours later
|
|---|---|---|
|
Period 2
Physician Decision
|
1
|
0
|
Baseline Characteristics
Pharmacokinetics and Pharmacodynamics of Subcutaneous vs Intravenous Furosemide in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Treatment Sequence 1 (SC Period 1; IV Period 2)
n=10 Participants
SCP-111: Furosemide injection 80 mg/mL, 80 mg SC via autoinjector x 1 dose
Furosemide USP: Furosemide injection, USP 10 mg/mL, 40 mg IV over 2 minutes followed by 40 mg 2 hours later
|
Treatment Sequence 2 (IV Period 1; SC Period 2)
n=11 Participants
SCP-111: Furosemide injection 80 mg/mL, 80 mg SC via autoinjector x 1 dose
Furosemide USP: Furosemide injection, USP 10 mg/mL, 40 mg IV over 2 minutes followed by 40 mg 2 hours later
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.3 Years
STANDARD_DEVIATION 8.43 • n=4 Participants
|
57.0 Years
STANDARD_DEVIATION 8.09 • n=28 Participants
|
57.6 Years
STANDARD_DEVIATION 8.07 • n=10 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=4 Participants
|
8 Participants
n=28 Participants
|
15 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=4 Participants
|
3 Participants
n=28 Participants
|
6 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=4 Participants
|
4 Participants
n=28 Participants
|
5 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=4 Participants
|
7 Participants
n=28 Participants
|
16 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=4 Participants
|
3 Participants
n=28 Participants
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=4 Participants
|
8 Participants
n=28 Participants
|
17 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=4 Participants
|
11 participants
n=28 Participants
|
21 participants
n=10 Participants
|
|
Height
|
167.058 cm
STANDARD_DEVIATION 12.334 • n=4 Participants
|
167.808 cm
STANDARD_DEVIATION 11.924 • n=28 Participants
|
167.451 cm
STANDARD_DEVIATION 11.819 • n=10 Participants
|
|
Weight
|
80.95 kg
STANDARD_DEVIATION 32.71 • n=4 Participants
|
78.82 kg
STANDARD_DEVIATION 13.75 • n=28 Participants
|
79.83 kg
STANDARD_DEVIATION 24.03 • n=10 Participants
|
|
BMI
|
28.37 kg/m^2
STANDARD_DEVIATION 9.233 • n=4 Participants
|
27.84 kg/m^2
STANDARD_DEVIATION 3.152 • n=28 Participants
|
28.09 kg/m^2
STANDARD_DEVIATION 6.588 • n=10 Participants
|
|
eGFR
|
82.0 mL/min/1.73m2
STANDARD_DEVIATION 24.2 • n=4 Participants
|
85.2 mL/min/1.73m2
STANDARD_DEVIATION 20.5 • n=28 Participants
|
83.7 mL/min/1.73m2
STANDARD_DEVIATION 21.8 • n=10 Participants
|
PRIMARY outcome
Timeframe: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose. IV:Population: Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111.
Area under the plasma concentration-time curve from time 0 (pre-dose) to time of last measurable plasma concentration.
Outcome measures
| Measure |
SC SCP-111
n=19 Participants
Injection Site Pain Assessments after a successful SC dosing regimen
|
IV Furosemide
n=19 Participants
Injection Site Pain Assessments after a successful IV dosing regimen
|
|---|---|---|
|
AUClast
|
12470.092 ng*hr/mL
Standard Deviation 4009.749
|
11684.297 ng*hr/mL
Standard Deviation 3452.712
|
PRIMARY outcome
Timeframe: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.Population: Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111.
Area under the plasma concentration-time curve from time 0 (pre-dose) extrapolated to infinity.
Outcome measures
| Measure |
SC SCP-111
n=19 Participants
Injection Site Pain Assessments after a successful SC dosing regimen
|
IV Furosemide
n=19 Participants
Injection Site Pain Assessments after a successful IV dosing regimen
|
|---|---|---|
|
AUCinf
|
12713.768 ng*hr/mL
Standard Deviation 4116.867
|
11780.478 ng*hr/mL
Standard Deviation 3506.531
|
PRIMARY outcome
Timeframe: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.Population: Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111.
The percentage of the AUC that is extrapolated beyond the last measurable concentration.
