Heart FailurePhase 2/3NCT02329834
Crossover Study to Compare the Pharmacokinetics and Bioavailability of a Novel Furosemide Regimen Administered Subcutaneously vs. the Same Dose Administered Intravenously in Subjects With Chronic Heart Failure
A Phase 2/3 study testing Fursemide Injection Solution for subcutaneous administration (80 mg) and Furosemide Injection, USP in people with Heart Failure, run by scPharmaceuticals, Inc. at 1 site in United States.
Trial summary
The proposed study aims to compare the pharmacokinetics and bioavailability of intravenous and subcutaneous Furosemide. Although these regimens are not intended to be bioequivalent, they are both expected to achieve therapeutic plasma levels and induce effective diuresis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Fursemide Injection Solution for subcutaneous administration (80 mg) and Furosemide Injection, USP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Oct 2015
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
- Male and female subjects ≥18 years of age, with body volume and weight <130 kg and body mass index (BMI) <38 kg/m2
- Females will be non-pregnant, non-lactating, and post-menopausal, surgically sterile (e.g., tubal ligation, hysterectomy), or use TWO (2) of the following forms of contraception: IUD, IUD with spermicide, female condom with spermicide, contraceptive sponge with spermicide, an intravaginal system, diaphragm with spermicide, cervical cap with spermicide, a male sexual partner who agrees to use a male condom with spermicide, a sterile sexual partner, OR abstinence
- History of at least 3 months treated heart failure (NYHA class II/III) with presence of symptoms of chronic volume overload requiring ongoing treatment with oral furosemide at a dose of ≥ 40 mg per day for at least 30 days prior to baseline
- NT-proBNP > 300 pg/mL or BNP > 100 pg/mL
- Agrees to abstain from using alcohol, caffeine-containing products, and tobacco-/nicotine-containing products through CRU discharge (period 2).
- Able to participate in the study in the opinion of the investigator
- Has the ability to understand the requirements of the study and is willing to comply with all study procedures
Who cannot join
- Acute Decompensated Heart Failure (ADHF) or recent history of hospitalization for heart failure in the last 4 weeks
- Worsening of signs or symptoms of heart failure in the two weeks prior to the Screening, or those expected to require intravenous loop diuretics or in-patient treatment for heart failure during the study
- Systolic BP (SBP) < 90 mm Hg
- Temperature > 38°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment
- Serum sodium < 130 mEq/L and Serum potassium < 3.0 mEq/L
- Significant other cardiac abnormalities which may interfere with study participation or study assessments
Show all 22Show fewer
- Current or planned treatment during the study with any IV therapies, including inotropic agents, vasopressors, levosimendan, nesiritide or analogues; or mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device)
- Diagnosed with Type I diabetes mellitus or Type II diabetes requiring insulin therapy
- Presence or need for urinary catheterization, urinary tract abnormality, or disorder interfering with urination
- Impaired renal function, defined as an estimated glomerular filtration rate (eGFR) on admission < 45 mL/min/1.73m2, calculated using the simplified Modification of Diet in Renal Disease (sMDRD) equation
- Indication of moderate-to-severe hepatic dysfunctions as determined by the investigator
- Administration of intravenous radiographic contrast agent within 72 hours prior to Screening or acute contrast-induced nephropathy at the time of Screening
- Major surgery within 30 days prior to Screening
- Administration of an investigational drug or implantation of investigational device, or participation in another interventional 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 test for hepatitis B, hepatitis C, or HIV at Screening
- Positive urine drug screen at Screening or Baseline
- Concomitant use of any drugs known to interact with furosemide
- History of alcohol abuse within 6 months prior to screening, as determined by the Investigator
- Positive alcohol breath test on admission to the CRU
- History of severe allergic or hypersensitivity reactions to furosemide
- Donation of greater than 100 mL of either whole blood or plasma within 30 days prior to study drug administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Single-dose, Randomized, Two-way (Two-period) Crossover Study to Compare the Pharmacokinetics and Bioavailability of a Novel Furosemide Regimen Administered Subcutaneously Versus the Same Dose (80mg) Administered Intravenously in Subjects With Chronic Heart Failure
The proposed study aims to compare the pharmacokinetics and bioavailability of intravenous and subcutaneous Furosemide. Although these regimens are not intended to be bioequivalent, they are both expected to achieve therapeutic plasma levels and induce effective diuresis.
The test formulation in this study is a buffered solution, Furosemide Injection Solution at 8 mg/mL at pH 7.4 (range 7.0 to 7.8) and is intended for SC injection according to the instructions in the protocol. A commercial formulation of Furosemide Injection, USP will serve as the reference drug in this study, which will be administered by IV bolus. It contains furosemide 10 mg/mL in solution at alkaline pH of 8.0 to 9.3 and is marketed for IV and IM injection.
