An Open Label Study to Evaluate the Impact of Duration of Subcutaneous Infusion of a Novel, pH Neutral Formulation of Furosemide (Furoscix®) on Safety and Local Skin Tolerability

Completed · Phase 1

Conditions studied: Healthy

In brief

This is a Phase 1 study to evaluate the safety and tolerability of shortened subcutaneous infusions of Furoscix.

Key facts

Study ID

NCT04161482

Run by

scPharmaceuticals, Inc.

People needed

39

Starts

2019-12-02

Expected to finish

2020-06-26

Last updated by the study team

2020-07-10

Who can join

Age: 45 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects are eligible for inclusion only if all of the following criteria are met:
• An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
• Male and female Subjects 45-80 years of age.
• Have 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.

You may not qualify if…

• A Subject is not eligible for inclusion if any of the following criteria apply:
• Receipt of loop diuretics (furosemide, bumetanide or torsemide) or thiazide diuretics (hydrochlorothiazide or metolazone) within 24 hours of study drug.
• Receipt of potassium-sparing diuretics (spironolactone, amiloride) or oral calcium, potassium or magnesium supplements (including multi-vitamins) within 24 hours of study drug.
• History of allergy to furosemide, sulfonamides or other loop diuretics.
• Any skin conditions currently requiring medical therapy.
• History of diabetes.
• Presence or need for urinary catheterization, urinary tract abnormality or disorder interfering with urination.
• Serum sodium <130 mEq/L at screening.
• Serum potassium < 3.5 or > 5.5 mEq/L at screening.
• Serum magnesium < 1.5 or > 2.5 mEq/L at screening.
• Serum chloride < 96 or > 106 mEq/L at screening.
• Serum calcium < 8.5 or > 10.5 mg/dL at screening.
• Estimated Glomerular Filtration Rate (GFR) < 30 mL/min/1.73 m2 by simplified Modification of Diet in Renal Disease (sMDRD) equation at screening.
• Systolic BP (SBP) < 90 mm Hg at screening or baseline.
• Heart rate > 110 beats per minute (BPM) at screening or baseline.
• History of tinnitus or hearing impairment, including deafness.
• Temperature > 38°C (oral or equivalent) at screening or baseline.
• Blood alcohol concentration > 2 mg/dL (0.02%) at screening or baseline.
• Female Subject who is pregnant or lactating.
• History of major abdominal surgery affecting the needle placement site.
• History of benign prostatic hyperplasia (BPH), prostatitis or prostate cancer.
• Urinary retention due to bladder emptying disorders and/or urethral narrowing.
• History of liver disease, cirrhosis, or ascites.
• Any local abdominal skin condition on the day of treatment i.e. sunburn, rash, eczema, etc.
• Allergies and/or sensitivities to adhesive bandages or medical tape.

Where it is running

• Aventiv Clinical Research — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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