Outcome measures
| Measure |
SC SCP-111
n=19 Participants
Injection Site Pain Assessments after a successful SC dosing regimen
|
IV Furosemide
n=19 Participants
Injection Site Pain Assessments after a successful IV dosing regimen
|
|---|---|---|
|
AUCext
|
1.856 Percentage (%)
Standard Deviation 1.036
|
0.768 Percentage (%)
Standard Deviation 0.317
|
PRIMARY outcome
Timeframe: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.Population: Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111.
Maximum observed plasma concentration of Furosemide
Outcome measures
| Measure |
SC SCP-111
n=19 Participants
Injection Site Pain Assessments after a successful SC dosing regimen
|
IV Furosemide
n=19 Participants
Injection Site Pain Assessments after a successful IV dosing regimen
|
|---|---|---|
|
Cmax
|
4532.916 ng/mL
Standard Deviation 1497.679
|
10087.570 ng/mL
Standard Deviation 2804.669
|
PRIMARY outcome
Timeframe: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.Population: Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111.
Time of maximum observed Furosemide plasma concentration
Outcome measures
| Measure |
SC SCP-111
n=19 Participants
Injection Site Pain Assessments after a successful SC dosing regimen
|
IV Furosemide
n=19 Participants
Injection Site Pain Assessments after a successful IV dosing regimen
|
|---|---|---|
|
Tmax
|
0.750 hour
Interval 0.5 to 1.5
|
2.080 hour
Interval 0.08 to 2.12
|
PRIMARY outcome
Timeframe: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.Population: Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111
Apparent plasma terminal-phase elimination rate constant
Outcome measures
| Measure |
SC SCP-111
n=19 Participants
Injection Site Pain Assessments after a successful SC dosing regimen
|
IV Furosemide
n=19 Participants
Injection Site Pain Assessments after a successful IV dosing regimen
|
|---|---|---|
|
λz
|
0.32033 1/hr
Standard Deviation 0.04491
|
0.37466 1/hr
Standard Deviation 0.08628
|
PRIMARY outcome
Timeframe: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.Population: Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111.
Terminal-phase half-life
Outcome measures
| Measure |
SC SCP-111
n=19 Participants
Injection Site Pain Assessments after a successful SC dosing regimen
|
IV Furosemide
n=19 Participants
Injection Site Pain Assessments after a successful IV dosing regimen
|
|---|---|---|
|
t½
|
2.204 hour
Standard Deviation 0.308
|
1.928 hour
Standard Deviation 0.367
|
PRIMARY outcome
Timeframe: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.Population: Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111.
Systemic clearance for IV furosemide (CL) and Apparent systemic clearance for SC furosemide (CL/F)
Outcome measures
| Measure |
SC SCP-111
n=19 Participants
Injection Site Pain Assessments after a successful SC dosing regimen
|
IV Furosemide
n=19 Participants
Injection Site Pain Assessments after a successful IV dosing regimen
|
|---|---|---|
|
Clearance
|
6.872 Liter per hour
Standard Deviation 1.997
|
7.319 Liter per hour
Standard Deviation 1.974
|
PRIMARY outcome
Timeframe: SC SCP-111: 0, 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12 hours post-dose. IV Furosemide: 0, 5, 15, 30, 45 minutes and 1, 1.5, 2 hours after 1st IV dose; 5, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 hours after 2nd IV dose.Population: Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111.
Systemic Volume of distribution, terminal phase for IV furosemide (V) and Apparent Volume of distribution, terminal phase for SC furosemide (Vz/F)
Outcome measures
| Measure |
SC SCP-111
n=19 Participants
Injection Site Pain Assessments after a successful SC dosing regimen
|
IV Furosemide
n=19 Participants
Injection Site Pain Assessments after a successful IV dosing regimen
|
|---|---|---|
|
Volume of Distribution, Terminal Phase
|
21.476 Liter
Standard Deviation 5.636
|
19.839 Liter
Standard Deviation 4.848
|
PRIMARY outcome
Timeframe: 0-1, 1-2, 2-3, 3-4, 4-5, 5-6 hours post-dosePopulation: Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111.
Total Urine Output from 0 to 6 hours
Outcome measures
| Measure |
SC SCP-111
n=19 Participants
Injection Site Pain Assessments after a successful SC dosing regimen
|
IV Furosemide
n=19 Participants
Injection Site Pain Assessments after a successful IV dosing regimen
|
|---|---|---|
|
Urine Output 0-6 Hours
|
3.1943 Liter
Standard Deviation 0.8807
|
2.9159 Liter
Standard Deviation 0.7225
|
PRIMARY outcome
Timeframe: 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8 hours post-dosePopulation: Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111.
