CompletedPhase 1

Pharmacokinetics and Pharmacodynamics of Subcutaneous vs Intravenous Furosemide in Healthy Volunteers

United States21 participantsStarted 2024-04-19

Plain-language 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.

Who can participate

Age range45 Years – 80 Years

SexALL

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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) \< 90 mmHg at screening or baseline.
✕. Heart rate \> 110 beats per minute (BPM) at screening or baseline.
✕. Temperature \> 38°C (oral or equivalent).
✕. Serum potassium \< 3.0 or \> 5.5 mEq/L at screening.
✕

What they're measuring

AUClast

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:

AUCinf

AUCext

Cmax

Tmax

λz

Trial details

NCT IDNCT06167707

SponsorscPharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-14

Results submitted2026-02-18

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