Read more
The objectives of this study are:
- To characterize the pharmacokinetics of furosemide administered by continuous subcutaneous infusion using a biphasic delivery profile.
- To estimate the absolute bioavailability of furosemide administered by continuous subcutaneous infusion compared with an equivalent dose of furosemide administered by intravenous bolus administration.
Read the detailed description
This study will be an open-label, single-center, single-dose, randomized, two-way (two-period) crossover study in 16 adult subjects previously diagnosed with mild to moderate heart failure (NYHA class II/III) being treated concomitantly with oral furosemide therapy at a dose of ≥ 40 mg/day. Each subject will complete Screening, Baseline, Treatment, and Follow-Up Phases. The Screening Phase will be conducted on an outpatient basis between 14 and 3 days prior to Baseline. Subjects will be instructed to maintain a < 2 gm sodium diet within 3 days prior to Baseline. Baseline (Day 0) consists of clinical research unit (CRU) admission and final qualification assessments. The Treatment Phase will comprise two crossover periods separated by a 7-day outpatient fluid re-equilibration washout. Following CRU admission, subjects will discontinue oral furosemide at least 24 hours prior to administration of study drug for each Crossover Period. Subjects will be randomly assigned in a 1:1 ratio to 1 of 2 treatment sequences to receive both intravenous (IV) and subcutaneous (SC) furosemide in Crossover Periods (i.e., IV followed by SC or vice versa). Subjects will remain domiciled in the CRU for each Crossover Period during the Treatment Phase through 24 hours after administration of study drug, after which time they will be discharged if safety parameters are acceptable to the Investigator. Oral furosemide therapy will be re-initiated at discharge after Crossover Period 1 (i.e., during the 7-day fluid re-equilibration washout) and after Crossover Period 2. The Follow-Up Phase will occur 7 days (± 1) after discharge from the CRU following Crossover Period 2, completing subjects' study participation.
- Conditions
- Heart Failure
- Being tested
- Fursemide Injection Solution for subcutaneous administration (80 mg), Furosemide Injection, USP
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fursemide Injection Solution for subcutaneous administration (80 mg)Drug
Furosemide Injection Solution, 10mL of undiluted buffered furosemide solution (8mg/mL)
Furosemide Injection, USPDrug
Furosemide Injection, USP (10mg/mL), 80 mg by intravenous administration.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence 1 | Experimental | Furosemide Injection Solution for subcutaneous administration (80mg) over 5 hours followed by i.v. Furosemide Injection, USP (80 mg)by i.v. bolus in second period Receives: Drug: Fursemide Injection Solution for subcutaneous administration (80 mg); Drug: Furosemide Injection, USP |
| Treatment Sequence 2 | Experimental | Furosemide Injection, USP (80 mg) by i.v. bolus, followed by Furosemide Injection Solution for subcutaneous administration (80mg) over 5 hours in second period. Receives: Drug: Fursemide Injection Solution for subcutaneous administration (80 mg); Drug: Furosemide Injection, USP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed plasma concentration of Furosemide
Measured: 0, 5 min, 15 min, 30 min, 45 min, 60 min, 1.5 hours, 2 hours, 2:05 min, 2:15 min, 2:30 min, 2:45 min, 3 hours, 3:30 min, 4, 5, 6, 8, 10, 12, 14, and 16 hours post-dose
Tmax
Time to achieve maximum observed Furosemide plasma concentration
Measured: 0, 5 min, 15 min, 30 min, 45 min, 60 min, 1.5 hours, 2 hours, 2:05 min, 2:15 min, 2:30 min, 2:45 min, 3 hours, 3:30 min, 4, 5, 6, 8, 10, 12, 14, and 16 hours post-dose
AUClast
The area under the plasma concentration versus time curve from time 0 (pre-dose) to the last quantifiable time point.
Measured: 0, 5 min, 15 min, 30 min, 45 min, 60 min, 1.5 hours, 2 hours, 2:05 min, 2:15 min, 2:30 min, 2:45 min, 3 hours, 3:30 min, 4, 5, 6, 8, 10, 12, 14, and 16 hours post-dose
AUCinf
The area under the plasma concentration-time curve from time 0 (pre-dose) to time of last measurable plasma concentration.