Total Urine Output from 0 to 8 hours
Outcome measures
| Measure |
SC SCP-111
n=19 Participants
Injection Site Pain Assessments after a successful SC dosing regimen
|
IV Furosemide
n=19 Participants
Injection Site Pain Assessments after a successful IV dosing regimen
|
|---|---|---|
|
Urine Output 0-8 Hours
|
3.5164 Liter
Standard Deviation 0.8951
|
3.1888 Liter
Standard Deviation 0.7945
|
PRIMARY outcome
Timeframe: 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8, 8-10, 10-12 hours post-dosePopulation: Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111.
Total Urine Output from 0 to 12 hours
Outcome measures
| Measure |
SC SCP-111
n=19 Participants
Injection Site Pain Assessments after a successful SC dosing regimen
|
IV Furosemide
n=19 Participants
Injection Site Pain Assessments after a successful IV dosing regimen
|
|---|---|---|
|
Urine Output 0-12 Hours
|
3.9889 Liter
Standard Deviation 0.9592
|
3.6999 Liter
Standard Deviation 0.9475
|
PRIMARY outcome
Timeframe: 0-1, 1-2, 2-3, 3-4, 4-5, 5-6 hours post-dosePopulation: Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111.
Urinary sodium excretion from 0 to 6 hours
Outcome measures
| Measure |
SC SCP-111
n=19 Participants
Injection Site Pain Assessments after a successful SC dosing regimen
|
IV Furosemide
n=19 Participants
Injection Site Pain Assessments after a successful IV dosing regimen
|
|---|---|---|
|
Urinary Sodium 0-6 Hours
|
276.046 mmol
Standard Deviation 111.121
|
258.463 mmol
Standard Deviation 98.661
|
PRIMARY outcome
Timeframe: 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8 hours post-dosePopulation: Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111.
Urinary sodium excretion from 0 to 8 hours
Outcome measures
| Measure |
SC SCP-111
n=18 Participants
Injection Site Pain Assessments after a successful SC dosing regimen
|
IV Furosemide
n=19 Participants
Injection Site Pain Assessments after a successful IV dosing regimen
|
|---|---|---|
|
Urinary Sodium 0-8 Hours
|
280.047 mmol
Standard Deviation 117.757
|
263.704 mmol
Standard Deviation 101.165
|
PRIMARY outcome
Timeframe: 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8, 8-10, 10-12 hours post-dosePopulation: Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111.
Urinary sodium excretion from 0 to 12 hours
Outcome measures
| Measure |
SC SCP-111
n=18 Participants
Injection Site Pain Assessments after a successful SC dosing regimen
|
IV Furosemide
n=19 Participants
Injection Site Pain Assessments after a successful IV dosing regimen
|
|---|---|---|
|
Urinary Sodium 0-12 Hours
|
288.448 mmol
Standard Deviation 120.642
|
272.501 mmol
Standard Deviation 102.888
|
PRIMARY outcome
Timeframe: 0-1, 1-2, 2-3, 3-4, 4-5, 5-6 hours post-dosePopulation: Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111.
Urinary potassium excretion from 0 to 6 hours
Outcome measures
| Measure |
SC SCP-111
n=19 Participants
Injection Site Pain Assessments after a successful SC dosing regimen
|
IV Furosemide
n=19 Participants
Injection Site Pain Assessments after a successful IV dosing regimen
|
|---|---|---|
|
Urinary Potassium 0-6 Hours
|
41.809 mEq
Standard Deviation 10.490
|
39.292 mEq
Standard Deviation 14.635
|
PRIMARY outcome
Timeframe: 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8 hours post-dosePopulation: Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111.
Urinary potassium excretion from 0 to 8 hours
Outcome measures
| Measure |
SC SCP-111
n=18 Participants
Injection Site Pain Assessments after a successful SC dosing regimen
|
IV Furosemide
n=19 Participants
Injection Site Pain Assessments after a successful IV dosing regimen
|
|---|---|---|
|
Urinary Potassium 0-8 Hours
|
47.037 mEq
Standard Deviation 11.649
|
44.463 mEq
Standard Deviation 16.148
|
PRIMARY outcome
Timeframe: 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8, 8-10, 10-12 hours post-dosePopulation: Bioavailability Population: All participants in the Pharmacokinetic (PK) Population who had a sufficient number of samples collected for estimation of PK parameters after receiving both IV furosemide and SC SCP-111.
