NCT06167707CompletedPhase 1
Pharmacokinetics and Pharmacodynamics of Subcutaneous vs Intravenous Furosemide in Healthy Volunteers
Open-label, Single-dose, Randomized, Two-way Crossover Study to Compare the Pharmacokinetics and Pharmacodynamics of Subcutaneous Injection of SCP-111 (Furosemide) vs Intravenous Injection of Furosemide in Healthy Volunteers
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 4 Dec 2023
- Start date
- 19 Apr 2024
- Primary completion date
- 14 Jun 2024
- Lead sponsor
- scPharmaceuticals, Inc.
- Diseases
- Heart failure
- NCT number
- NCT06167707
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 21
- From 19 Apr 2024 to the primary completion date, 14 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Administration of intravenous radiographic contrast agent within 72 hours prior to Screening.
- Concomitant or any use within past 30 days of drugs known to interact with furosemide (aminoglycoside antibiotics, ethacrynic acid, high doses of salicylates, cisplatin, tubocurarine, succinylcholine, chloral hydrate, phenytoin, methotrexate, indomethacin, or lithium).
- Administration of an investigational drug or implantation of investigational device, or participation in another interventional clinical trial, within 30 days prior to Screening.
- Positive urine drug screen at Screening or Baseline.
Other illness
- Heart rate \> 110 beats per minute (BPM) at screening or baseline.
- Other significant cardiac abnormalities which may interfere with study participation or study assessments.
- Presence of implanted ventricular assist device, cardiac defibrillator or pacemaker.
- Urinary retention due to bladder emptying disorders and/or urethral narrowing.
- Reported history of hepatic cirrhosis.
- Any surgical or medical condition which in the opinion of the investigator may interfere with participation in the study or which may affect the outcome of the study.
- History of severe allergic or hypersensitivity reactions to furosemide or any component of the SCP-111 formulation (tromethamine or benzyl alcohol)
Lab values
- Serum potassium \< 3.0 or \> 5.5 mEq/L at screening.
- Severely impaired renal function, defined as an estimated glomerular filtration rate (eGFR) at screening admission \< 30 mL/min/1.73m2, calculated using the simplified Modification of Diet in Renal Disease (sMDRD) equation.
- Blood alcohol concentration \> 2 mg/dL (0.02%) at Screening.
- Alcohol breath test \> 2 mg/dL (0.02%) on admission to the CRU.
Age
- Pregnant or lactating women or women of childbearing age who are not willing to use an adequate form of contraception.
Other
- Systolic BP (SBP) \< 90 mmHg at screening or baseline.
- Temperature \> 38°C (oral or equivalent).
- Presence or need for urinary catheterization.
Who the study is looking for
- 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.
Age in the registry: 45 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Elixia EPCT, LLC Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.