Measured: 0, 5 min, 15 min, 30 min, 45 min, 60 min, 1.5 hours, 2 hours, 2:05 min, 2:15 min, 2:30 min, 2:45 min, 3 hours, 3:30 min, 4, 5, 6, 8, 10, 12, 14, and 16 hours post-dose
AUCext
The percentage of AUC that is extrapolated beyond the last measurable concentration
Measured: 0, 5 min, 15 min, 30 min, 45 min, 60 min, 1.5 hours, 2 hours, 2:05 min, 2:15 min, 2:30 min, 2:45 min, 3 hours, 3:30 min, 4, 5, 6, 8, 10, 12, 14, and 16 hours post-dose
λz
Apparent plasma terminal-phase elimination rate constant
Measured: 24 hours
t 1/2
Terminal-phase half life
Measured: 24 hours
Volume of Distribution, Terminal Phase
Systemic Volume of distribution, terminal phase for IV furosemide and Apparent Volume of distribution, terminal phase for SC furosemide
Measured: 24 hours
CL
Systemic Clearance for IV furosemide and Apparent Systemic Clearance for SC furosemide
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2015 (estimated)
- Study startApr 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- scPharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce G. Rankin, DO, CPI, MRO, FACOFP, Principal investigator, Avail Clnical Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329834
- Sponsor's protocol ID
- scP-01-002
- Status last verified
- Nov 2022
- First submitted
- 22 Dec 2014
- Last updated
- 2 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Single-dose, Randomized, Two-way (Two-period) Crossover Study to Compare the Pharmacokinetics and Bioavailability of a Novel Furosemide Regimen Administered Subcutaneously Versus the Same Dose (80mg) Administered Intravenously in Subjects With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT02329834
- Acronym / sponsor ID
- scP-01-002
- Conditions
- Heart Failure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- scPharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 1 Jan 2015 (estimated)
- Results
- Posted 2 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study aims to compare the pharmacokinetics and bioavailability of intravenous and subcutaneous Furosemide. Although these regimens are not intended to be bioequivalent, they are both expected to achieve therapeutic plasma levels and induce effective diuresis.
The test formulation in this study is a buffered solution, Furosemide Injection Solution at 8 mg/mL at pH 7.4 (range 7.0 to 7.8) and is intended for SC injection according to the instructions in the protocol. A commercial formulation of Furosemide Injection, USP will serve as the reference drug in this study, which will be administered by IV bolus. It contains furosemide 10 mg/mL in solution at alkaline pH of 8.0 to 9.3 and is marketed for IV and IM injection.
The objectives of this study are:
- To characterize the pharmacokinetics of furosemide administered by continuous subcutaneous infusion using a biphasic delivery profile.
- To estimate the absolute bioavailability of furosemide administered by continuous subcutaneous infusion compared with an equivalent dose of furosemide administered by intravenous bolus administration.
Detailed description
This study will be an open-label, single-center, single-dose, randomized, two-way (two-period) crossover study in 16 adult subjects previously diagnosed with mild to moderate heart failure (NYHA class II/III) being treated concomitantly with oral furosemide therapy at a dose of ≥ 40 mg/day. Each subject will complete Screening, Baseline, Treatment, and Follow-Up Phases. The Screening Phase will be conducted on an outpatient basis between 14 and 3 days prior to Baseline. Subjects will be instructed to maintain a < 2 gm sodium diet within 3 days prior to Baseline. Baseline (Day 0) consists of clinical research unit (CRU) admission and final qualification assessments. The Treatment Phase will comprise two crossover periods separated by a 7-day outpatient fluid re-equilibration washout. Following CRU admission, subjects will discontinue oral furosemide at least 24 hours prior to administration of study drug for each Crossover Period. Subjects will be randomly assigned in a 1:1 ratio to 1 of 2 treatment sequences to receive both intravenous (IV) and subcutaneous (SC) furosemide in Crossover Periods (i.e., IV followed by SC or vice versa). Subjects will remain domiciled in the CRU for each Crossover Period during the Treatment Phase through 24 hours after administration of study drug, after which time they will be discharged if safety parameters are acceptable to the Investigator. Oral furosemide therapy will be re-initiated at discharge after Crossover Period 1 (i.e., during the 7-day fluid re-equilibration washout) and after Crossover Period 2. The Follow-Up Phase will occur 7 days (± 1) after discharge from the CRU following Crossover Period 2, completing subjects' study participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence 1 | Experimental | Drug: Fursemide Injection Solution for subcutaneous administration (80 mg), Drug: Furosemide Injection, USPFurosemide Injection Solution for subcutaneous administration (80mg) over 5 hours followed by i.v. Furosemide Injection, USP (80 mg)by i.v. bolus in second period |