Urinary potassium excretion from 0 to 12 hours
Outcome measures
| Measure |
SC SCP-111
n=18 Participants
Injection Site Pain Assessments after a successful SC dosing regimen
|
IV Furosemide
n=19 Participants
Injection Site Pain Assessments after a successful IV dosing regimen
|
|---|---|---|
|
Urinary Potassium 0-12 Hours
|
55.051 mEq
Standard Deviation 14.075
|
52.561 mEq
Standard Deviation 17.926
|
SECONDARY outcome
Timeframe: SC SCP-111: pre-dose, immediately after dose, 15, 30 minutes and 6,12 hours post-dose. IV Furosemide: pre-dose, after place IV needle, immediately after 1st IV dose; 15, 30, minutes, immediately after 2nd dose,15, 30 minutes and 4, 10 hours after 2nd dosePopulation: Safety Population: All randomized participants who received at least 1 dose of either study drug and provided at least 1 post-baseline safety assessment.
Injection site pain was assessed using an 11-point scale where 0 was equivalent to no pain and 10 was equivalent to the worst possible pain.
Outcome measures
| Measure |
SC SCP-111
n=21 Participants
Injection Site Pain Assessments after a successful SC dosing regimen
|
IV Furosemide
n=20 Participants
Injection Site Pain Assessments after a successful IV dosing regimen
|
|---|---|---|
|
Injection Site Pain
|
0.0 score on a scale
Interval 0.0 to 3.0
|
0.0 score on a scale
Interval 0.0 to 2.0
|
Adverse Events
SC SCP-111
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
IV Furosemide
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SC SCP-111
n=21 participants at risk
Pharmacokinetic Assessments after a successful SC dosing regimen
|
IV Furosemide
n=20 participants at risk
Pharmacokinetic Assessments after a successful IV dosing regimen
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.8%
1/21 • Day 0 through Day 5 Visit
An AE is any untoward medical occurrence associated with the use of a Study Treatment or Study Drug in humans, whether considered related to the Study Treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Disability/incapacity * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement
|
0.00%
0/20 • Day 0 through Day 5 Visit
An AE is any untoward medical occurrence associated with the use of a Study Treatment or Study Drug in humans, whether considered related to the Study Treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Disability/incapacity * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement
|
Other adverse events
| Measure |
SC SCP-111
n=21 participants at risk
Pharmacokinetic Assessments after a successful SC dosing regimen
|
IV Furosemide
n=20 participants at risk
Pharmacokinetic Assessments after a successful IV dosing regimen
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/21 • Day 0 through Day 5 Visit
An AE is any untoward medical occurrence associated with the use of a Study Treatment or Study Drug in humans, whether considered related to the Study Treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Disability/incapacity * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement
|
10.0%
2/20 • Day 0 through Day 5 Visit
An AE is any untoward medical occurrence associated with the use of a Study Treatment or Study Drug in humans, whether considered related to the Study Treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Disability/incapacity * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement
|
|
Gastrointestinal disorders
Nausea
|
9.5%
2/21 • Day 0 through Day 5 Visit
An AE is any untoward medical occurrence associated with the use of a Study Treatment or Study Drug in humans, whether considered related to the Study Treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Disability/incapacity * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement
|
0.00%
0/20 • Day 0 through Day 5 Visit
An AE is any untoward medical occurrence associated with the use of a Study Treatment or Study Drug in humans, whether considered related to the Study Treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Disability/incapacity * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
1/21 • Day 0 through Day 5 Visit
An AE is any untoward medical occurrence associated with the use of a Study Treatment or Study Drug in humans, whether considered related to the Study Treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Disability/incapacity * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement
|
0.00%
0/20 • Day 0 through Day 5 Visit
An AE is any untoward medical occurrence associated with the use of a Study Treatment or Study Drug in humans, whether considered related to the Study Treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Disability/incapacity * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement
|
|
General disorders
Injection site pain
|
33.3%
7/21 • Day 0 through Day 5 Visit
An AE is any untoward medical occurrence associated with the use of a Study Treatment or Study Drug in humans, whether considered related to the Study Treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Disability/incapacity * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement
|
0.00%
0/20 • Day 0 through Day 5 Visit
An AE is any untoward medical occurrence associated with the use of a Study Treatment or Study Drug in humans, whether considered related to the Study Treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Disability/incapacity * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement
|
|
General disorders
Injection site bruising
|
9.5%
2/21 • Day 0 through Day 5 Visit
