Phase 1 N=21 Randomized Treatment

Pharmacokinetics and Pharmacodynamics of Subcutaneous vs Intravenous Furosemide in Healthy Volunteers

Heart Failure · Fluid Overload

Bottom Line

View on ClinicalTrials.gov: NCT06167707 ↗

Enrolled (actual)

Serious AEs

2.4%

Results posted

Mar 2026

Primary outcome: Primary: AUClast — 12470.092; 11684.297 ng*hr/mL

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: SCP-111 (Drug); Furosemide USP (Drug)
Age: Adult, Older Adult · 45+ yrs
Sex: All
Sponsor: scPharmaceuticals, Inc.
Primary completion: Jun 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY AUClast	12470.092; 11684.297	—
PRIMARY AUCinf	12713.768; 11780.478	—
PRIMARY AUCext	1.856; 0.768	—
PRIMARY Cmax	4532.916; 10087.570	—
PRIMARY Tmax	0.750; 2.080	—
PRIMARY λz	0.32033; 0.37466	—
PRIMARY t½	2.204; 1.928	—
PRIMARY Clearance	6.872; 7.319	—
PRIMARY Volume of Distribution, Terminal Phase	21.476; 19.839	—
PRIMARY Urine Output 0-6 Hours	3.1943; 2.9159	—
PRIMARY Urine Output 0-8 Hours	3.5164; 3.1888	—
PRIMARY Urine Output 0-12 Hours	3.9889; 3.6999	—
PRIMARY Urinary Sodium 0-6 Hours	276.046; 258.463	—
PRIMARY Urinary Sodium 0-8 Hours	280.047; 263.704	—
PRIMARY Urinary Sodium 0-12 Hours	288.448; 272.501	—
PRIMARY Urinary Potassium 0-6 Hours	41.809; 39.292	—
PRIMARY Urinary Potassium 0-8 Hours	47.037; 44.463	—
PRIMARY Urinary Potassium 0-12 Hours	55.051; 52.561	—
SECONDARY Injection Site Pain	0.0; 0.0	—

Summary

This study aims to compare the pharmacokinetics and pharmacodynamics of subcutaneous (SC) and intravenous (IV) furosemide. The test formulation in this study is furosemide injection, 80 mg/1 mL, buffered to a neutral pH for SC administration via an autoinjector. A commercial formulation of furosemide injection, USP, solution 10 mg/mL administered as a 40 mg IV injection over 2 minutes followed by a second dose of 40 mg, 2 hours later, will serve as the reference drug. The objectives of this study are: * To estimate the bioavailability and describe the pharmacokinetics and pharmacodynamics of furosemide administered as SC injection via autoinjector compared with equivalent dose of furosemide administered as two 40 mg IV injections, two hours apart. * To describe the safety and tolerability of furosemide administered as SC injection via an autoinjector.

Eligibility Criteria

Inclusion Criteria

An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
Male and female subjects 45 to 80 years of age.
Has the ability to understand the requirements of the study and is willing to comply with all study procedures.
In the opinion of the Investigator, able to participate in the study.

Exclusion Criteria

Pregnant or lactating women or women of childbearing age who are not willing to use an adequate form of contraception.
Systolic BP (SBP) 110 beats per minute (BPM) at screening or baseline.
Temperature > 38°C (oral or equivalent).
Serum potassium 5.5 mEq/L at screening.
Other significant cardiac abnormalities which may interfere with study participation or study assessments.
Current or planned treatment during the study with any IV therapies, including inotropic agents, vasopressors, levosimendan, nesiritide or analogues. scPharmaceuticals, Inc. SCP-111 PK/PD Study Protocol Number: scP-04-001 Confidential Page 14 of 56
Presence of implanted ventricular assist device, cardiac defibrillator or pacemaker.
Severely impaired renal function, defined as an estimated glomerular filtration rate (eGFR) at screening admission 2 mg/dL (0.02%) at Screening.
Alcohol breath test > 2 mg/dL (0.02%) on admission to the CRU.
History of severe allergic or hypersensitivity reactions to furosemide or any component of the SCP-111 formulation (tromethamine or benzyl alcohol)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06167707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.