| Treatment Sequence 2 | Experimental | Drug: Fursemide Injection Solution for subcutaneous administration (80 mg), Drug: Furosemide Injection, USPFurosemide Injection, USP (80 mg) by i.v. bolus, followed by Furosemide Injection Solution for subcutaneous administration (80mg) over 5 hours in second period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
- Male and female subjects ≥18 years of age, with body volume and weight <130 kg and body mass index (BMI) <38 kg/m2
- Females will be non-pregnant, non-lactating, and post-menopausal, surgically sterile (e.g., tubal ligation, hysterectomy), or use TWO (2) of the following forms of contraception: IUD, IUD with spermicide, female condom with spermicide, contraceptive sponge with spermicide, an intravaginal system, diaphragm with spermicide, cervical cap with spermicide, a male sexual partner who agrees to use a male condom with spermicide, a sterile sexual partner, OR abstinence
- History of at least 3 months treated heart failure (NYHA class II/III) with presence of symptoms of chronic volume overload requiring ongoing treatment with oral furosemide at a dose of ≥ 40 mg per day for at least 30 days prior to baseline
- NT-proBNP > 300 pg/mL or BNP > 100 pg/mL
Key exclusion criteria (22 listed)
- Acute Decompensated Heart Failure (ADHF) or recent history of hospitalization for heart failure in the last 4 weeks
- Worsening of signs or symptoms of heart failure in the two weeks prior to the Screening, or those expected to require intravenous loop diuretics or in-patient treatment for heart failure during the study
- Systolic BP (SBP) < 90 mm Hg
- Temperature > 38°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment
- Serum sodium < 130 mEq/L and Serum potassium < 3.0 mEq/L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fursemide Injection Solution for subcutaneous administration (80 mg)Furosemide Injection Solution, 10mL of undiluted buffered furosemide solution (8mg/mL) | Drug | Treatment Sequence 1, Treatment Sequence 2 |
| Furosemide Injection, USPFurosemide Injection, USP (10mg/mL), 80 mg by intravenous administration. | Drug | Treatment Sequence 1, Treatment Sequence 2 |
Primary outcome
Cmax
Time frame: 0, 5 min, 15 min, 30 min, 45 min, 60 min, 1.5 hours, 2 hours, 2:05 min, 2:15 min, 2:30 min, 2:45 min, 3 hours, 3:30 min, 4, 5, 6, 8, 10, 12, 14, and 16 hours post-dose
Maximum observed plasma concentration of Furosemide
Tmax
Time frame: 0, 5 min, 15 min, 30 min, 45 min, 60 min, 1.5 hours, 2 hours, 2:05 min, 2:15 min, 2:30 min, 2:45 min, 3 hours, 3:30 min, 4, 5, 6, 8, 10, 12, 14, and 16 hours post-dose
Time to achieve maximum observed Furosemide plasma concentration
AUClast
Time frame: 0, 5 min, 15 min, 30 min, 45 min, 60 min, 1.5 hours, 2 hours, 2:05 min, 2:15 min, 2:30 min, 2:45 min, 3 hours, 3:30 min, 4, 5, 6, 8, 10, 12, 14, and 16 hours post-dose
The area under the plasma concentration versus time curve from time 0 (pre-dose) to the last quantifiable time point.
AUCinf
Time frame: 0, 5 min, 15 min, 30 min, 45 min, 60 min, 1.5 hours, 2 hours, 2:05 min, 2:15 min, 2:30 min, 2:45 min, 3 hours, 3:30 min, 4, 5, 6, 8, 10, 12, 14, and 16 hours post-dose
The area under the plasma concentration-time curve from time 0 (pre-dose) to time of last measurable plasma concentration.
AUCext
Time frame: 0, 5 min, 15 min, 30 min, 45 min, 60 min, 1.5 hours, 2 hours, 2:05 min, 2:15 min, 2:30 min, 2:45 min, 3 hours, 3:30 min, 4, 5, 6, 8, 10, 12, 14, and 16 hours post-dose
The percentage of AUC that is extrapolated beyond the last measurable concentration
λz
Time frame: 24 hours
Apparent plasma terminal-phase elimination rate constant
t 1/2
Time frame: 24 hours
Terminal-phase half life
Volume of Distribution, Terminal Phase
Time frame: 24 hours
Systemic Volume of distribution, terminal phase for IV furosemide and Apparent Volume of distribution, terminal phase for SC furosemide
CL
Time frame: 24 hours
Systemic Clearance for IV furosemide and Apparent Systemic Clearance for SC furosemide
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Subcutaneous Furosemide in Heart Failure: Pharmacokinetic Characteristics of a Newly Buffered SolutionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce G. Rankin, DO, CPI, MRO, FACOFP principal investigator
Avail Clnical Research, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fursemide Injection Solution for subcutaneous administration (80 mg) and Furosemide Injection, USP in people with Heart Failure, run by scPharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: 0, 5 min, 15 min, 30 min, 45 min, 60 min, 1.5 hours, 2 hours, 2:05 min, 2:15 min, 2:30 min, 2:45 min, 3 hours, 3:30 min, 4, 5, 6, 8, 10, 12, 14, and 16 hours post-dose). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022.