An AE is any untoward medical occurrence associated with the use of a Study Treatment or Study Drug in humans, whether considered related to the Study Treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Disability/incapacity * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement
|
5.0%
1/20 • Day 0 through Day 5 Visit
An AE is any untoward medical occurrence associated with the use of a Study Treatment or Study Drug in humans, whether considered related to the Study Treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Disability/incapacity * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement
|
|
General disorders
Injection site erythema
|
14.3%
3/21 • Day 0 through Day 5 Visit
An AE is any untoward medical occurrence associated with the use of a Study Treatment or Study Drug in humans, whether considered related to the Study Treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Disability/incapacity * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement
|
0.00%
0/20 • Day 0 through Day 5 Visit
An AE is any untoward medical occurrence associated with the use of a Study Treatment or Study Drug in humans, whether considered related to the Study Treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Disability/incapacity * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement
|
|
General disorders
Injection site mass
|
4.8%
1/21 • Day 0 through Day 5 Visit
An AE is any untoward medical occurrence associated with the use of a Study Treatment or Study Drug in humans, whether considered related to the Study Treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Disability/incapacity * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement
|
0.00%
0/20 • Day 0 through Day 5 Visit
An AE is any untoward medical occurrence associated with the use of a Study Treatment or Study Drug in humans, whether considered related to the Study Treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Disability/incapacity * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement
|
|
General disorders
Injection site pruritus
|
4.8%
1/21 • Day 0 through Day 5 Visit
An AE is any untoward medical occurrence associated with the use of a Study Treatment or Study Drug in humans, whether considered related to the Study Treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Disability/incapacity * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement
|
0.00%
0/20 • Day 0 through Day 5 Visit
An AE is any untoward medical occurrence associated with the use of a Study Treatment or Study Drug in humans, whether considered related to the Study Treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Disability/incapacity * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.8%
1/21 • Day 0 through Day 5 Visit
An AE is any untoward medical occurrence associated with the use of a Study Treatment or Study Drug in humans, whether considered related to the Study Treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Disability/incapacity * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement
|
0.00%
0/20 • Day 0 through Day 5 Visit
An AE is any untoward medical occurrence associated with the use of a Study Treatment or Study Drug in humans, whether considered related to the Study Treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Disability/incapacity * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
23.8%
5/21 • Day 0 through Day 5 Visit
An AE is any untoward medical occurrence associated with the use of a Study Treatment or Study Drug in humans, whether considered related to the Study Treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Disability/incapacity * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement
|
20.0%
4/20 • Day 0 through Day 5 Visit
An AE is any untoward medical occurrence associated with the use of a Study Treatment or Study Drug in humans, whether considered related to the Study Treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Disability/incapacity * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement
|
|
Nervous system disorders
Dizziness
|
0.00%
0/21 • Day 0 through Day 5 Visit
An AE is any untoward medical occurrence associated with the use of a Study Treatment or Study Drug in humans, whether considered related to the Study Treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Disability/incapacity * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement
|
5.0%
1/20 • Day 0 through Day 5 Visit
An AE is any untoward medical occurrence associated with the use of a Study Treatment or Study Drug in humans, whether considered related to the Study Treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Disability/incapacity * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement
|
|
Vascular disorders
Hypotension
|
0.00%
0/21 • Day 0 through Day 5 Visit
An AE is any untoward medical occurrence associated with the use of a Study Treatment or Study Drug in humans, whether considered related to the Study Treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Disability/incapacity * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement
|
5.0%
1/20 • Day 0 through Day 5 Visit
An AE is any untoward medical occurrence associated with the use of a Study Treatment or Study Drug in humans, whether considered related to the Study Treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Disability/incapacity * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement
|
Additional Information
Senior Vice President, Therapeutic Area Head, Respiratory and Cardiorenal
MannKind Corporation
Phone: 203-796-3407
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place