Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06167707 | Pharmacokinetics and Pharmacodynamics of Subcutaneous vs Intravenous Furosemide in Healthy Volunteers | PHASE1 | COMPLETED | 21 | — | — | Apr 19, 2024 | Jun 14, 2024 | Mar 30, 2026 | 1 | United States |
Area under the plasma concentration-time curve from time 0 (pre-dose) to time of last measurable plasma concentration.
Area under the plasma concentration-time curve from time 0 (pre-dose) extrapolated to infinity.
The percentage of the AUC that is extrapolated beyond the last measurable concentration.
Maximum observed plasma concentration of Furosemide
Time of maximum observed Furosemide plasma concentration
Apparent plasma terminal-phase elimination rate constant
Terminal-phase half-life
Systemic clearance for IV furosemide (CL) and Apparent systemic clearance for SC furosemide (CL/F)
Systemic Volume of distribution, terminal phase for IV furosemide (V) and Apparent Volume of distribution, terminal phase for SC furosemide (Vz/F)
Total Urine Output from 0 to 6 hours
Total Urine Output from 0 to 8 hours
Total Urine Output from 0 to 12 hours
Urinary sodium excretion from 0 to 6 hours
Urinary sodium excretion from 0 to 8 hours
Urinary sodium excretion from 0 to 12 hours
Urinary potassium excretion from 0 to 6 hours
Urinary potassium excretion from 0 to 8 hours
Urinary potassium excretion from 0 to 12 hours
| Arm | Type | Description |
|---|---|---|
| Treatment Sequence 1 | EXPERIMENTAL | Period 1: SC Period 2: IV |
| Treatment Sequence 2 | EXPERIMENTAL | Period 1: IV Period 2: SC |
| Name | Type | Description |
|---|---|---|
| SCP-111 | DRUG | Furosemide injection 80 mg/mL, 80 mg SC via autoinjector x 1 dose |
| Furosemide USP | DRUG | Furosemide injection, USP 10 mg/mL, 40 mg IV over 2 minutes followed by 40 mg 2 hours later |
Inclusion Criteria: 1. An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities. 2. Male and female subjects 45 to 80 years of age. 3. Has the ability to understand the requirements of the study and is willing to comply with all study p...