- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06167707
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
This study aims to compare the pharmacokinetics and pharmacodynamics of intravenous (IV) and subcutaneous (SC) 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is an open-label, single-center, single-dose, randomized, two-way crossover study in healthy volunteers. Each Subject will complete Screening, Baseline, Treatment, and Follow-up Phases.
After a Screening Phase, Subjects meeting entry criteria will be admitted to the clinical research unit (CRU) and undergo baseline assessments. Subjects will be randomly assigned in a 1:1 ratio to 1 of 2 treatment sequences (IV furosemide followed by SC or vice versa). Subjects will remain domiciled in the CRU for each treatment period which will be about 12-hours. After final assessments are performed, Subjects may be discharged from the CRU if safety parameters are acceptable to the Investigator and return to the CRU after a 3-day washout period to receive the second treatment sequence. The Follow-up Phase will occur 24-48 hours after discharge from the CRU following treatment sequence 2, completing Subjects' study participation.
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: scPharmaceuticals Inc.
- Phone Number: 781-301-6704
- Email: info@scpharma.com
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33618
- Recruiting
- Elixia EPCT, LLC
-
Contact:
- Harry Alcorn, PharmD
- Phone Number: 612-618-1002
- Email: HAlcorn@elixiahealth.com
-
Principal Investigator:
- Fadi Saba, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
- 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 < 30 mL/min/1.73m2, calculated using the simplified Modification of Diet in Renal Disease (sMDRD) equation.
- Urinary retention due to bladder emptying disorders and/or urethral narrowing.
- Presence or need for urinary catheterization.
- Reported history of hepatic cirrhosis.
- 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.
- 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.
- Positive urine drug screen at Screening or Baseline.
- Blood alcohol concentration > 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Sequence 1
Period 1: SC Period 2: IV
|
Furosemide injection 80 mg/mL, 80 mg SC via autoinjector x 1 dose
Furosemide injection, USP 10 mg/mL, 40 mg IV over 2 minutes followed by 40 mg 2 hours later
|
Experimental: Treatment Sequence 2
Period 1: IV Period 2: SC
|
Furosemide injection 80 mg/mL, 80 mg SC via autoinjector x 1 dose
Furosemide injection, USP 10 mg/mL, 40 mg IV over 2 minutes followed by 40 mg 2 hours later
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUClast
Time Frame: 12 hours
|
The area under the plasma concentration versus time curve from time 0 (pre-dose) to the last quantifiable time point.
|
12 hours
|
AUCinf
Time Frame: 12 hours
|
The area under the plasma concentration-time curve from time 0 (pre-dose) to time of last measurable plasma concentration.
|
12 hours
|
Cmax
Time Frame: 12 hours
|
Maximum observed plasma concentration of Furosemide
|
12 hours
|
Tmax
Time Frame: 12 hours
|
Time to achieve maximum observed Furosemide plasma concentration
|
12 hours
|
λz
Time Frame: 12 hours
|
Apparent plasma terminal-phase elimination rate constant
|
12 hours
|
t½
Time Frame: 12 hours
|
Terminal-phase half life
|
12 hours
|
V
Time Frame: 12 hours
|
Systemic volume of distribution, terminal phase, for IV furosemide
|
12 hours
|
Vz/F
Time Frame: 12 hours
|
Apparent volume of distribution, terminal phase, for SC furosemide
|
12 hours
|
CL
Time Frame: 12 hours
|
Systemic clearance for IV furosemide
|
12 hours
|
CL/F
Time Frame: 12 hours
|
Apparent systemic clearance for SC furosemide
|
12 hours
|
Urine Output
Time Frame: 6 hour, 8 hour and 12 hour
|
Total Urine Output
|
6 hour, 8 hour and 12 hour
|
Urinary Sodium
Time Frame: 6 hour, 8 hour and 12 hour
|
Urinary sodium excretion
|
6 hour, 8 hour and 12 hour
|
Urinary Potassium
Time Frame: 6 hour, 8 hour and 12 hour
|
Urinary potassium excretion
|
6 hour, 8 hour and 12 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: Day 0 through Day 5 visit
|
Adverse Events (AEs) and Serious Adverse Events (SAEs)
|
Day 0 through Day 5 visit
|
Injection Site Pain
Time Frame: 12 hours
|
Injection site pain will be assessed using an 11-point scale where 0 is equivalent to no pain and 10 is equivalent to the worst possible pain.
For IV administration, the 11-point pain scale will be performed.
|
12 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- scP-04-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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